How did scientists isolate the influenza virus. When was the first flu vaccine licensed for civilian use. What key developments shaped the history of influenza vaccination. How many doses of flu vaccine are manufactured annually. Why do flu vaccines need annual adjustments.

The Origins of Influenza Research: Isolating the Virus

The journey towards developing an effective flu vaccine began in the early 20th century, with crucial discoveries paving the way for subsequent breakthroughs. In 1933, scientists made a pivotal finding by isolating influenza A viruses, definitively proving that the flu was caused by viruses rather than bacteria. This revelation marked a significant shift in our understanding of the disease and set the stage for targeted vaccine development.

Just three years later, in 1936, researchers isolated the influenza B virus, further expanding our knowledge of the different strains responsible for seasonal flu outbreaks. Concurrently, scientists made another critical discovery: the flu virus could be grown in hen’s eggs. This finding would prove instrumental in the eventual production of flu vaccines on a large scale.

The Role of Egg-Based Cultivation in Vaccine Development

The ability to grow influenza viruses in hen’s eggs was a game-changer for vaccine research. This technique allowed scientists to cultivate large quantities of the virus in a controlled environment, providing the raw material necessary for vaccine production. Even today, many flu vaccines are still produced using egg-based technology, although newer methods have also been developed.

The Birth of the First Flu Vaccine: A Wartime Achievement

As World War II raged on, the urgency to protect soldiers and civilians from influenza intensified research efforts. In 1942, scientists achieved a significant milestone by producing a two-component vaccine that offered protection against both influenza A and B viruses. This bivalent vaccine laid the groundwork for more comprehensive protection against multiple flu strains.

The culmination of these efforts came in 1945 when the first flu vaccine was licensed for civilian use in the United States. This achievement marked the beginning of a new era in public health, offering a powerful tool to combat seasonal flu outbreaks and potentially mitigate the impact of future pandemics.

Dr. Jonas Salk: From Flu to Polio

Among the researchers who contributed to the development of the flu vaccine was Dr. Jonas Salk, who would later gain worldwide fame for his work on the polio vaccine. Salk’s involvement in flu vaccine research during the 1940s provided him with valuable experience that he would apply to his groundbreaking work on polio in the following decade.

The Challenge of Viral Mutation: Adapting Vaccines to Evolving Threats

In 1947, scientists made a crucial observation that would shape the future of flu vaccination strategies: influenza viruses change from year to year. This discovery highlighted the need for annual adjustments to the vaccine composition to ensure its effectiveness against the most prevalent strains.

Why do flu viruses mutate so frequently? The influenza virus has a segmented genome that allows for easy genetic reassortment, leading to rapid changes in its surface proteins. These mutations can result in new strains that may partially or completely evade the immune protection provided by previous vaccines or infections.

The Annual Flu Shot: A Moving Target

The realization that flu viruses evolve rapidly led to the establishment of the annual flu shot recommendation. Each year, global surveillance networks monitor circulating flu strains, and experts use this data to predict which variants are most likely to cause infections in the coming season. Vaccine manufacturers then produce updated formulations to match these predictions, ensuring the best possible protection against the ever-changing threat of influenza.

Expanding Vaccination Recommendations: Protecting Vulnerable Populations

As understanding of influenza’s impact on different demographic groups grew, vaccination recommendations expanded accordingly. In 1960, the U.S. Surgeon General made a significant announcement, recommending annual flu shots for three key groups:

• People with chronic debilitating diseases
• Individuals aged 65 years or older
• Pregnant women

These recommendations acknowledged the increased risk of severe complications from influenza in certain populations and aimed to provide targeted protection to those most vulnerable.

Broadening the Scope: Vaccinating Children and Adolescents

In 2008, the CDC’s Advisory Committee on Immunization Practices (ACIP) took another significant step by recommending annual flu vaccination for children and adolescents aged 5 to 18 years. This expansion built upon previous recommendations for younger children, recognizing the role of school-aged individuals in the transmission of influenza within communities.

Innovations in Vaccine Delivery: Beyond the Needle

While injectable vaccines have been the mainstay of flu prevention for decades, researchers have explored alternative delivery methods to improve vaccination rates and efficacy. In 2003, a major breakthrough occurred with the licensing of the first nasal spray flu vaccine in the United States.

How does the nasal spray flu vaccine work? Unlike traditional injectable vaccines that use inactivated viruses, the nasal spray contains live attenuated influenza viruses (LAIV). These weakened viruses can replicate in the cooler temperatures of the nasal passages but cannot survive in the warmer temperatures of the lower respiratory tract. This approach mimics natural infection more closely, potentially providing broader immune protection.

Advantages and Considerations of Nasal Spray Vaccines

The introduction of nasal spray flu vaccines offered several potential benefits:

• Needle-free administration, which may be preferable for individuals with needle phobias
• Easier administration in mass vaccination settings
• Potential for stronger immune response in some populations, particularly children

However, it’s important to note that nasal spray vaccines are not recommended for all age groups or individuals with certain health conditions. Healthcare providers can help determine the most appropriate flu vaccine option for each person based on their age, health status, and other factors.

Scaling Up Production: Meeting Global Demand

As flu vaccination became more widely recommended and accepted, manufacturers had to dramatically increase production capacity to meet growing demand. In the 2020-2021 flu season, nearly 200 million doses of flu vaccine were expected to be distributed in the United States alone.

This massive scale-up in production represents a remarkable achievement in public health infrastructure and manufacturing capabilities. It also highlights the importance of careful planning and coordination between health authorities, researchers, and pharmaceutical companies to ensure an adequate supply of vaccines each year.

The Impact of COVID-19 on Flu Vaccination Efforts

The COVID-19 pandemic has brought renewed attention to the importance of vaccination against respiratory viruses. Health officials have strongly emphasized the need for flu vaccination to prevent a potential “twindemic” scenario, where healthcare systems could be overwhelmed by simultaneous surges of influenza and COVID-19 cases.

This heightened awareness may lead to increased flu vaccination rates in the coming years, potentially reducing the overall burden of seasonal influenza on public health systems.

Lessons from History: Pandemics and Vaccine Development

The development of the flu vaccine was largely driven by the devastating impact of the 1918 influenza pandemic, which infected an estimated 500 million people worldwide and claimed approximately 675,000 lives in the United States alone. This global health crisis underscored the urgent need for effective preventive measures against influenza.

How does the timeline for flu vaccine development compare to modern vaccine research? While it took nearly three decades from the 1918 pandemic to the licensing of the first flu vaccine in 1945, recent advancements in vaccine technology and research methodologies have significantly accelerated the process. The rapid development of COVID-19 vaccines in less than a year demonstrates the potential for swift responses to emerging infectious threats when resources and global cooperation are mobilized.

The 1976 Swine Flu Vaccination Program: A Cautionary Tale

Not all vaccination efforts have been without controversy. In 1976, an outbreak of swine flu among Army recruits at Fort Dix, New Jersey, led to a massive vaccination program that aimed to inoculate about 25% of the U.S. population in just 10 months. However, the program was halted due to reports of a rare neurological condition called Guillain-Barré syndrome (GBS) associated with the vaccine.

This incident serves as a reminder of the importance of ongoing safety monitoring and the need to balance potential risks with public health benefits. Today, the CDC maintains that if there is an increased risk of GBS following flu vaccination, it is very small, estimated at one to two additional cases per million doses administered.

The Future of Flu Vaccination: Emerging Technologies and Challenges

As we look to the future of influenza prevention, several exciting developments and ongoing challenges are shaping the landscape of vaccine research and development:

Universal Flu Vaccines: The Holy Grail of Influenza Research

Scientists are working towards developing a “universal” flu vaccine that could provide broad protection against multiple strains of influenza, potentially eliminating the need for annual vaccinations. These efforts focus on targeting conserved regions of the virus that are less likely to mutate, offering the promise of longer-lasting immunity against a wider range of flu strains.

mRNA Technology: Lessons from COVID-19

The success of mRNA-based COVID-19 vaccines has sparked interest in applying this technology to influenza vaccines. mRNA vaccines could potentially offer faster production times and greater flexibility in responding to emerging flu strains, improving the match between circulating viruses and vaccine composition.

Addressing Vaccine Hesitancy

Despite the proven benefits of flu vaccination, vaccine hesitancy remains a significant challenge. Public health officials and healthcare providers must continue to educate the public about the importance of annual flu shots and address common misconceptions about vaccine safety and efficacy.

Global Surveillance and Cooperation

Maintaining and expanding global influenza surveillance networks is crucial for identifying emerging strains and guiding vaccine development. International cooperation in sharing data and resources will be essential for staying ahead of the ever-evolving influenza threat.

As we reflect on the 75-year history of flu vaccines, it’s clear that significant progress has been made in our ability to prevent and mitigate the impact of seasonal influenza. However, the challenge of staying ahead of this rapidly mutating virus remains. Continued investment in research, innovation, and public health infrastructure will be crucial in our ongoing efforts to protect global populations from the threat of influenza.

How Long Did It Take to Develop the Flu Vaccine? | The Weather Channel – Articles from The Weather Channel

A flu vaccine syringe rests on a table at a flu vaccination clinic Oct. 14, 2020, in Lakewood, California.

(Mario Tama/Getty Images)

• The first flu vaccine was licensed for civilian use in the U.S. in 1945.
• Dr. Jonas Salk was one of the lead researchers.
• Nearly 200 million doses of vaccine were expected to be manufactured this flu season.

The 1918 influenza pandemic infected an estimated 500 million people worldwide and left 675,000 people dead in the United States, according to the CDC.

But it wasn’t until 1945 – nearly three decades later – that the first flu vaccine was licensed for civilian use in the U.S.

In contrast, an effective and safe COVID-19 vaccine was developed in less than a year. Historically, vaccines have taken years to make it to distribution.

(MORE: Lyme Disease May Be Far More Prevalent Than Thought)

The first-ever vaccine to be developed was for smallpox in 1796, according to the World Health Organization.

Today, vaccines are available for more than two dozen diseases. Many of the shots, like those for measles and chickenpox, are considered routine.

Scientists dedicate their entire careers to researching vaccines. Dr. Jonas Salk, famous for creating the polio vaccine in the 1950s, was one of the lead researchers on the flu vaccine a decade earlier. Before Salk died at age 80 in 1995, he worked on a vaccine for HIV, which still hasn’t come to fruition.

Since Salk’s early work on the flu vaccine, it’s become one of the most common shots given.

Here’s a look back at some of the key moments in the history of influenza and the flu vaccine, based on a timeline from the U.S. Centers for Disease Control and Prevention:

–1933: Scientists isolate influenza A viruses, proving flu is not caused by bacteria.

–1936: The influenza B virus is isolated, and, separately, it was discovered that the flu virus can be grown in hen’s eggs.

–1942: A two-component vaccine is produced that offers protection against both influenza A and B viruses.

–1945: The first flu vaccine is licensed for civilian use in the U.S.

–1947: It’s discovered that flu viruses change from year to year and the vaccine will need to be adjusted annually to be effective.

–1957: A new flu pandemic emerges that kills more than 1 million people nationwide.

–1960: The U.S. surgeon general recommends annual flu shots for people with chronic debilitating diseases, anyone 65 years or older and pregnant women.

–1968: Another pandemic causes about 100,000 deaths in the U.S., mostly in people aged 65 and older.

–1976: An outbreak among Army recruits at Fort Dix, New Jersey, leads to a vaccination program that inoculates about 25% of the U.S. population in 10 months. But the program was halted due to cases of a neurologic condition called Guillain-Barre syndrome that in rare cases has been associated with vaccination. Today the CDC says that “If there is an increased risk of GBS following flu vaccination it is small, on the order of one to two additional GBS cases per million doses of flu vaccine administered.”

–2003: The first nasal spray flu vaccine is licensed for use.

–2008: The CDC’s Advisory Committee on Immunization Practices recommends children 5 to 18 years old be vaccinated against the flu each year. The move expanded a previous recommendation for younger children.

–2020-21: Nearly 200 million doses were expected to be distributed in the U.S. alone, and health officials urge everyone to get a flu vaccine to prevent the double threat of COVID-19 and the flu.

The Weather Company’s primary journalistic mission is to report on breaking weather news, the environment and the importance of science to our lives. This story does not necessarily represent the position of our parent company, IBM.

Flu vaccine turns 75 in 2020

While there is not yet an inoculation for the novel coronavirus (SARS-CoV-2) that causes COVID-19, effective seasonal influenza virus vaccines have been available for a full 75 years.

A global public health crisis has fast-tracked vaccine development for COVID-19 just as a pandemic more than a century ago brought the flu vaccine to fruition.

In 1918, about 500 million people, or one-fifth of the world’s population, became infected with the virus known as the “Spanish” flu, according to the Centers for Disease Control and Prevention (CDC). The estimated 50 million deaths worldwide included about 675,000 in the United States.

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“The 1918 Pandemic was the reason the military was so invested in getting a vaccine during World War II. They had seen what happened during World War I,” said Catherine Troisi, Ph. D., infectious disease epidemiologist and an associate professor at The University of Texas Health Science Center at Houston (UTHealth) School of Public Health.

Developing an influenza vaccine took more than a decade. Clinical trials began in the 1930s and researchers worked closely with U.S. military officials during World War II. In 1945, the first flu vaccine was approved for military use in the U.S. The following year, the vaccine was approved for civilians.

Influenza still causes widespread sickness and claims lives annually. During the 2018-2019 flu season, the CDC estimated that 35.5 million people in the United States were ill because of the virus, more than 490,000 were admitted to the hospitals and about 34,200 died.

The CDC ranges for the 2019-2020 flu season from Oct. 1, 2019 through April 4 fell between 39 million and 56 million illnesses, 410,000 and 740,000 hospitalizations and between 24,000 and 62,000 deaths from the flu.

(By comparison, the global toll of COVID-19—which emerged in China in late December 2019—has exceeded 16 million confirmed cases and more than 640,000 deaths, according to the World Health Organization. That count includes more than 4 million confirmed cases and more than 148,000 deaths in the United States.)

Also this week, a new analysis conducted by a team at UTHealth found that the influenza vaccine is tied to a lower risk of Alzheimer’s disease. The findings were presented during the Alzheimer’s Association International Conference 2020.

For the flu, annual vaccination is important because the viruses circulating will change from one season to the next.

“The reason you get vaccinated every year is twofold,” Troisi said. “The virus changes from year to year. Sometimes a little bit—that’s called the antigenic drift—and sometimes a lot, and that’s called antigenic shift.”

The last flu pandemic happened in 2009 with a novel influenza A virus known as h2N1 that contained “a unique combination of influenza genes not previously identified in animals or people,” according to the CDC.

“That was antigenic shift,” said Troisi, who earned her epidemiology doctorate from the University of Michigan, the same academic setting that produced the first flu vaccine. She also is a former assistant director of the Houston Health Department. “The reason we were so scared in 2009 is that we hadn’t seen h2N1 since 1918, so younger people didn’t have antibodies to it.”

Today, with COVID-19 continuing to spread, public health workers and government officials promoting prevention to curb transmission and medical workers hustling to treat patients, the influenza vaccine stands as a sturdy reminder that solutions can be found for deadly diseases if history remains our guide.

At least 150 COVID-19 vaccines are under development worldwide. Even with the most advanced in-human clinical trials, the rosiest projections have vaccines delivered by the end of the year. The U.S. government’s “Operation Warp Speed” aims for 300 million doses by January. So far, the U.S. Department of Health and Human Services has authorized $1.95 billion to engage Pfizer and biotech firm BioNTech for 100 million doses and another $1.6 billion with Novavax to accelerate 100 million doses. Both vaccines are likely to require two doses.

The enduring influenza vaccine with its annual updates can help shield people during the upcoming flu season. This will be important as the respiratory virus that causes COVID-19 will likely still be circulating.

The 75th anniversary of the influenza vaccine is an opportunity to recall the “forgotten flu epidemic” that befell the planet a century ago, said Syed Raza, M.D., chief medical officer and vice president of medical operations at CHI St. Luke’s Health-The Woodlands Hospital, CHI St. Luke’s Health-Lakeside Hospital and CHI St. Luke’s Health-Springwoods Village Hospital.

“It was something so catastrophic and we barely even talk about it. The only people that were protected, or that got better, were those who were getting blood from those who had previously been exposed to the flu,” he said. “That’s how they figured out that this vaccination thing might actually work. People who got these transfusions had antibodies to prevent the flu. ”

Similarly, convalescent plasma treatments via transfusions have been used to arm some COVID-19 patients with the antibodies their immune systems need to recover.

And while this new virus has caused a global health emergency, there hasn’t been a flu pandemic akin to 1918 since widespread flu vaccination began in 1945.

“That is despite the number of people on the planet tripling since then. If that’s not an indication that flu vaccine works, I don’t know what is,” Raza said. “The flu can kill you. The importance of the flu vaccine cannot be stressed enough.”

Health officials continue to strongly recommend annual flu vaccination—if for no other reason in 2020 than to mark 75 years of prevention.

“I think the best way to celebrate is to go out and get a flu shot,” said clinical pathologist S. Wesley Long, M.D., Ph.D., the medical director of Houston Methodist Hospital system’s diagnostic microbiology lab who also runs the organization’s online flu tracker.

FLU VACCINE TIMELINE

1918

An Influenza A strain jumps from birds to humans, creating a pandemic that kills an estimated 50 million people worldwide. More World War I soldiers died from flu than were killed in battle. The episode stimulates influenza research.

1930s

Researchers isolate Influenza A and start the first clinical trials of flu vaccines.

1938

The first flu vaccine is developed and given to soldiers during World War II.

1940

Influenza B viruses—the main cause of seasonal epidemics—are discovered.

1940s

University of Michigan researchers Thomas Francis Jr., M.D., and Jonas Salk, M.D., develop the first inactivated flu vaccine with support from the U.S. Army. The U.S. military placed a high priority on influenza vaccine development following the flu deaths of about 1 in every 67 soldiers during the 1918-1919 pandemic, which coincided with the end of World War I.

1945

The first influenza vaccine is approved for military use in the United States. The whole-virus, inactivated bivalent vaccine, which offered protection against Influenza A and Influenza B, had been tested on military recruits and college students.

1946

The flu vaccine is approved for civilian use.

Sources: Centers for Disease Control and Prevention (CDC), Journal of Preventive Medicine and Hygiene, National Vaccine Information Center

mRNA flu shots move into trials

Credit: PhotoDisc/GettyImages

Hot off the successful deployment of mRNA vaccines for the prevention of COVID-19, three leading drugmakers have moved seasonal flu vaccine candidates built with the technology into early clinical testing. More companies intend to follow their leads next year (Table 1).

These candidates, if successful, could dramatically bolster the efficacy of a vaccine class that often delivers lacklustre protection. For mRNA’s proponents — led by Moderna, Pfizer and Sanofi, all of which initiated phase I trials in recent months — new flu jabs could prove lucrative or help maintain standing in a global market projected to exceed US$10 billion by decade’s end.

But flu shots could also prove a more challenging test for mRNA than did COVID-19. That’s because unlike with SARS-CoV-2 — for which there were no established medical interventions — nine flu jabs from four different vaccine manufacturers are already available in the United States alone.

Those vaccines are safe, but their efficacy leaves room for improvement. Existing flu shots, whether built around inactivated viruses or recombinant proteins, typically offer only 40–60% protection from infection. In theory, mRNA might make for a better product: elicited immune responses may be broader, expressed proteins should have better sequence fidelity, strain selection may be more accurate and the technology makes it easy to incorporate large numbers of antigens. All of these features could translate into greater immune protection.

But mRNA, at least when formulated in lipid nanoparticles (LNPs), is prone to tolerability issues. Moderna and Pfizer/BioNTech’s authorized mRNA jabs for COVID-19 often cause sore arms, headaches, low-grade fevers and fatigue. These same symptoms can occur with approved flu shots, but typically are much milder in degree.

mRNA “is a tool that does offer some upside potential,” says Gary Nabel, former CSO of Sanofi, the founding director of the NIH’s Vaccine Research Center (VRC), and CEO of the stealth-stage immunotherapeutics company ModeX Therapeutics. “The big stumbling block is safety.”

To impact the established market, the platform would need to find a more tolerogenic sweet spot, as well as offer major efficacy advantages.

And yet, it’s no sure thing that mRNA will prove capable of effectively delivering haemagglutinin glycoproteins, the main antigen found in flu vaccines. “Did we just get really incredibly lucky with COVID vaccines because of the antigen design and the immunodominancy of that protein?” asks Anna Blakney, an RNA bioengineer at the University of British Columbia. “Or have we stumbled on something that’s functional for other viral glycoproteins as well?”

Making it

Many of the leading mRNA-based flu contenders were working on flu vaccine candidates before the pandemic. Then came the novel coronavirus, and “we literally swapped out flu coding sequences and swapped in SARS-CoV-2 sequences,” says Philip Dormitzer, head of viral vaccines research at Pfizer.

The whole field has benefited. Seqirus stayed out of the COVID-19 vaccine race, despite having a self-amplifying mRNA platform that delivers both the antigen-coding sequence and the replication machinery needed for the construct to copy itself inside the host cell. (Seqirus acquired that platform from Novartis in 2015.) “Seeing an mRNA vaccine functional and generating such a robust response has somewhat derisked the outside concerns that people may have had around the general technology,” says Ethan Settembre, vice president of R&D at Seqirus.

And the potential benefits of mRNA for flu prophylaxis are many.

Some of these boil down to how the vaccines get made. Because mRNA vaccines are manufactured synthetically, by encoding a target antigen sequence into a plasmid template, they offer high fidelity: encoded antigens exactly match the flu strains selected for each year’s vaccine. By contrast, inactivated virus vaccines that are made in egg- and cell-based systems often suffer from sequence mutations that weaken their effectiveness.

Recombinant protein vaccines offer that same fidelity advantage, but the manufacturing process for these is comparatively cumbersome. The flexibility and speed of mRNA vaccine production mean that vaccine makers could wait longer to begin manufacturing — starting production in May, say, instead of February, for the northern hemisphere. This would enable them to make more informed decisions about what strains to include.

“Every bit of time helps,” says Sally Mossman, head of GlaxoSmithKline’s Vaccine R&D centre in the United States.

Enter the multiplex

There may be other efficacy benefits. The US relies on quadrivalent vaccines, containing haemagglutinin antigens (either purified from inactivated viruses or manufactured recombinantly) or live attenuated viruses that confer protection against four strains of influenza. (Other jurisdictions still use trivalent vaccines.) Some researchers have argued in favour of adding protection against additional strains, but doing so is logistically challenging with existing platforms.

Not necessarily so with mRNA.

A team led by Norbert Pardi, from the University of Pennsylvania Perelman School of Medicine, and Raffael Nachbagauer, then at the Icahn School of Medicine at Mount Sinai, showed as much last year. They immunized mice against one subtype of influenza with an mRNA vaccine encoding four different proteins: haemagglutinin stalk, neuraminidase, matrix-2 ion channel and nucleoprotein. Together with Mount Sinai’s Meagan McMahon, Pardi and his colleagues have since repeated the exercise for two other flu subtypes. They plan to test a combined vaccine containing 10–12 antigens in mice and ferrets. Ideally, this will induce such broad immune protection that it doesn’t need to be taken every year.

Many researchers also hope that mRNA will spur stronger or more diverse immune responses than traditional platforms. If true, this could prove especially beneficial for older adults, who often have weak responses to flu vaccines, notes Jenna Bartley, who studies immunological aging at the University of Connecticut School of Medicine.

It could even aid in the development of a universal flu vaccine that protects against all strains of the virus, says Duke University’s Tony Moody. With NIH backing, he is now developing an mRNA-based haemagglutinin stabilized-stem vaccine, modelled after a protein-based one that is already in the clinic. “It’s an informative experiment,” says VRC director John Mascola. “We don’t know how to induce a high level of durable antibodies to stem, and mRNA may be different in the way that it induces that response.”

Current vaccine technologies mostly elicit only humoural responses that block viral invasion. mRNA vaccines, because they somewhat mimic natural infections, may bring about better T-cell responses.

Barney Graham also sees a broader societal opportunity: by working on seasonal mRNA candidates today, companies should be better prepared to tackle flu pandemics in the future. “That is the place mRNA could really change the deal,” says Graham, who retired as deputy director of the VRC at the end of August. “If we really did have a pandemic, you could design [a new vaccine] within 10 minutes after you got the sequence, and you could have mRNA going into arms within a few weeks.”

Show me the data

The only human data reported to date on an mRNA-based flu vaccine come from Moderna’s first foray into the clinic. Beginning in late 2015, the company evaluated a pair of two-dose vaccines, each designed against a different strain of avian influenza.

According to former Moderna CMO Tal Zaks, the main goal of those trials was to give the company’s mRNA a test run. “If you want to show that the technology works, the easiest place to start is with an influenza vaccine,” he says. With influenza, he explains, the correlates of protection — measurements of immune parameters that allow prediction of vaccine efficacy — are well defined. There are also established vaccines to reference clinical results to.

To many onlookers, Moderna’s first trials were a disappointment. Although most study participants who received higher doses of the experimental vaccines developed influenza-specific antibody titres above the threshold thought to be protective — as measured by the well-validated haemagglutination inhibition (HAI) assay — those antibody levels tapered off within just months of immunization. This suggests that the protection these offer might be short-lived. T-cell immunity was not detectable at all.

Former company executives involved in the trials see things differently. Both Giuseppe Ciaramella, ex-head of infectious diseases research, and Michael Watson, former president of Moderna’s vaccines unit, argue that the vaccines induced a robust pool of memory B cells, which remember antigens and can trigger rapid production of antibodies when people are re-exposed to the virus.

They highlight data from 5 participants who received their two shots 6 months apart, instead of 3 weeks apart like everyone else. Those individuals achieved much higher average HAI titres — “evidence,” says Watson, “that the first dose had primed really well.” Watson is now executive chairman of VaxEquity and chief executive of MEVOX, neither of which is working on influenza.

Watson is less sanguine about the tolerability findings, though. Although Moderna has since changed its LNP formulation and aspects of its mRNA design, its early trial data suggested that the therapeutic index for an mRNA-based flu vaccine might be narrow. This could prove problematic for a multi-component seasonal flu shots designed to train the immune system to recognize at least four antigens.

Moderna is nevertheless forging ahead clinically — and it has already begun adding additional antigens to its next generation of flu products. Neuraminidase, another surface glycoprotein, will be included in the company’s follow-on clinical candidates. Other antigens that might better stimulate T-cell immunity are under consideration as well. Plus, the company is preparing combination vaccine candidates that could protect against multiple respiratory viruses. One of these, for COVID-19 and flu, is due to enter clinical testing next year.

But the addition of antigenic targets will likely necessitate higher total vaccine doses, points out Watson, potentially triggering more severe adverse reactions. “That’s definitely the yin and the yang there,” he says.

Open season

Nachbagauer, who joined Moderna last year to lead infectious disease R&D efforts, is mindful of the tolerability concerns, but he is taking a wait-and-see approach to the problem. The company’s first seasonal flu vaccine candidate, mRNA-1010, consists of four mRNA sequences encoding haemagglutinin glycoproteins from the viral lineages recommended by global health authorities, formulated in the same LNPs used to deliver the company’s COVID-19 vaccine. “We’re really interested in what our reactogenicity looks like,” he says.

The immunological contexts around pandemic and seasonal flu vaccines are quite different, adds Nachbagauer. Pandemic flu vaccines have to protect against a novel threat. Because people generally do not have pre-existing immunity to these, a two-dose, prime-boost immunization regimen is key. With the seasonal flu, most people have been exposed to the related strains or received earlier flu jabs. Just one shot can therefore be enough to protect against the latest adaptation of a continuously mutating adversary. If the COVID-19 vaccines are any guide, a one-dose candidate could prove more tolerable than a two-dose product.

Moderna launched a 180-person, dose-ranging trial of mRNA-1010 in July. It is expected to run through early 2022.

Sanofi and Pfizer have also moved their first mRNA-based flu shots into phase I testing. These companies are taking measured approaches to derisking mRNA platforms, starting with candidates containing just a single mRNA encoding the haemagglutination head domain from one type of influenza virus.

Sanofi is evaluating its monovalent h4N2 vaccine candidate in two different LNP formulations. “If results are positive, clinical development of a quadrivalent flu vaccine would be the next step,” says Frank DeRosa, chief technology officer of Sanofi subsidiary Translate Bio. (Sanofi acquired Translate earlier this year for $3.2 billion.)

The company’s flu vaccine, for now, uses a form of mRNA that lacks the chemical modifications found in most other mRNA products. Sanofi’s COVID-19 vaccine, built around this unmodified mRNA platform, successfully elicited antibody responses in early clinical testing. But it remains unproven in an efficacy trial. CureVac’s unmodified mRNA COVID-19 vaccine stumbled in phase III trials, however, raising the possibility that this strategy may prove inferior to modified mRNA candidates.

That perhaps explains why Sanofi is planning to also have a quadrivalent flu vaccine, based on modified mRNA, in the clinic by next year. CureVac, in partnership with GlaxoSmithKline, is considering both mRNA options for its flu jab.

Meanwhile, Pfizer is moving ahead with two parallel programmes: one involving modified mRNA, and the other with a self-amplifying construct. Its modified mRNA candidate, PF-07252220, is first up. (Pfizer has licensed BioNTech’s technology, and has elected to advance its flu programme solo.) In September, it began a phase I trial of this monovalent vaccine at four dose levels, each shot containing a single antigen from either a type A or B influenza strain. It plans to later combine those into a bivalent vaccine, administered at different dosages, before moving onto a quadrivalent product — all benchmarked against an approved flu shot.

Pfizer plans to begin trials of its self-amplifying mRNA candidate in the coming months, too.

A path well trodden

For any mRNA-based vaccine that advances into later-stage testing, the regulatory pathway to approval is well defined: companies will either need to demonstrate efficacy through classical clinical trials or show non-inferiority against a licensed comparator on a surrogate measure of protection, such as HAI titre. “That’s the beauty about flu,” says Pad Chivukula, chief scientific officer and chief operating officer of Arcturus Therapeutics. “The path for licensure is pretty straightforward.”

The correlate approach is lower cost and involves less risk, especially for vaccines optimized to induce antibody production. But it won’t capture protection accrued through induction of T-cell responses or other arms of the immune system, a potential downfall for mRNA contenders. The correlate approach also won’t support claims about the superiority of the platform when it comes to the breadth or longevity of protection. So most companies with mRNA-based vaccines in the works anticipate eventually running large-scale trials over one or more flu seasons.

“Ultimately,” says Dormitzer, “I think for people to really be convinced to switch to a new vaccine platform, they’re going to want to see efficacy as well as all the immunological comparisons.”

Although last year saw a sharp drop in flu cases around the world, likely the result of mask-wearing and social-distancing in response to COVID-19, most experts expect influenza to come storming back. When it does, companies hope their mRNA-based vaccine candidates will be ready.

Types of seasonal influenza vaccine

Two types of influenza vaccine are widely available: inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIV). Traditionally, influenza vaccines (both IIV and LAIV) have been produced to protect against 3 different seasonal influenza viruses (also called trivalent vaccines). In most countries this is still the case and the current trivalent vaccines contain influenza A(h4N2), pandemic A(h2N1) and 1 of 2 influenza B lineage viruses. However, recently vaccines which protect against 4 different viruses, including both influenza B lineage viruses (quadrivalent vaccines), have become available in some countries.

Regardless of the type or composition of seasonal influenza vaccine, vaccination should be administered annually to provide optimal protection against infection.

Annual selection of viruses

The composition of influenza vaccines (both IIV and LAIV) are updated annually by WHO based on information gathered from the Global Influenza Surveillance and Response System (GISRS), a partnership of 141 national influenza centres in 111 countries, 6 WHO collaborating centres and 4 WHO essential regulatory laboratories.

The WHO GISRS collects and analyses influenza virus samples from around the world on an ongoing basis. Each year, 1 or more components of the vaccine designated for the coming influenza season in the northern and/or southern hemisphere might be changed to reflect the most frequent and recent circulating influenza A and B viruses.

Production

Since vaccine production takes about 6 months, each year the influenza vaccine is produced under great time pressure requiring timely submission of viruses to the WHO GISRS. The production of seasonal influenza vaccines is based on viral propagation in embryonated eggs or cell cultures.

Inactivated influenza vaccines (IIV)

IIV is approved for use in persons 6 months and older, including pregnant women and persons with chronic medical conditions.  One dose, injected into the deltoid thigh or muscle, is recommended. However, children aged 6 months to 8 years who have not received seasonal influenza vaccine during the previous influenza season should receive 2 doses administered at least 4 weeks apart. Influenza vaccination in pregnancy will protect both the mother and her newborn against influenza.

The viruses included in these vaccines are inactivated so they do not cause influenza, although minor side effects may occur including local reactions at the injection site. Persons without previous exposure to influenza vaccine antigens may experience transient fever, malaise, myalgia (muscle pain) and other systemic adverse events. 

Live attenuated influenza vaccines (LAIV)

LAIV is approved for use only in persons aged 2–49 years who do not have underlying medical conditions. The vaccine should, however, not be administered to pregnant women. LAIV is given as a nasal spray, 1 dose only; but children aged 2–8 years who have not received seasonal influenza vaccine during the previous influenza season should receive 2 doses, at least 4 weeks apart. 

LAIV is made from attenuated, or weakened, viruses and does not cause influenza, although it can cause mild signs or symptoms (including rhinorrhoea, nasal congestion, fever or sore throat). Most common side effects from the vaccine are mild and transient compared to symptoms of influenza infection.

Inactivated Influenza (Flu) Vaccine | HealthLinkBC File 12d

What is the inactivated influenza vaccine?

The inactivated influenza vaccine is made of killed influenza viruses. It protects against viruses that cause influenza, often called the flu. The vaccine does not protect against other viruses or bacteria that cause colds or stomach flu. Several different influenza vaccines are available in B.C., including a live attenuated influenza vaccine made from weakened influenza viruses. For more information, see HealthLinkBC File #12e Live Attenuated Influenza (Flu) Vaccine. All of the vaccines are approved by Health Canada.

In B.C., influenza vaccines are usually available in October. For your best protection, get immunized as soon as possible. Speak with your health care provider to find out when the vaccines are available or visit ImmunizeBC https://immunizebc.ca/clinics/flu to locate a flu clinic.

Who should get the vaccine?

In 2021, the inactivated influenza vaccine is free for everyone in B.C. older than 6 months.

How is the vaccine given?

The vaccine is given by injection, usually as 1 dose. Children under 9 years of age who have never had a seasonal influenza vaccine need 2 doses. The second dose of vaccine is important to raise their level of protection and should be given 4 weeks after the first dose.

What are the benefits of getting the vaccine?

The vaccine is the best way to protect against influenza, a serious and sometimes fatal infection. When you get immunized, you help protect others as well by reducing the spread of the influenza virus. 

What are the possible reactions after the vaccine?

Common reactions to the vaccine include soreness, redness and swelling where the vaccine was given. Other symptoms, that may last 1 to 2 days, can include fever, headache, muscle soreness, fatigue, nausea, vomiting, diarrhea and chills. Babies and young children may be irritable, sleepy and have a decreased appetite. Fewer than 1 in 20 people may have oculo-respiratory syndrome (ORS). Symptoms of ORS include red eyes, a cough and/or sore throat and/or hoarseness.

You cannot get the flu from the inactivated influenza vaccine because it contains killed influenza viruses that cannot cause infection.

Acetaminophen (e.g. Tylenol^®) or ibuprofen* (e.g. Advil^®) can be given for fever or soreness. ASA (e.g. Aspirin^®) should not be given to anyone under 18 years of age due to the risk of Reye Syndrome.

For more information on Reye Syndrome, see HealthLinkBC File #84 Reye Syndrome.

It is important to stay in the clinic for 15 minutes after getting any vaccine because there is an extremely rare possibility, less than 1 in a million, of a life-threatening allergic reaction called anaphylaxis. This may include hives, difficulty breathing, or swelling of the throat, tongue or lips. Should this reaction occur, your health care provider is prepared to treat it. Emergency treatment includes administration of epinephrine (adrenaline) and transfer by ambulance to the nearest emergency department. If symptoms develop after you leave the clinic, call 9-1-1 or the local emergency number.

It is important to always report serious or unexpected reactions to your health care provider.

Guillain-Barré Syndrome (GBS) is a rare condition that can result in weakness and paralysis of the body’s muscles. It most commonly occurs after infections. In rare cases GBS can also occur after some vaccines. GBS may be associated with influenza vaccine in about 1 per million recipients.

Who should not get the inactivated influenza vaccine?

Speak with your health care provider if you:

• Had a life-threatening reaction to a previous dose of influenza vaccine, or any part of the vaccine (people with egg allergies can be safely immunized)
• Had severe oculo-respiratory syndrome after a previous flu shot
• Developed Guillain-Barré Syndrome (GBS) within 8 weeks of getting any influenza vaccine without another cause being identified
• Are receiving a checkpoint inhibitor to treat cancer. This may affect when you should get the vaccine

Children less than 6 months of age should not get the vaccine because it is not known to be effective at this age.

There is no need to delay getting immunized because of a cold or other mild illness. However, if you have concerns speak with your health care provider.

What is influenza?

Influenza is an infection of the upper airway caused by the influenza virus. A person with influenza is at risk of other infections, including viral or bacterial pneumonia which is an infection of the lungs.

Influenza spreads easily from person-to-person through coughing, sneezing or face-to-face contact. The virus can also spread when a person touches tiny droplets from a cough or sneeze on another person or object and then touches their eyes, mouth or nose before washing their hands.

What is the Influenza Prevention Policy?

B.C. has an Influenza Prevention Policy to protect high risk people from influenza. Health care workers are required to be immunized against influenza or wear a mask when they are in patient care areas during the influenza season. Students, volunteers and visitors to health care facilities and other patient care locations are also expected to wear a mask if they did not get an influenza vaccine.

Mature Minor Consent

It is recommended that parents or guardians and their children discuss consent for immunization. Children under the age of 19, who are able to understand the benefits and possible reactions for each vaccine and the risk of not getting immunized, can legally consent to or refuse immunizations. For more information on mature minor consent see HealthLinkBC File #119 The Infants Act, Mature Minor Consent and Immunization.

For More Information

For more information, see the following HeathLinkBC Files:

For more information on immunizations visit ImmunizeBC at https://immunizebc.ca/.

How Covid Vaccine Technology Could Improve Flu Vaccines

As the world grapples with Covid-19, influenza isn’t getting much attention these days. But the flu’s global impact is staggering: three million to five million cases of severe illness every year, and up to 650,000 deaths. Every few decades, a new flu strain spills over from animals and leads to a pandemic.

The deadly toll of influenza is all the more striking when you consider that we have had vaccines to fight it for eight decades. But they remain mediocre. A flu shot is good for only one flu season, and its effectiveness typically reaches somewhere between 40 and 60 percent. In some years it’s as low as 10 percent.

But a new generation of highly effective flu vaccines may emerge in the next few years, based on the same mRNA technology that has protected hundreds of millions of people against Covid-19.

While traditional influenza vaccines are grown for months in chicken eggs, mRNA vaccines are manufactured relatively quickly from scratch. In theory, their faster production may make them better matched to each season’s flu strains. And when they’re injected into people, they may provoke a stronger immune response than traditional flu vaccines do.

Two companies — Moderna, the Massachusetts biotech company that produced one of the authorized mRNA vaccines for Covid-19, and Sanofi, a French vaccine maker — began trials for mRNA flu vaccines this summer. Pfizer and BioNTech, the companies that produced the other mRNA Covid-19 vaccine, started their own flu trial last month. And Seqirus, a vaccine producer based in England, is planning to test another mRNA vaccine for the flu early next year.

No one can say for sure how well any of these four seasonal flu vaccines will turn out, but many experts are optimistic. And further down the line, mRNA technology may be tailored to make vaccines that work for years against a wide range of influenza strains.

“I am beyond excited for the future of flu vaccination,” said Jenna Bartley, an immunologist at the University of Connecticut.

Not good enough

The 1918 influenza pandemic was the worst in modern history, killing somewhere between 50 million and 100 million people. As the death toll climbed, doctors responded by inoculating people by the thousands with an assortment of experimental vaccines. None of them worked.

Scientists at the time wrongly believed that disease was caused by bacteria, not viruses. That error led them to make vaccines from the microbes they gathered in the sputum of flu patients. The vaccines were useless at mounting an immune defense against the viral disease.

It was not until 1933 that British virologists isolated the influenza virus, finally making it possible to design an effective vaccine. Researchers injected influenza viruses into chicken eggs, where they multiplied. Once they had extracted and purified the new viruses, they killed them with chemicals, and injected the inactivated viruses into people.

The United States licensed the first commercial influenza vaccine in 1945. The Nobel-prize-winning virologist Wendell Stanley hailed the milestone, declaring that the vaccine would prevent influenza from ever again becoming “one of the great destroyers of human life.”

But the vaccine didn’t quite live up to Dr. Stanley’s hopes. Influenza outfoxed it with an awesome power to mutate.

During an influenza infection, cells in our airway begin copying the virus’s genome, allowing it to proliferate. The copying process results in lots of genetic errors. Sometimes these mutations will enable the virus to escape the body’s immune response spurred by a vaccine.

Flu viruses also have another route to rapid evolution. If two types of flu viruses infect the same cell, it can produce a genetic hybrid, which may evade vaccine-triggered immunity even more successfully.

This extraordinary capacity for change also explains why several strains of flu may circulate in a single flu season, and new strains may rise to dominance the following year.

“The flu virus, for lack of a better word, is just kind of a jerk,” Dr. Bartley said.

Vaccine makers have responded by including up to four different strains in their annual formulations. But because producing vaccines in chicken eggs is such a slow process, scientists must choose which strains to include several months before a flu season, often leading to a mismatch when the shape-shifting virus actually arrives.

“It’s an educated guessing game,” said Dr. Alicia Widge, an immunologist at the National Institutes of Health’s Vaccine Research Center. “We’re always catching up with the virus.”

Between 2004 and 2019, the effectiveness of the flu vaccine ranged from as high as 60 percent to as low as 10 percent. Even that modest protection translates into a lot of benefit, however, because so many people get the flu every year. In addition to lowering the odds of getting infected, the vaccine also lowers the chances that people sick with the flu have to go to the hospital.

In the 2018-19 flu season, the flu vaccine — with an effectiveness of just 29 percent — prevented an estimated 4.4 million illnesses in the United States alone, plus 58,000 hospitalizations and 3,500 deaths, according to one study.

Updated 

Nov. 3, 2021, 6:27 p.m. ET

If scientists could make more robust flu vaccines, they could potentially save thousands of additional lives.

“The bottom line is that the flu vaccines we have aren’t good enough,” said Nicholas Heaton, a virologist at Duke University School of Medicine.

Immune factories

In the 1990s, a few researchers set out on an entirely new course, making flu vaccines from mRNA.

The idea behind the technology was radically different than the chicken-egg approach. In effect, the new shots would turn people’s own cells into vaccine factories.

Scientists would create an mRNA molecule with the instructions for making an influenza protein, then deliver it into cells. Those cells would then make copies of the viral protein, some of which would end up on their surface. Immune cells passing by would detect the alien proteins and respond with a defense against the virus.

In 1993, a team of French scientists conducted the first experiments on an mRNA vaccine for the flu. The vaccines produced promising responses in mice, but were still primitive. For one thing, the animal’s cells sometimes responded to the vaccine’s mRNA by destroying it, as if it belonged to a foreign enemy. It took more than two decades of additional lab work before mRNA vaccines were ready for human trials.

When Moderna formed in 2010 to bring mRNA vaccines to the clinic, influenza was one of the first diseases it tackled. The company started with vaccines for two flu strains that normally infected birds but sometimes sickened people — exactly the kind of viruses that might give rise to new pandemics.

Their first clinical trial results, in 2016, were encouraging. The volunteers produced antibodies against the viruses, though they also had side effects like fever and fatigue. The results spurred Moderna to build a new factory in Norwood, Mass., where the company could make large quantities of mRNA for more clinical trials.

The company began developing a new flu vaccine, this one for seasonal influenza rather than for pandemics. And the researchers worked on making the side effects of the vaccine less severe.

“You want folks to feel comfortable strolling into CVS and getting their shot, and not be worried about adverse events,” said Rose Loughlin, vice president for research and development strategy at Moderna.

But then in early 2020, just as they were hoping to begin a new flu trial, the scientists had to shelve the plan. A new coronavirus was exploding in China.

Combo shots

Over the next year, Moderna made and tested a Covid mRNA vaccine in record speed. And its shot, like that of its primary competitor, Pfizer-BioNTech, was remarkably protective, with an efficacy rate around 95 percent.

The success of mRNA vaccines delivered huge revenues to both companies. The Pfizer-BioNTech vaccine is on track to become the best-selling medicine of all time. And Moderna’s market cap since the beginning of the pandemic increased 19-fold to around $123 billion.

Riding the mRNA wave, these companies, along with Sanofi and Seqirus, are moving on to seasonal flu projects.

Jean-François Toussaint, Sanofi Pasteur’s head of global research and development, cautioned that the success of mRNA vaccines against Covid did not guarantee similar results for influenza.

“We need to be humble,” he said. “The data will tell us if it works.”

But some studies suggest that mRNA vaccines might prove more potent than traditional ones. In animal studies, mRNA vaccines seem to provide a broader defense against influenza viruses. They prompt the animals’ immune systems to make antibodies against the virus, and also train immune cells to attack infected cells.

But perhaps most important for the flu, mRNA vaccines can be made rapidly. The speed of mRNA manufacturing may allow vaccine makers to wait a few extra months before picking which influenza strains to use, potentially leading to a better match.

“If you could guarantee 80 percent every year, I think that would be a major public health benefit,” said Dr. Philip Dormitzer, Pfizer’s chief scientific officer.

The technology also makes it easier for mRNA vaccine makers to create combination shots. Along with mRNA molecules for different strains of influenza, they can also add mRNA molecules for entirely different respiratory diseases.

At a Sept. 9 presentation for investors, Moderna shared results from a new experiment in which researchers gave mice vaccines combining mRNAs for three respiratory viruses: seasonal flu, Covid-19 and a common pathogen called respiratory syncytial virus, or RSV. The mice produced high levels of antibodies against all three viruses.

Other researchers have been searching for a universal flu vaccine that could protect people for many years by fending off a broad range of influenza strains. Rather than an annual shot, people might need only a booster every few years. In the best-case scenario, one vaccination might even work for a lifetime.

At the University of Pennsylvania, a team of researchers led by Norbert Pardi is developing mRNA vaccines that encode proteins from influenza viruses that mutate only rarely. Experiments in animals hint that these vaccines could remain effective from year to year.

Although Moderna isn’t working on a universal flu vaccine at the moment, “it’s absolutely something we’d be interested in for the future,” said Dr. Jacqueline Miller, the company’s head of infectious disease research.

Even if mRNA flu vaccines live up to expectations, they will probably need a few years to gain approval. Trials for mRNA flu vaccines won’t get the tremendous government support that Covid-19 vaccines did. Nor will regulators be allowing them to get emergency authorization. Seasonal flu is hardly a new threat, and it can already be countered with licensed vaccines.

So the manufacturers will have to take the longer path to full approval. If the early clinical trials turn out well, vaccine makers will then have to move on to large-scale trials that may need to stretch through several flu seasons.

“It should work,” said Dr. Bartley of the University of Connecticut. “But obviously that’s why we do research — to make sure ‘should’ and ‘does’ are the same thing.”

Why flu vaccines so often fail | Science

The influenza virus has yet to hit the Northern Hemisphere, but flu vaccine season is already in full swing, with banners outside pharmacies urging: “Get Your Flu Shot Now.” What’s not advertised, however, is just how lackluster the vaccine is. The most commonly used flu shots protect no more than 60% of people who receive them; some years, effectiveness plunges to as low as 10%. Given that a bad flu season can kill 50,000 people in the United States alone, “10% to 60% protection is better than nothing,” says Michael Osterholm, an epidemiologist at the University of Minnesota in Minneapolis. “But it’s a terribly inadequate vaccine for a serious public health threat.” Now, researchers are striving to understand why it fails so often—and how to make a markedly better one.

They’re questioning what was once received wisdom: that the vaccine fails when manufacturers, working months ahead of flu season, incorrectly guess which strains will end up spreading. And they’re learning instead that the vaccine may falter even when the right strains were used to make it, perhaps because of how it is produced or quirks of individual immune systems. “It’s much more complicated than we thought,” Osterholm says. “I know less about influenza today than I did 10 years ago.”

The influenza vaccine teaches the body to produce antibodies against the head of the virus’s surface protein, hemagglutinin (HA). Those antibodies ideally prevent HA from attaching to cellular receptors, thwarting infection. But HA’s head is highly mutable, which is why vaccinemakers must come up with a new formula every year.

For many decades, researchers believed the flu vaccine offered solid protection if it was a good match to the circulating strains; studies from the 1940s through the 1960s routinely showed an efficacy of 70% to 90%. But those studies relied on a misleading methodology. Without a simple way to detect the virus in the blood, researchers measured antibody levels, looking for a spike that occurs after infection. Then in the 1990s, sensitive polymerase chain reaction tests enabled researchers to actually measure viral levels, and they told a different story. It turned out that some people who did not have the big antibody spike after exposure—and were therefore counted as a vaccine success—actually did show a jump in viral levels, signaling infection. Earlier assessments had exaggerated vaccine efficacy. What’s more, efficacy was sometimes low even when the vaccine and circulating strains appeared well matched. Something else was afoot.

Loss of confidence

For decades, tests suggested the flu vaccine worked extremely well, but in the past 15 years a better test revealed many infections in vaccinated people who would previously have been deemed protected.CREDITS: (GRAPHIC) G. GRULLÓN/SCIENCE; (DATA) F. M. DAVENPORT ET AL. MED J AUST. 1973; SUPPL 33-38; CENTERS FOR DISEASE CONTROL & PREVENTION

The circulating strains continue to mutate after the vaccine is made, and the resulting “escape mutants” are often blamed for vaccine failure. But Arnold Monto, an epidemiologist at the University of Michigan School of Public Health in Ann Arbor, is skeptical that escape mutants play a major role. In a preprint published 15 August on bioRxiv, his team reports sequencing influenza DNA from 249 viral specimens collected from people over five influenza seasons. They found loads of HA mutations, as expected, but most weakened the virus, making it “unfit,” meaning it could not transmit human to human. Viable escape mutants, Monto concludes, are too rare to explain the failures seen year after year.

Danuta Skowronski, an epidemiologist at the BC Centre for Disease Control in Vancouver, Canada, instead blames mutations in the vaccine strain itself. The most common influenza vaccine contains an “inactivated” virus, which manufacturers grow in chicken eggs. As Skowronski’s team first reported in 2014, the virus can mutate while it is growing in the eggs, resulting in a vaccine unable to block circulating strains.

“I think [these mutations] play an enormous role,” says viral immunologist Scott Hensley of the University of Pennsylvania. He has preliminary evidence that egg-adapted mutations were behind the weak protection seen with the vaccine used in the 2016–17 season, he says. He also points to a recent study by another group that compared an egg-grown vaccine with one that contained genetically engineered HA, which sidesteps the mutation issue. The engineered vaccine offered more solid protection. That suggests a way to improve current vaccines, Hensley says. “I’d be shocked in 15 years if any of our flu vaccines are grown in eggs.”

When flu virus is grown in eggs to make the vaccine, mutations can occur in key places (red) on the viral surface protein hemagglutinin, which undermine the shot’s protective powers.

ADAPTED FROM D. SKOWRONSKI ET AL. PLOS ONE 9, 3 (25 MARCH 2014) © PLOS

Hensley notes another way to reduce the odds of failure: improving the techniques for choosing the vaccine strains. Vaccinemakers largely rely on an old technique that exposes ferrets—which differ from humans—to candidate vaccine strains and then assesses whether they can stop viral isolates from people naturally infected with the circulating strains. Genetic comparisons, he says, would yield a better match.

Understanding the immune responses that correlate with protection could also help refine vaccines. Immune responses to targets other than HA’s head, including HA’s stem and a second viral surface protein, neuraminidase, receive scant attention. Further complicating the picture is the immunologic legacy of multiple exposures to influenza each year—from the vaccine and from wild-type virus. “What is the effect of primary and subsequent exposure to the virus?” asks Adolfo García-Sastre, an influenza vaccine researcher at the Icahn School of Medicine at Mount Sinai in New York City. “It makes it very difficult to come up with hard data about what’s going on.”

Hensley’s group has shown that the immune system is also biased by a child’s first exposure to flu, which leaves a ghost that affects responses to subsequent vaccines. This may explain why middle-aged people in 2013–14 were unusually hard-hit by a viral mutant that did not infect most vaccinated people, his team has reported. The team’s studies showed that in this age group, the vaccine elicited antibodies to a similar—but not identical—HA they had seen as kids, and the resultant immune response missed the target. “These first exposures really shape how we respond our entire lives,” Hensley says. Immunologist Rafi Ahmed at Emory University in Atlanta last year reported that long-lived memory B cells to flu, which produce antibodies, can crowd out B cells that would otherwise respond to novel infections.

Other evidence suggests that repeated vaccinations can blunt the immune response to some HAs. “We don’t understand enough about the effects … to make any recommendations right now,” says Edward Belongia, an epidemiologist at the Marshfield Clinic Research Institute in Wisconsin, who led a recent meta-analysis. “The best strategy remains to get a vaccine every year.” This is especially true for the elderly or immune-compromised people: Even if a vaccine fails to prevent infection, they may suffer less severe disease if immunized.

The BC Centre’s Skowronski says many influenza researchers are hesitant to discuss problems with the vaccine “because they’re afraid of being tainted with the antivaccine brush.”

She says that’s a mistake. “This immunization program has been predicated on assumptions on top of assumptions. Unless we have these discussions, we’ll never have improved vaccine options. And I don’t think it’s antivaccine to want your vaccine program to be the best that it can be,” she adds.

Skowronski thinks the field must more aggressively pursue a universal influenza vaccine that would work against many strains and last for years. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, agrees. He wants to accelerate that work by creating a new consortium of top researchers, which he hopes next year’s budget can fund. “I’m going to make universal influenza vaccine my top priority over the next couple years,” Fauci says. “We’ve got to do better.”

90,000 “Made from wheels.” The scientist compared influenza and COVID-19 vaccines

https://ria.ru/20210422/vaktsinatsiya-1729224470.html

“Made from wheels.” The scientist compared influenza and COVID-19 vaccines

“Made from wheels.” Scientist compared influenza and COVID-19 vaccines The scientist compared influenza and COVID-19 vaccines

According to Oxford statistics, at the moment, about seven percent of the population in Russia has been vaccinated against coronavirus.For comparison: last year’s influenza RIA Novosti, 22.04.2021

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science

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gennady Onishchenko

health

biology

covid-19 coronavirus

satellite v vaccine

epivaccoron vaccine

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MOSCOW, 22 Apr – RIA Novosti, Tatyana Pichugina. According to Oxford statistics, about seven percent of the population has been vaccinated against coronavirus in Russia at the moment. By comparison, 53 percent of people, nearly 70 million people, including risk groups, were vaccinated against the flu last year. What is the difference between these vaccines, is it possible to combine them and how inactivated drugs are made, Doctor of Biological Sciences Andrei Vasin, Acting Director, Professor of the Institute of Biomedical Systems and Biotechnology of Peter the Great St. Petersburg Polytechnic University told RIA Novosti.- Andrei Vladimirovich, in addition to the coronavirus, the elderly are being vaccinated en masse only against the flu. Is it effective? – Yes. Although it is believed that the vaccination efficiency of the older generation is lower than that of the younger generation. If this is revealed during clinical or post-registration studies, the drug for the elderly can be modified, for example, by increasing the antigen content in the dose. In reality, the immune response is very individual and does not always depend on age. – Did the mass flu vaccination lead to the fact that people became less ill? – Certainly.In Russia, the coverage of the population with influenza vaccination is probably the largest in the world. As a result, fewer hospitalizations for this infection, as well as the risk of severe complications and death, including among the elderly. This should also be true for covid, which is most difficult for those over 60. — Gennady Onishchenko said that 70 million people were vaccinated against the flu last year in Russia. That is, more than half of the population. Why then is the vaccination against COVID-19 stalled? – Let’s proceed from the fact that vaccinations against this infection are just emerging, everything is done on the fly.It is not easy to make 140 million doses of a new vaccine. Nevertheless, it is enough. Virologists, doctors see no signs that these drugs are working poorly or cause serious side effects. I don’t see that either. Perhaps people need to be more clarified that the risk of serious complications, death with COVID-19 is incomparably greater than the likelihood of side effects from vaccination. – Since everything is so well established with influenza, it would be logical to combine this vaccine with coronavirus. – It will not work – drugs are based on different principles.Others need to be developed. This is being done at the Smorodintsev Research Institute of Influenza and the Institute of Experimental Medicine, both in St. Petersburg. They use the influenza virus as a carrier vector for the coronavirus antigen. But these vaccines will be ready at best next year. “Then maybe introduce a lockdown?” Self-isolate, maintain social distance, use protective equipment and wait for the end of the pandemic or the formation of herd immunity. – Herd immunity consists of natural, obtained from infection, and artificial, stimulated by the vaccine.As far as I know, we are not yet close to the required indicators. Who is able to afford such a long self-isolation, even among unemployed pensioners? And how much more stay at home – six months, a year? Since the main risk group is the elderly, vaccination is the only correct way out for them. It is necessary to limit the spread of infection. The situation in Russia is better than in other countries. But it should be remembered that the pandemic is not over yet. – According to phase III trials, the protective effectiveness of Sputnik V is even higher in the elderly group than in the young.Why? – When a vaccine is tested, the dose that gives the maximum effect is selected. For the elderly, it needs to be increased because their immune response is weaker. This means that the developers of “Sputnik V” were not mistaken with the dosage. In any case, a clinical study is a limited sample, so far we have only a rough idea of ​​the effectiveness of the vaccine. The final result will become clear later, when more people are vaccinated. If we get vaccinated every year, like against the flu, the effectiveness in different groups, including age groups, may change.Preliminary data on our and foreign vaccines show that there is no strong dependence on age. This is encouraging. This means that for the elderly there is no need to modify the drug, to increase the content of the antigen or viral vector. – Why is there an allergy to flu shots? – Influenza vaccines used in the world are being built up on chicken embryos. They may contain some residual protein that causes allergies. But this problem is no longer so urgent. Over the past 15 years, the level of purification of vaccine antigens has increased dramatically.The risk of significant contamination is minimal. “For what reason are inactivated influenza vaccines used in Russia?” Then they decided that the inactivated vaccine was safer and more effective, they practically abandoned the live one, which, in my opinion, was not entirely correct. In other countries, including the United States and England, both options are used. Live and inactivated influenza vaccines have different target groups.Alive is recommended for children to elicit a wider range of immune responses, including T-cell ones, which provide longer-term protection. The elderly are better off inactivated. But it is most likely impossible to transfer this directly to a coronavirus infection. – Inactivated vaccines against various infections are made in approximately the same way. Tell us more about it. “The virus is grown on cell culture or chicken embryos. For example, the SARS-CoV-2 strain for the CooviVac vaccine is accumulated in a Vero cell culture.The origin of the cell line is a purely technological issue. For the consumer, this does not matter, the degree of purification and the integrity of the preparation are important. Then, by some kind of influence (thermally, chemically or physically), they destroy the envelope of the virus, the genome, so that the particles become non-infectious. Each stage is checked. Further, they are purified from the components that remain during the destruction of the viral mass. The output is inactivated viral particles or fragments containing viral proteins. The former serve as the basis for whole-virion vaccines, the latter for split and subunit vaccines.This technology is more than a dozen years old. There are the fewest questions about the development of the Chumakov Center. In contrast to the Sputnik V and EpiVacCorona vaccines, the technological chains of which were created literally before our eyes. “Some are really waiting for the KoviVac, made using traditional technology. There is great interest in this drug. It turns out that it consists of torn viral particles? Does the antigen have to be whole? What’s with the RNA of the virus? ”“ It’s made from inactivated particles, it’s a whole virion vaccine. A natural antigen, a spike protein, remains in the vaccine, which triggers an immune response.Other structural proteins that make up the vaccine viral particle also perform this function. In this case, the RNA of the virus is inactivated. – When the vaccine is administered, its components do not penetrate into the cells of the body? – In the vector vaccine, the adenovirus enters the cells and the antigen is produced there. The inactivated already contains the antigen, it is injected into the muscle, it triggers a reaction of the immune system. “Doesn’t the infection occur?” Infection is the penetration of a live virus into cells and the reproduction of copies of it.In vector vaccines, the carrier virus enters the cell, causes the synthesis of the spike protein, but cannot replicate itself. So it is incorrect to talk about infection. “It turns out that the inactivated vaccine is aimed at a humoral response, it will not cause a T-cell one?” A balanced B- and T-cell response is induced by vector vaccines and RNA vaccines. They are still alive, attenuated, but there are none against the coronavirus. “Why is an adjuvant added to inactivated vaccines?” “Adjuvant are auxiliary molecules that stimulate the production of an immune response.It is needed to form a higher titer of protective antibodies. In influenza vaccines, an adjuvant is used if it is necessary to reduce the antigen content. “Why is one dose of vaccine enough for influenza, but two are required for coronavirus?” “For influenza, everything has been worked out for a long time, and much is done from covid from the wheels. Usually, in preclinical studies, it turns out that one dose is not enough and a second is needed to develop a protective antibody titer. Over time, other options are possible. Now, in a pandemic, you need to be sure that the drug will cause a good immune response.

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flu, gennady onishchenko, health, biology, covid-19 coronavirus, satellite v vaccine, epivaccorona vaccine, vaccination of Russians against covid-19, vaccine ” kovivak “

MOSCOW, April 22 – RIA Novosti, Tatyana Pichugina. According to Oxford statistics , at the moment in Russia about seven percent of the population have been vaccinated against coronavirus. By comparison, 53 percent of people, nearly 70 million people, including risk groups, were vaccinated against the flu last year. What is the difference between these vaccines, is it possible to combine them and how inactivated drugs are made, Doctor of Biological Sciences Andrei Vasin, Acting Director, Professor of the Institute of Biomedical Systems and Biotechnology of Peter the Great St. Petersburg Polytechnic University told RIA Novosti.

– Andrey Vladimirovich, in addition to the coronavirus, the elderly are being vaccinated en masse only against the flu. Is it effective?

– Yes. Although it is believed that the vaccination efficiency of the older generation is lower than that of the younger generation. If this is revealed during clinical or post-registration studies, the drug for the elderly can be modified, for example, by increasing the antigen content in the dose. In reality, the immune response is very individual and does not always depend on age.

– Has the massive flu vaccination made people sick less?

– Certainly.In Russia, the coverage of the population with influenza vaccination is probably the largest in the world. As a result, fewer hospitalizations for this infection, as well as the risk of severe complications and death, including among the elderly. This should be true for covid, which is most difficult for those over 60.

– Gennady Onishchenko said that 70 million people were vaccinated from the flu last year in Russia. That is, more than half of the population. Why, then, is vaccination against COVID-19 stalled?

– Let’s proceed from the fact that vaccinations against this infection are just emerging, everything is done on the fly.It is not easy to make 140 million doses of a new vaccine. Nevertheless, it is enough. Virologists, doctors see no signs that these drugs are working poorly or cause serious side effects. I don’t see that either. Perhaps people need to be more educated that the risk of serious complications, death from COVID-19 is incomparably greater than the likelihood of side effects from vaccinations.

March 22, 08:00 Science “It is dangerous not to be vaccinated.” The doctor spoke about vaccinations for the elderly

– Since everything is so well established with the flu, it would be logical to combine this vaccine with the coronavirus.

– It will not work – the preparations are based on different principles. Others need to be developed. This is being done at the Smorodintsev Research Institute of Influenza and the Institute of Experimental Medicine, both in St. Petersburg. They use the influenza virus as a carrier vector for the coronavirus antigen. But these vaccines will be ready at best next year.

– Then maybe introduce a lockdown? Self-isolate, maintain social distance, use protective equipment and wait for the end of the pandemic or the formation of herd immunity.

– Herd immunity consists of natural, obtained from infection, and artificial, stimulated by the vaccine. As far as I know, we are not yet close to the required indicators. Who is able to afford such a long self-isolation, even among unemployed pensioners? And how much more stay at home – six months, a year? Since the main risk group is the elderly, vaccination is the only correct way out for them. It is necessary to limit the spread of infection. The situation in Russia is better than in other countries.But it should be remembered that the pandemic is not over yet.

– According to phase III , the protective efficacy of Sputnik V is even higher in the elderly group than in the young. Why?

– When a vaccine is tested, the dose that gives the maximum effect is selected. For the elderly, it needs to be increased because their immune response is weaker. This means that the developers of Sputnik V were not mistaken with the dosage.

In any case, the clinical trial is a limited sample, so far we have only a rough idea of ​​the effectiveness of the vaccine.The final result will become clear later, when more people are vaccinated. If we get vaccinated every year, like against the flu, the effectiveness in different groups, including age groups, may change. Preliminary data on our and foreign vaccines show that there is no strong dependence on age. This is encouraging. This means that for the elderly it is not necessary to modify the drug, to increase the content of the antigen or viral vector.

April 16, 08.00

– Influenza vaccines used in the world are being expanded on chicken embryos.They may contain some residual protein that causes allergies. But this problem is no longer so urgent. Over the past 15 years, the level of purification of vaccine antigens has increased dramatically. The risk of significant contamination is minimal.

– For what reason are inactivated influenza vaccines mainly used in Russia?

– The first vaccine based on a live weakened influenza virus was created in the USSR in Leningrad under the leadership of Anatoly Aleksandrovich Smorodintsev. Then they decided that the inactivated vaccine was safer and more effective, they practically abandoned the live one, which, in my opinion, was not entirely correct.In other countries, including the United States and England, both options are used. Live and inactivated influenza vaccines have different target groups. Alive is recommended for children to elicit a wider range of immune responses, including T-cell ones, which provide longer-term protection. The elderly are better off inactivated. But it is most likely impossible to transfer this directly to a coronavirus infection.

– Inactivated vaccines against various infections are made in approximately the same way. Please tell us more about this.

– The virus is grown on cell culture or chicken embryos.For example, the SARS-CoV-2 strain for the CooviVac vaccine is accumulated in a Vero cell culture. The origin of the cell line is a purely technological issue. For the consumer, this does not matter, the degree of purification and the integrity of the preparation are important. Then, by some kind of influence (thermally, chemically or physically), they destroy the envelope of the virus, the genome, so that the particles become non-infectious. Each stage is checked. Further, they are purified from the components that remain during the destruction of the viral mass. The output is inactivated viral particles or fragments containing viral proteins.The former serve as the basis for whole-virion vaccines, the latter for split and subunit vaccines.

This technology is more than a dozen years old. There are the fewest questions about the development of the Chumakov Center. Unlike the Sputnik V and EpiVacCorona vaccines, the technological chains of which were created literally before our eyes.

– Some people are really looking forward to the “CooviVac” made with traditional technology. There is great interest in this drug. It turns out that it consists of torn viral particles? Does the antigen have to be whole? What’s with the RNA of the virus?

– It is from inactivated particles, this is a whole virion vaccine.A natural antigen, a spike protein, remains in the vaccine, which triggers an immune response. Other structural proteins that make up the vaccine viral particle also perform this function. In this case, the RNA of the virus is inactivated.

– When a vaccine is administered, its components do not penetrate the cells of the body?

– In a vector vaccine, the adenovirus enters the cells and the antigen is produced there. The inactivated already contains an antigen, it is injected into the muscle, it triggers a reaction of the immune system.

– Doesn’t the infection occur?

– No. Infection is the penetration of a live virus into cells and the reproduction of copies of it. In vector vaccines, the carrier virus enters the cell, causes the synthesis of the spike protein, but cannot replicate itself. So it is incorrect to talk about infection.

– It turns out that the inactivated vaccine is aimed at a humoral response, it will not cause a T-cell?

– Can give T-cell, but less pronounced.A balanced B- and T-cell response is induced by vector vaccines and RNA vaccines. Still alive, attenuated, but there are none against the coronavirus.

December 25, 2020, 08:00 The whole truth about the coronavirus vaccine

– Why is an adjuvant added to inactivated vaccines?

– Adjuvant are auxiliary molecules that stimulate the immune response. It is needed to form a higher titer of protective antibodies. In influenza vaccines, an adjuvant is used if it is necessary to reduce the antigen content.

– Why is one dose of the vaccine enough for the flu, and two for the coronavirus?

– For the flu, everything has been worked out for a long time, but from covid they do a lot from the wheels. Usually, in preclinical studies, it turns out that one dose is not enough and a second is needed to develop a protective antibody titer. Over time, other options are possible. Now, in a pandemic, you need to be sure that the drug will cause a good immune response.

April 9, 15:16 Infographics Vaccination against COVID-19 in Russia 90,000 Russians will not be able to get vaccinated with a foreign influenza vaccine until the end of autumn :: Society :: RBC

When will foreign vaccines be purchased

Currently, more than 20 influenza vaccines are registered in the state register of medicines, most of them are produced by the Natsimbio holding, which is part of the Rostec structure.Two of the foreign influenza vaccines are registered – “Vaxigripp” by the French Sanofi Pasteur and “Influvac” by the Dutch Abbott.

Read on RBK Pro

As explained in the analytical company DSM Group, since the influenza vaccine is produced by domestic companies in the framework of the “extra third” position, foreign companies cannot participate in tenders. In accordance with the rule, if at least two manufacturers from the EAEU countries enter the auction, the foreign manufacturer is not allowed to bid.

“At the same time, purchases for the national calendar of vaccinations, which include influenza, are carried out within the framework of the state order. That is, the manufacturer makes the vaccine in the required quantity for a specific order, ”the company adds.

The clinics surveyed by RBC now offer only domestic vaccines – “Grippol Plus” produced by “Petrovax” and “Sovigripp”. The Russian Ultrix Quadri is expected to arrive in mid-September. The last two vaccines are produced by Nacimbio.

As the representative of Medsi Alla Kanunnikova told RBC, the imported Vaxigripp will appear not earlier than October, and the use of Influvac in the network’s clinics is not planned at all. The network of clinics “Mother and Child” also offers to get a Russian flu vaccine, foreign vaccines are expected there in November, the clinic’s representative Dmitry Yakushkin found it difficult to specify which vaccines are in question.

Medical Director of the European Medical Center Evgeny Avetisov told RBC that, according to information from suppliers, Vaxigripp will appear no earlier than October, now one domestic vaccine is available in the clinic, Sovigripp, another, Ultrix, is expected later in September.

It will be possible to get a flu shot in the Bud Zdorov network of clinics that are part of the Ingosstrakh group of companies from mid-September. According to RBC, the general director of the network, Philip Mironovich, the clinics will offer domestic “Grippol Plus” and “Ultrix”. “The imported vaccine will be available in Russia, presumably, not earlier than the end of October – the first ten days of November,” Mironovich said to RBC, without explaining which foreign influenza vaccine would be available.

The director of the Rassvet clinic, Alexei Paramonov, told RBC that within a week the clinic expects the delivery of Ultrix Quadri, the French Vaxigripp is expected only in mid-October.

The medical center “CM-Clinic”, in response to a request from RBC, explained that vaccination against influenza is not being carried out this year. After the publication of the text, the representative of the clinic of JSC “Medicine” also told RBC that currently, vaccination against influenza can only be carried out with domestic vaccines. The clinic is expected to receive a foreign vaccine in October.

A flu shot must be done in September in order to minimize the risks of contracting coronavirus and influenza at the same time, says the President of the Union of Pediatricians of Russia Leyla Namazova-Baranova.According to her, there is no point in expecting a vaccine from a foreign manufacturer. “There are manufacturers of highly effective safe vaccines in Russia, for example, Ultrix Quadri. At the same time, COVID-19 has not gone anywhere, there are already publications describing patients who are sick with coronavirus simultaneously with the flu. The more people already get vaccinated against influenza, the fewer such severe cases of the simultaneous course of infections will be, ”the expert said.

As it was before

Lack of foreign vaccines during the epidemiological season is an annual problem.In 2018, according to Vedomosti, Vaxigripp produced by Sanofi Pasteur was delivered only by the end of September, while Influvac was not delivered at all. In 2019, according to Rossiyskaya Gazeta, at the beginning of October in Russia it was impossible to be vaccinated with a foreign vaccine.

Sanofi RBC reported that in 2020 they plan to continue supplying vaccines for the prevention of influenza.“The vaccine will be delivered to the country for further passage of the procedure for putting it into civilian circulation, and no earlier than in October, it will be available for shipment from the warehouse of Sanofi Russia JSC. The vaccine will be available through the traditional distribution network, ”explained Yuri Mochalin, director of corporate relations at Sanofi in the Eurasian region, to RBC.

Abbott did not respond to RBC’s inquiry about whether it is planned to supply Influvac vaccine to Russia.

Are there any claims to Russian vaccines

According to the director of the Rassvet clinic, Alexei Paramonov, domestic vaccines Grippol and Sovigripp contain a small amount of the main substance for the vaccine – the antigen.“Instead, they have immunomodulators that are poorly understood. These vaccines are available free of charge in clinics and vaccination points near the metro, but we do not use them. This year we will be inoculating with the domestic Ultrix Quadro, – he said.

Natsimbio rejected claims to the Sovigripp vaccine, noting that the drug has passed the full range of preclinical and clinical studies and has a safety and efficacy profile. In the latest post-registration studies, which took place during two epidemiological seasons from 2016 to 2018, 10 thousand people took part.people aged 18 to 35 years, randomly divided into two groups – the main and control. According to the results of the study, the Natsimbio explains, in the main group, the incidence of influenza was only 0.36%, in the control group it was 41 times higher.

Adding various adjuvants (immune response enhancers) to the vaccine is a common practice of pharmaceutical companies, says Vasily Vlasov, a lecturer at the Department of Health Care Management and Economics at the Higher School of Economics and a member of the Russian Academy of Sciences’ Commission for Combating Pseudoscience.“An adjuvant is a foreign substance that invigorates the body and enhances the response to the injected antigen. Antigen production is expensive and adjuvants cheap. To produce more doses, the amount of antigen is reduced and a foreign substance is added. There is no evidence that the adjuvants correspond to the injected antigen, ”Vlasov said.

The pharmaceutical company Petrovax told RBC that the inclusion of adjuvants in vaccines is “one of the main directions for improving vaccines recommended by WHO.”According to a company representative, the use of adjuvants allows for a pronounced immune response, increase the duration of the protective effect, and enhance the immune response in poorly responding patients – the elderly and people with weakened immunity. In response to the claim about the low antigen content in the Grippol Plus vaccine, Petrovax refers to the fact that in the pharmacopoeias of Europe, the USA and Russia, it is allowed to use less than 15 micrograms of antigen in the production of the vaccine, if clinical studies confirm its effectiveness.”Grippol” has such research, concluded in “Petrovax”.

Paramonov is confident that there is a shortage of foreign influenza vaccines on the Russian market, since the influenza vaccine itself is on the list of vital and essential medicines (VED). “The prices for them are regulated by the state; if the manufacturer agrees with the state on an acceptable price, then the drug is on the market. As soon as the cost is unacceptable, the drug disappears, this is a systemic problem of the drug market, ”he said.

Foreign influenza vaccines are poorly represented on the Russian market due to the fact that only domestic vaccines are involved in government procurement, he adds. “The imported ones get only the commercial market, but it is small, and this is unprofitable,” the expert concluded.

Reaction of the Ministry of Health

The press service of the Ministry of Health of RBC said that in total in the epidemic season 2020/21, more than 60 million doses were purchased for the vaccination of adults and children. “In Russia, the necessary vaccines already exist and will be able to protect citizens, they are produced in strict accordance with WHO recommendations and have fully proven their effectiveness and safety,” the ministry said.

90,000 Gunzburg announced the start of trials of a single vaccine against different viruses :: Society :: RBC

Center them.Gamalei has created a platform for a drug that will protect a person from different strains of the same virus or from different pathogens. Earlier, the center announced plans to create a single vaccine against influenza and coronavirus

Photo: Kirill Kukhmar / TASS

In the Center.Gamaleya has begun preclinical trials of a platform for a vaccine that will protect humans from different viruses circulating in society at the same time. This is reported by TASS with reference to the director of the center, Alexander Gintsburg.

“This is a vaccine that we have now begun to test in preclinical trials on monkeys. The meaning of this technology is that <...> you can immediately protect [a person] from different strains of the same pathogen, or even from different viruses circulating in the human population at the same time <...> ”, he said.

Gunzburg explained that for such a vaccine, for example, various antigens of influenza and coronavirus viruses are combined.

Gunzburg spoke about plans to create a single vaccine against influenza and coronavirus at the beginning of the year. Last week, he noted that the technology platform for the drug has already been created. “If everything goes well with this platform, this technology will work, then we will move on to a more complex option – combining influenza hemagglutinin antigens and, accordingly, coronavirus S-proteins in one vaccine,” he noted.

Clinical trials are scheduled to begin at the end of 2022.

The rise in incidence is said to be related to vaccines. This is true?

The virus mutates, but vaccines still help. First, mutations do not make the virus completely unrecognizable. They can change parts of the viral proteins, and this will reduce the ability of antibodies to attach to them. But the main thing is to what extent do viral particles manage to infect cells? It is this indicator that determines whether the body is protected from disease.

Recently, the international scientific journal Vaccines published an article on the effectiveness of the Sputnik V vaccine against four strains of coronavirus that are of concern to scientists. Each of these strains contains mutations in RBD, the receptor-binding domain of a coronavirus protein, which is responsible for connecting the virus to the cell. In theory, this could weaken the effect of vaccine antibodies, since they target this particular domain.

It turned out that the blood serum of people vaccinated with “Sputnik V” still suppresses the multiplication of two “Moscow” variants of the virus.And for more aggressive strains such as “beta”, “gamma” and “delta”, its ability to neutralize the virus drops by 3.1, 2.8 and 2.5 times, respectively. But this is still enough, since the initial vaccine rates were very high, the authors emphasize.

It should be borne in mind that vaccination protects not only from infection, but also from the severe course of the disease. You can look at the example of Great Britain, where more than 80% of people received the first dose of the vaccine, and both more than 50%. In mid-June, the number of infections began to rise in the country due to the spread of the more infectious Delta strain.On June 17, the number of daily cases reached February values. However, if then the number of deaths reached 500-1000 per day, then in June about ten people died a day.

In Russia, you can look at the example of one of the most famous covid hospitals – GKB # 40 (Kommunarka). According to the head physician Denis Protsenko, since the end of 2020, 23,281 infected people have passed through Kommunarka, of which 136 were vaccinated (less than 0.6%). Of these, 69 people received both doses. In this case, most often vaccinated people ended up in the clinic five to six days after the injection, that is, when the immunity might not have time to develop.

And this is another important point. Immunity does not begin to form immediately, but only after about a week (this can be seen in the graphs in the article on the results of clinical trials of “Sputnik V”). And it becomes fully formed only one and a half months after the first dose. Therefore, the vaccinated person should follow the precautions in the same way as everyone: wear a mask, disinfect his hands and avoid crowded places.

90,000 The doctor told why it is better not to get flu and coronavirus vaccinations at the same time

A flu vaccination program has already started in the Saratov region.The experts recalled that autumn is the best time for vaccinations, since it is best to protect yourself before the onset of the rise in the incidence. At the same time, vaccination against COVID-19 continues. When is the best time to be vaccinated, is there a threat of double infection and how to properly combine the two vaccinations? Yekaterina Volkova, a physician-therapist of “Invitro-Volga Region”, spoke about this.

Can those who have received the flu vaccine get vaccinated? Does vaccination protect against coronavirus and flu?

Coronavirus vaccination does not negate the importance of influenza vaccination, and vice versa.During the next wave of coronavirus infection and the emergence of new strains of it, any other infection can aggravate the course of the disease. If a mixture of coronavirus infection and flu happens, this can significantly increase the unfavorable course. Therefore, getting vaccinated against influenza is not only possible, but also necessary! In the 2020-2021 season, more Russians were vaccinated against influenza than in previous years. This growth can be explained by the influence of the coronavirus pandemic: people assessed the risks, including the development of co-infection, influenza and COVID-19.

When is the best time to get the flu shot? Do I need to wait time between flu and coronavirus shots?

All immunology experts agree that there is a need to take a break between vaccinations and that the flu vaccine should definitely not be injected between the first and second components of the COVID-19 vaccine.

Influenza and coronavirus vaccinations are best separated and not given at the same time. It is recommended that you complete your COVID-19 vaccination first and then get your flu shot.A month should pass between vaccinations. A break is necessary in order not to burden the body and to better track the side effects of vaccines, as well as to better determine the effect of vaccines. A person can write off the action, the manifestation of one vaccine for another, this can distort information. It is necessary to plan a personal vaccination schedule in such a way that a stable immunity has already been developed by the seasonal outbreak of influenza in November-December. For the formation of specific immunity after a flu shot, at least two weeks must pass.

This fall, clinical trials of a double-acting vaccine are underway that will simultaneously protect against coronavirus and influenza. The vaccine can be supplied as a spray. It is assumed that the drug will be single-phase and will require only one injection. The vaccine can be registered before the end of the current year or at the beginning of the next year.

Which flu vaccines are recommended?

Because influenza viruses are subject to continuous genetic and antigenic changes, WHO is updating its vaccine recommendations twice a year for the northern and southern hemispheres, respectively.The vaccine includes those viruses that are predicted to be most prevalent in the coming season. Since the composition of the vaccine is regularly updated, it is recommended to get the flu vaccine every year and before the start of the season for the best protection.

In Russia, 3-valent vaccines are available (Grippol, Grippol plus, Sovigripp, Ultrix, Flu-M) and 4-valent (Grippol quadrivalent, Ultrix quadri, Flu-M tetra), which will protect against 3 or 4 flu strains, respectively.It is better to make a tetravalent vaccine, but if it is not available, then you should not neglect the trivalent vaccine – it is much better than not being vaccinated at all.

Do I need a flu shot if I have recently had any ARVI or coronavirus?

Vaccination is necessary, but only under the direction and under the supervision of a doctor. The doctor must be sure that the patient’s condition is stable and that he does not have residual effects and complications after suffering a new coronavirus infection at the time of deciding on a flu shot.Antibodies after the disease do not persist as long as after vaccination. However, it is worth noting that if a person has been ill with COVID-19 or other acute respiratory viral infections, influenza vaccination is recommended no earlier than a month after recovery

Who is recommended to get vaccinated in the first place? And what are the contraindications?

For influenza, these are children, older people and people with chronic diseases of the lungs, cardiovascular, endocrine or nervous systems. Also, patients with oncopathology, immunodeficiency states, receiving immunosuppressive therapy if there are no contraindications to vaccination for the underlying disease.

In addition, people who, due to long-term work or other reasons, have an increased risk of contracting any acute respiratory infections. In fact, these are the same groups of people who are at risk of COVID-19, except for children.

Contraindications to vaccination against influenza and coronavirus are almost the same: the presence of acute, including respiratory, diseases or exacerbation of chronic diseases, age up to 6 months for influenza vaccination, research is also underway on vaccination against covid in adolescents, allergies, intolerance to vaccine components and severe complications from previous vaccinations.

What strains of influenza will come to Ukraine this year

Will there be a flu epidemic this year? When is the best time to get a flu shot, which vaccine to choose and how much does it cost? What strains of influenza are expected in the country this year and why we receive so few vaccines against the virus, Focus figured out.

Infectionists assure that the ideal time for influenza vaccination is September and early October , that is, before the active circulation of viruses begins.This allows the body to build up immunity and develop enough antibodies, which will take about two weeks. The problem is that there is practically no vaccine in Ukrainian pharmacies now, but it is already possible to get such a vaccine in private clinics. And the bulk of the drugs are delivered at the end of October, and most often in November.

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This does not mean that there is no point in getting vaccinated later.As noted in the Ministry of Health, it is possible to vaccinate even when outbreaks of disease have already been recorded in the region. Contrary to popular myth, this procedure does not weaken, but, on the contrary, enhances the body’s ability to withstand the flu, the department says.

In a recent interview, Igor Kuzin, the country’s chief sanitary doctor and deputy minister of health, said that this epidemic season, Ukrainian pharmacies should receive about million doses of vaccines against influenza .Last year the number was even smaller – about 650 thousand

Why a million doses of influenza vaccine is “about nothing”

“One million for the whole country is about nothing,” comments Andrei Alexandrin, epidemiologist and head of the National Expert Group on Infection Control. However, it is important to understand, the expert reminds, that the influenza vaccine is not mandatory in Ukraine and is not included in the vaccination schedule approved by the Ministry of Health, that is, a person must independently take care of being vaccinated.People can either buy the drug at the pharmacy and go to the hospital where they get the vaccine, or go to one of the private clinics where they buy the vaccines themselves, so the patient doesn’t have to worry about the logistics. True, in the latter case, the cost of the procedure increases several times. Judging by the last year, flu vaccination costs 250-300 UAH if you buy the drug at a pharmacy, and up to 1.5 thousand UAH if you go to a private clinic.

Vaccination reduces the risk of severe illness and complications by 60% and reduces the likelihood of death by 80%

In the 2020/2021 season, several drugs could be found in Ukraine, including the French “Vaxigripp” and the South Korean “JC Fly”.As infectious disease specialist Evgenia Menzhulina notes in a conversation with Focus , despite the fact that vaccines are sold in Ukrainian pharmacies without a prescription, you should not buy them without first consulting a doctor. Only a specialist can determine which drug is exactly right.

The supply of vaccines to the country is driven by demand.

“Distributors initially form an order in accordance with the applications. When the epidemic season begins, a predetermined number of doses are brought to Ukraine,” says Alexandrin.

Many private clinics pre-book influenza vaccines, resulting in a limited supply of drugs to pharmacies. In the fall of 2020, pharmacists said that vaccines were sold out within an hour after the start of sales. According to family medicine doctor Darina Dmitrievskaya, this is a normal process. If you buy a drug in a pharmacy on your own, then you need to take care of the observance of special conditions during its transportation, because the vaccine should be transported in a special container, but not everyone follows the instructions.

“The clinic ensures the observance of the temperature regime,” the expert comments. The introduction of a spoiled vaccine does not pose any danger, but it will no longer work.

Rehearsal for COVID-19

“Last year I turned to Mikhail Radutsky [head of the parliamentary committee on the health of the nation] and Maxim Stepanov [ex-minister of health] and said that the vaccine campaign against influenza 2020 / 2021 is a dress rehearsal for vaccination against COVID-19, “says Andrei Alexandrin.According to him, if the Ministry of Health could organize mass vaccination of the population against influenza, it would show that Ukraine is ready to vaccinate people against coronavirus. However, the campaign failed: in the last epidemic season, only about 200 thousand people were vaccinated against influenza, that is, 0.5% of the country’s population. At the same time, 11.2% of Ukrainians have had the flu. As Igor Kuzin notes, many of the disease was difficult, with subsequent complications.

Darina Dmitrievskaya believes that the reluctance of Ukrainians to get vaccinated is associated with myths widespread among the population.Often people do not understand that they need to be vaccinated annually.

“Yes, you need to get vaccinated every year,” the doctor confirms. One of the reasons people refuse vaccines is their cost. However, influenza treatment can cost several thousand hryvnias, so it pays off.

Important

The man who defeated the black death.How Odessa citizen created vaccines against plague and cholera

The main mistake of the Ministry of Health is the almost complete absence of vaccination propaganda. In Ukraine, there is a lack of social advertising that explains why vaccines are needed and what effect they have. Meanwhile, vaccination reduces the risk of severe disease and complications by 60% and reduces the likelihood of death by 80%.

“Until our country has its own production of influenza vaccine, no one will be interested in investing in educational programs and informing people,” Andrei Alexandrin is sure.

However, the chief medical officer recently announced plans to manufacture drugs in the country.

“Ukrainian pharmaceutical manufacturers are negotiating to localize the production of influenza vaccines in Ukraine,” the official said. It is assumed that the domestic vaccination will appear in the first half of 2022.

Another problem of Ukraine Alexandrin calls the too complicated procedure for obtaining the drug. According to him, the whole process can be simplified if it is possible to vaccinate people not only in hospitals.

“This is an elementary vaccination, there is nothing complicated, it could be done directly in pharmacies or even in public places,” the expert is sure. The availability of vaccinations would immediately have a positive effect on the number of people vaccinated.

Influenza epidemic: promising prognosis

According to the World Health Organization, the following virus strains will circulate in Ukraine during the 2021–2022 season: type A / Victoria (h2N1), type A / Cambodia (h4N2), type B / Washington (B / Victoria), B / Phuket (B / Yamagata) .That is, the situation is almost identical to last year’s. According to Igor Kuzin, new strains are not expected to appear in the country in this epidemic season.

Important

Anthrax, COVID and plague. Terrible epidemics that began with the leak from the

laboratory

Andrey Alexandrin also gives optimistic forecasts, who is sure that flu epidemics will not happen .This is the merit of those restrictive measures that exist and will be introduced additionally. As the experience of last year shows, quarantine really helped to reduce the spread of not only coronavirus, but also other respiratory diseases. At the same time, the epidemiologist is concerned that many states, including Ukraine, have not drawn conclusions from the pandemic and are not ready to invest in infrastructure development. In particular, ensure adequate ventilation in closed spaces.

90,000 FAKE: There was no Spanish flu pandemic, people were dying from mass vaccinations

Checking fakes in partnership with Facebook

Facebook users spread information that the alleged Spanish flu pandemic was faked, and people died from vaccinations. In addition, the alleged Spanish flu is not transmitted by airborne droplets, and in fact it is bacterial pneumonia. Even Dr. Fauci allegedly wrote about this.

However, it is not so .

The Spanish flu epidemic is not fictional. And it actually killed at least 50 million people.

These deaths were not caused by vaccinations. There was no vaccine during the Spanish flu pandemic, so people could not die from it. The first influenza vaccine was made in the United States only in 1940.

Such fakes have already been denied by foreign independent fact checkers from Facta and Maltida.

It is groundless to assert that a Spanish flu pandemic or COVID-19 is planned.

The Spanish flu was not bacterial pneumonia. And Dr. Fauci did not write about it.

The Spanish flu was caused by virus , and bacterial pneumonia is caused by bacteria .

Fauci’s study states that during the Spanish flu pandemic, the virus destroyed cells in the bronchi and lungs, making it easier for bacteria to enter the lungs and causing bacterial pneumonia.

Most of the people who died during the Spanish flu pandemic were extremely weakened by the influenza virus, and therefore suffered from bacterial pneumonia.

This fake was also denied by independent foreign fact checkers from Reuters and AFP.

Research has really failed to infect people with the Spanish flu virus on purpose.

However, the author of the study, Rosenau, concludes that possibly volunteers had immunity .The author also notes that the study shows how little we know about the Spanish woman.

The authors of another experiment also failed to artificially transmit the virus from patients to healthy ones. Among the possible reasons, they speak of unknown additional factors , which were not taken into account when isolating the virus from a patient or infecting healthy ones.

Due to the limited amount of research, it is not known how the Spanish flu infection occurred. Perhaps animals also played a key role.The CDC notes that the Spanish flu virus is “a unique and deadly product of nature, evolution and the mixing of humans and animals.”

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