mRNA flu vaccines are under study (2023)

mRNA flu vaccines are under study (1)

Following the successful use of mRNA vaccines to prevent COVID-19, three major drug manufacturers have introduced seasonal influenza vaccine candidates made using the technology in early clinical trials. Other companies intend to follow suit next year (Table 1).

If successful, these candidates could dramatically increase the effectiveness of a vaccine class that often offers lackluster protection. For mRNA advocates - led by Moderna, Pfizer and Sanofi, which began Phase I trials in recent months - new flu vaccines could be profitable or help maintain their position in a faltering global market, estimated at more of $10 billion by end of the decade.

Table 1 | Select mRNA vaccines for seasonal influenza in and is approaching the clinic


Product's name



influenza antigen(s)

No Hospital






Translate Sanofi/Bio

MRT-5400, MRT-5401


Monovalente (H3N2)





Monovalent (H1N1) and monovalent (B/Yamagata), to be combined into bivalent and quadrivalent




mRNA-1020, mRNA-1030



Hemaglutinina + Neuraminidase




Quadrivalent + COVID-19


the inns


Tetravalent and pentavalent (two strains of H3N2)








Monovalent (H1N1)





cepa of hemagglutinina







undisclosed amount



a tie




a tie

undisclosed amount

Not disclosed

oneMRT-5400 and MRT-5401 are based on unmodified RNA. NIAID, National Institute of Allergy and Infectious Diseases; saRNA, autoamplifying RNA.

But flu shots can also be a tougher test for mRNA than COVID-19. Because, unlike SARS-CoV-2 – for which there were no established medical interventions – nine flu vaccines from four different vaccine manufacturers are now available in the US alone.

These vaccines are safe, but their effectiveness leaves room for improvement. Existing flu vaccines, whether built around inactivated viruses or recombinant proteins, typically offer only 40 to 60 percent protection against infections. In theory, mRNA could be a better product: the induced immune responses could be broader, the expressed proteins should have better sequence fidelity, strain selection could be more precise, and the technology facilitates the incorporation of large numbers of antigens. All these properties can lead to better immune protection.

But mRNA, at least when formulated into lipid nanoparticles (LNPs), is prone to compatibility issues. Moderna and Pfizer/BioNTech approved mRNA syringes for COVID-19 commonly cause arm aches, headaches, low-grade fever, and fatigue. The same symptoms can occur with approved flu shots, but they are usually much milder.

mRNA "is a tool that has some positive potential," says Gary Nabel, former CSO of Sanofi, founding director of the NIH's Vaccine Research Center (VRC) and CEO of immunotherapeutic company ModeX Therapeutics. "The big hurdle is security."

(Video) The Importance of mRNA Flu Vaccines With Dr. Bell

To impact the established market, the platform would need to find a more forgiving sweet spot and deliver big power benefits.

And yet, it is not certain that the mRNA will be able to efficiently transport the hemagglutinin glycoproteins, the main antigen of flu vaccines. “Have we really had incredible luck with COVID vaccines because of the antigenic design and immunodominance of this protein?” asks Anna Blakney, an RNA bioengineer at the University of British Columbia. "Or have we stumbled upon something that also works for other viral glycoproteins?"

I'll do it

Many of the leading mRNA-based influenza candidates were working on influenza vaccine candidates prior to the pandemic. Then came the new coronavirus, and "we literally swapped the flu coding sequences and the SARS-CoV-2 sequences," says Philip Dormitzer, Pfizer's head of viral vaccine research.

The whole field benefited from it. Seqirus was left out of the COVID-19 vaccine race despite having a self-amplifying mRNA platform that provides both the antigen coding sequence and the necessary replication machinery for the construct to replicate in the host cell. (Seqirus acquired this platform from Novartis in 2015.) "Seeing an mRNA vaccine work and getting such a robust response has alleviated some of the outside concerns people might have had about the technology overall," says Ethan Settembre, vice president of research and development on Seqirus.

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

Part of that comes down to how vaccines are made. Because mRNA vaccines are produced synthetically by encoding a target antigen sequence on a plasmid template, they offer high fidelity: the encoded antigens exactly match the influenza strains selected for each year's vaccine. In contrast, inactivated virus vaccines made in egg- and cell-based systems often undergo sequence mutations that weaken their effectiveness.

Vaccines using recombinant proteins offer the same fidelity benefit, but the manufacturing process for them is comparatively complicated. The flexibility and speed of manufacturing mRNA vaccines means that vaccine manufacturers can wait longer before starting to manufacture - for example, for the Northern Hemisphere, they can start production in May instead of February. This would allow them to make more informed decisions about which tribes to include.

"All the time helps," says Sally Mossman, director of GlaxoSmithKline's vaccine research and development center in the United States.

enter the multiplex

There may be other efficacy benefits. The US has quadrivalent vaccines containing hemagglutinin antigens (purified from inactivated viruses or produced recombinantly) or live attenuated viruses that provide protection against four strains of influenza. (Other jurisdictions still use trivalent vaccines.) Some researchers have argued for additional protection against additional strains, but this is logistically difficult with existing platforms.

(Video) mRNA Flu Vaccines: Preventing the Next Pandemic

Not necessarily with mRNA.

A team led by Norbert Pardi of the University of Pennsylvania Perelman School of Medicine and Raffael Nachbagauer, then at the Icahn School of Medicine at Mount Sinai, demonstrated this last year. They immunized mice against an influenza subtype with amRNA vaccine encoding four different proteins: Hemagglutinin rod, neuraminidase, matrix 2 ion channel and nucleoprotein. Along with Meagan McMahon of Mount Sinai, Pardi and her colleagues repeated the exercise for two other flu subtypes. They plan to test a combination vaccine with 10-12 antigens in mice and ferrets. Ideally, this achieves such broad immune protection that it does not need to be taken every year.

Many researchers also expect mRNA to stimulate stronger or more diverse immune responses than traditional platforms. If this is truemay be particularly beneficial for older adultsthat often respond poorly to flu shots, notes Jenna Bartley, who studies immune aging at the University of Connecticut School of Medicine.

It could even help develop a universal flu vaccine that protects against all strains of the virus, says Tony Moody of Duke University. With support from the NIH, he is now developing an mRNA-based hemagglutinin-stabilized parental vaccine that is modeled on a protein-based vaccine already available in the clinic. "It's an informative experiment," says VRC director John Mascola. "We don't know how to induce high levels of persistent antibodies, and the mRNA may differ in how it triggers that response."

Current vaccine technologies often elicit only humorous responses that block viral invasion. mRNA vaccines may elicit better T-cell responses because they mimic natural infections.

Barney Graham also sees a broader societal opportunity: by working with seasonal mRNA candidates today, companies should be better prepared to fight influenza pandemics in the future. "This is where mRNA can really change the business," says Graham, who retired as associate director of the VRC at the end of August. "If we really had a pandemic, you could design [a new vaccine] within 10 minutes of getting the sequence, and you could get your hands on the mRNA within a few weeks."

show me the dates

The only human data reported to date on an mRNA-based flu vaccine comes from Moderna's initial foray into the clinic. As of late 2015, the company was evaluating two two-dose vaccines, each designed to target a different strain of avian flu.

According to former Moderna CMO Tal Zaks, the main purpose of these attempts was to test the company's mRNA. "If you want to show that the technology works, the easiest place to start is with a flu shot," he says. In the flu, he explains, the correlates of protection – measurements of immunological parameters that allow predicting the effectiveness of the vaccine – are well defined. There are also established vaccines to which clinical outcomes can be linked.

For many viewers, Moderna's first attempts were a disappointment. Although most study participants who received higher doses of the experimental vaccines developed influenza-specific antibody titers above the threshold considered protective - as measured using the well-validated haemagglutination inhibition assay (HAI) - theseantibody levels have decreasedjust a few months after vaccination. This suggests that the protection they offer may be short-lived. T cell immunity was not detectable.

(Video) COVID: Pfizer and BioNTech study efficacy of combo COVID-flu vaccine

Former heads of companies who were involved in the lawsuits see things differently. Both Giuseppe Ciaramella, former head of infectious disease research, and Michael Watson, former president of Moderna's vaccines division, argue that the vaccines induced a robust set of memory B cells that remember antigens and the rapid production of antibodies can trigger when people are sick - exposed to the virus.

They highlight data from 5 participants who received their two injections 6 months apart, rather than 3 weeks apart like everyone else. These subjects achieved much higher mean HAI titers - "proof", says Watson, "that the first dose prepared very well".

However, Watson is less optimistic about the tolerability results. Although Moderna has since changed its LNP formulation and aspects of its mRNA design, its data from early studies suggested that the therapeutic index for an mRNA-based influenza vaccine could be low. This can be problematic for multicomponent seasonal flu vaccines that aim to train the immune system to recognize at least four antigens.

Moderna is still making clinical progress - and has already started adding additional antigens to its next generation of flu products. Neuraminidase, another surface glycoprotein, will be included in the company's follow-up clinical candidates. Other antigens that may better stimulate T-cell immunity are also being considered. The company is also preparing combination vaccine candidates that can protect against several respiratory viruses. One, for COVID-19 and flu, is scheduled to enter clinical trials next year.

But adding antigenic targets will likely require higher total vaccine doses, Watson points out, potentially triggering more serious side effects. "It's definitely the yin and yang," he says.

open session

Nachbagauer, who joined Moderna last year to lead its infectious disease research and development efforts, is aware of the safety concerns but is taking a wait-and-see approach to the issue. The company's first seasonal influenza vaccine candidate, mRNA-1010, consists of four mRNA sequences encoding hemagglutinin glycoproteins from viral lineages recommended by global health authorities and formulated into the same LNPs used to deliver the COVID-19 vaccine. 19 of the company. "We're really interested in how our reactogenicity is," he says.

The immune connections between pandemic and seasonal flu vaccines are completely different, adds Nachbagauer. Pandemic flu vaccines are supposed to protect against a new threat. As people generally do not have pre-existing immunity to them, a two-dose vaccination schedule is critical. With seasonal flu, most people have been exposed to the related strains or have received previous flu shots. Just one shot can therefore be enough to protect against the latest adaptation of an ever-changing opponent. If the COVID-19 vaccines are any guide, a one-dose candidate may be more tolerable than a two-dose product.

Moderna began a mRNA-1010 dose-ranging study with 180 people in July. It is expected to run until early 2022.

Sanofi and Pfizer have also placed their first mRNA-based flu vaccines in Phase I testing. These companies are taking measured approaches to de-risking mRNA platforms, starting with candidates that contain only a single mRNA that encodes the hemagglutination head domain of an influenza virus type.

(Video) mRNA Flu Shot Moves Forward As Pfizer Launches Late-Stage Trial, Builds On Covid Vaccine Success

Sanofi is evaluating its monovalent H3N2 vaccine candidate in two different LNP formulations. "If the results are positive, clinical development of a quadrivalent influenza vaccine would be the next step," said Frank DeRosa, chief technology officer at Sanofi subsidiary Translate Bio. (Sanofi acquired Translate for $3.2 billion earlier this year.)

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 based on this unmodified mRNA platform successfully elicited antibody responses in early clinical trials. But it has not yet been proven in an efficacy study. CureVac's unmodified mRNA COVID-19 vaccinestumbled upon phase III trials, raising the possibility that this strategy may be inferior to modified mRNA candidates.

This may explain why Sanofi also plans to have a modified mRNA-based quadrivalent vaccine in clinics next year. CureVac is considering both mRNA options for its flu vaccine in partnership with GlaxoSmithKline.

Meanwhile, Pfizer is developing two parallel programs: one with modified mRNA and the other with an auto-amplifying construct. Their modified mRNA candidate, PF-07252220, is first. (Pfizer licensed the technology from BioNTech and chose to go it alone in the influenza program.) In September, the company began a Phase I trial of this monovalent vaccine at four dosage levels, each injection containing a single influenza A or B contained stress. It is planned to combine them later into a bivalent vaccine, given in different doses, before moving to a quadrivalent product - all compared to an approved flu vaccine.

Pfizer also plans to begin testing its self-amplifying mRNA candidate in the coming months.

A well trodden path

For each mRNA-based vaccine that advances to the later testing phase, the regulatory path to approval is well defined: companies must either demonstrate efficacy through classic clinical trials or demonstrate non-inferiority to an approved comparator in a surrogate measure of protection. as the title of HAI. "That's the beauty of the flu," said Pad Chivukula, chief scientific officer and chief operating officer of Arcturus Therapeutics. "The path to approval is very easy."

The correlation approach is less expensive and involves less risk, especially for vaccines optimized to induce antibody production. But it won't capture the protection that comes from inducing responses from T cells or other arms of the immune system, a potential downfall for mRNA candidates. The correlated approach also does not support claims of platform superiority when it comes to breadth or longevity of protection. Most companies that have mRNA-based vaccines in the works, therefore, assume that they will eventually conduct large-scale studies over one or more flu seasons.

"Ultimately," says Dormitzer, "to really convince people to switch to a new vaccine platform, they're going to want to see efficacy alongside all the immunological comparisons."

While there has been a sharp drop in flu cases around the world over the past year, likely due to mask wearing and social distancing in response to COVID-19, most experts expect the flu to return. When that happens, the companies hope that their mRNA-based vaccine candidates will be ready.

(Video) New flu shot using mRNA platform could soon be available


How good is the flu vaccine match this year? ›

Centers for Disease Control and Prevention (CDC) data indicate that the 2022-2023 influenza season flu vaccine formulations are a good match to protect against the currently circulating flu viruses.

What kind of vaccine is the flu shot? ›

All flu vaccines for the 2022-2023 season are quadrivalent vaccines, designed to protect against four different flu viruses, including two influenza A viruses and two influenza B viruses. Different vaccines are licensed for use in different age groups, and some vaccines are not recommended for some groups of people.

How effective was last years flu vaccine? ›

A new CDC analysis of 2021-22 data reveals that flu vaccine effectiveness (VE) against the H3N2 (influenza A) strain for all ages was 36%.

What is Flublok quadrivalent? ›

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)]. 2.

When is the 2022 2023 flu season? ›

When is flu season? Flu season began on October 15, 2022 and is slated to end at the end of May 2023. During the 2021-2022 flu season, the CDC and New York State Department of Health extended their influenza surveillance through the end of June due to a late increase in flu cases.

What strains are in 2022 flu shot? ›

Cell- or recombinant-based Vaccines
  • an A/Wisconsin/588/2019 (H1N1)pdm09-like virus;
  • an A/Cambodia/e0826360/2020 (H3N2)-like virus;
  • a B/Washington/02/2019 (B/Victoria lineage)-like virus; and.
  • a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

How many deaths has the flu vaccine prevented? ›

Flu vaccines prevent about 7.5 million illnesses, 3.7 million doctor visits, 105,000 hospital stays and 6,300 deaths.

How effective is the flu vaccine really? ›

While vaccine effectiveness (VE) can vary, recent studies show that flu vaccination reduces the risk of flu illness by between 40% and 60% among the overall population during seasons when most circulating flu viruses are well-matched to those used to make flu vaccines.

How long has the current flu vaccine been around? ›

Vaccines are an effective means to control outbreaks of many diseases. However, vaccines for respiratory viral infections such as flu are still suboptimal and do not offer broad-spectrum protection. Vaccination against influenza began in the 1930s, with large-scale availability in the United States beginning in 1945.

Which is better Fluzone or Flublok? ›

The amount of antigen in Fluzone High-Dose Quadrivalent is four times higher than the amount of antigen in standard flu vaccines, such as Fluzone Quadrivalent and Flublok. This high amount is meant to provide a stronger immune system response in older people, who may have a higher risk of the flu and its complications.

Who should not get Flublok? ›

Who should not get Flublok Quadrivalent? People who are not within the FDA-approved age range (those younger than 18 years) and who have had severe allergic reactions to any ingredient of the vaccine should not get Flublok Quadrivalent.

Which is better Flublok or flucelvax? ›

Flublok outperforms Fluzone and Flucelvax in eliciting influenza HA-specific antibody responses.

Does the flu last longer than COVID? ›

Both the flu and COVID-19 cause a cough and shortness of breath, but overall, COVID-19 symptoms tend to last longer than the flu. “They can last for multiple weeks, if not months,” says Dr. Wong.

What is the difference between the regular flu shot and the senior flu shot? ›

Some high-dose flu vaccines include 3 to 4 times as much flu virus antigen — the part of the vaccine that stimulates the immune system — as standard flu vaccines.

Which month has the most flu cases? ›

During this 40-year period, flu activity most often peaked in February (17 seasons), followed by December (7 seasons), January (6 seasons) and March (6 seasons). When is flu season in the United States?

What is the flu vaccine ingredients? ›

Ingredients often include deactivated influenza viruses, chemicals that boost the body's response to the vaccine, preservatives to prevent contamination, and stabilizers. The CDC recommend getting a flu shot in September or October, but getting one any time during flu season will help.

How many virus strains are in the flu vaccine? ›

A quadrivalent influenza (flu) vaccine is designed to protect against four different flu viruses, including two influenza A viruses and two influenza B viruses. Learn more about the vaccine composition for the current flu season vaccines.

How many variants of flu are there? ›

There are four types of influenza viruses: A, B, C, and D. Influenza A and B viruses cause seasonal epidemics of disease in people (known as flu season) almost every winter in the United States. Influenza A viruses are the only influenza viruses known to cause flu pandemics (i.e., global epidemics of flu disease).

Why do health workers decline flu vaccination? ›

Myths and beliefs about the flu vaccine among HCWs and the community are the main reason of resistance in the flu campaign. Increasing knowledge on flu vaccine side effects could reduce the belief that the flu vaccine can give you flu.

Is there an overdose of flu vaccine? ›

An overdose of this vaccine is unlikely to occur.

Does the flu shot weaken your immune system? ›

A: No. The flu shot does not weaken your immune system or make you more likely to get the flu. Getting your annual flu shot prepares your immune system to fight off the flu.

What are the pros and cons of the flu shot? ›

Vaccination is important for people at risk of severe illness from the flu. Flu shots can have some mild side effects, such as pain and bruising at the injection site. However, getting the flu vaccine every year is the best option to prevent flu from spreading and causing severe illness.

How many people died from flu when it started? ›

It is estimated that about 500 million people or one-third of the world's population became infected with this virus. The number of deaths was estimated to be at least 50 million worldwide with about 675,000 occurring in the United States.

How long did the COVID vaccine take to make? ›

Many people were astonished at how quickly the COVID-19 vaccines were developed. Although the first vaccines were created, evaluated and authorized for emergency use in under a year, rest assured that no steps were skipped in ensuring their safety and effectiveness.

What is the most recent way flu vaccines are made? ›

Currently, cell culture-based manufacturing is used to make inactivated flu vaccines (e.g., flu shots), not LAIV (nasal spray flu vaccine).

Does Flublok contain formaldehyde? ›

No formaldehyde. No thimerosal or other preservatives. No latex.

Why is the nasal flu vaccine not recommended? ›

Nasal spray flu vaccine is not recommended for use in people with some chronic health conditions because the safety and effectiveness of this vaccine in people with those conditions has not been established.

Is there mercury in Flublok? ›

Answer: Flublok is the only licensed flu vaccine that does not use eggs, antibiotics or influ- enza virus in any part of the manufacturing process. Flublok does not contain thimerosal (mercury derivative), gelatin or latex. Flublok has 3 times more antigen than traditional flu vaccines*.

Which vaccine Cannot be given to immunocompromised? ›

Persons with most forms of altered immunocompetence should not receive live vaccines (MMR, varicella, MMRV, LAIV, yellow fever, Ty21a oral typhoid, BCG, smallpox, and rotavirus).

Which vaccine is best for an individual who is allergic to eggs? ›

For the 2021-2022 flu season, there are two vaccines licensed for use that are manufactured without the use of eggs and are considered egg-free: Flublok Quadrivalent (licensed for use in adults 18 years and older) Flucelvax Quadrivalent (licensed for use in people 6 months and older)

Which vaccine not use if Pat has allergy from egg? ›

Yellow Fever Vaccine and Egg Allergies

However, all yellow fever vaccines are cultured in eggs, and healthcare providers advise those with a history of severe allergic reactions to avoid the vaccine.

Who produces Flublok? ›

Sanofi Pasteur produces the following vaccines: Fluzone. Vaxigrip/Vaxigrip Tetra. Flublok.

Who made Flublok? ›

Sanofi Pasteur recently acquired Protein Sciences that developed Flublok Quadrivalent vaccine, using a recombinant DNA technology.

Which COVID vaccine has eggs? ›

The COVID-19 vaccines authorized by FDA are not manufactured using egg products or technology. So there's nothing to talk about there even if you're allergic to egg.

Do previous year flu shots protect you? ›

– Influenza vaccines given in prior years may provide protection against the flu for more than one year, according to a study published online today in the journal Clinical Infectious Diseases.

How effective was the flu shot in 2015? ›

The overall VE against A(H1N1)pdm09 was 41% and the overall VE against influenza B was 55%. This data is consistent with VE observed during previous seasons when vaccine viruses and circulating viruses were similar. These vaccine effectiveness estimates were derived from data collected from the U.S.

How effective was the flu shot in 2014? ›

For influenza A and B combined, the overall adjusted VE was 19% (CI, 10% to 27%) against all medically attended influenza and was statistically significant in all age groups except those aged 18–49 years.

How effective was the flu shot in 2010? ›

Our results indicate that the 2010 seasonal trivalent influenza vaccine is >80% effective against pandemic (H1N1) 2009 virus, regardless whether given by itself or in addition to monovalent vaccine.

Why do we need a flu shot every year but not other vaccines? ›

Why is it important to get a flu vaccine EVERY year? Flu viruses are constantly changing, so flu vaccines may be updated from one season to the next to protect against the viruses that research suggests will be common during the upcoming flu season. Your protection from a flu vaccine declines over time.

Why do we have to have a repeat of the flu vaccination every year? ›

The vaccine takes around 10 days to work and should help protect you during this year's flu season. You have to get immunised every year because flu viruses change constantly and your immunity reduces over time. The flu vaccine can't give you flu, but it can stop you catching it.

How many died from flu in 2016? ›

The overall burden of influenza for the 2016-2017 season was an estimated 29 million influenza illnesses, 14 million influenza-associated medical visits, 500,000 influenza-related hospitalizations, and 38,000 influenza-associated deaths (Table: Estimated Influenza Disease Burden, by Season — United States, 2010-11 ...

How many died from flu in 2015? ›

The overall burden of influenza for the 2015-2016 season was an estimated 24 million influenza illnesses, 11 million influenza-associated medical visits, 280,000 influenza-related hospitalizations, and 23,000 flu-associated deaths (Table: Estimated Influenza Disease Burden, by Season — United States, 2010-11 through ...

Is the H1N1 vaccine a live virus? ›

The 2009 swine flu pandemic vaccines were influenza vaccines developed to protect against the pandemic H1N1/09 virus. These vaccines either contained inactivated (killed) influenza virus, or weakened live virus that could not cause influenza.

What are the side effects of the flu vaccine 2022? ›

More information about the 2022-2023 flu season is also available.
Common side effects from the flu shot include:
  • Soreness, redness, and/or swelling from the shot.
  • Headache.
  • Fever.
  • Nausea.
  • Muscle aches.

What year was the flu vaccine shortage? ›

In early October 2004, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced it would not release any vaccine for the 2004–05 season because of potential contamination.


1. Influenza mRNA Vaccines: Mechanisms and Methodologies
(TriLink BioTechnologies)
2. COVID-19 mRNA Vaccine: Will It Change My DNA?
(Nucleus Medical Media)
3. What You Need To Know About Flu Vaccines Heading Into The Fall
4. COVID: Pfizer and BioNTech study efficacy of combo COVID-flu vaccine
(Yahoo Finance)
5. Why we need a better flu shot
6. Moderna stock drops after posting interim data for mRNA flu vaccine
(Yahoo Finance)
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