Category: Flu Vaccine

A health care worker prepares an injection of Pfizer's Covid-19 vaccine Comirnaty, Sept. 14, 2023.

Irfan Khan | Los Angeles Times | Getty Images

A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Vaccine makers have set their eyes on the next big thing: Developing combination shots targeting both Covid and the flu.

As Covid vaccination rates in the U.S. dwindle, Pfizer, Moderna and Novavax, among other companies, hope that more convenient combo shots offering protection against two viruses rather than one will increase uptake among Americans. Some health experts have cast doubt on that belief, CNBC previously reported.

Still, combo jabs may also reduce the burden that respiratory viruses which typically spread at the same time each year put on pharmacists and the broader U.S. health-care system.

The race to develop those jabs is heating up, as all three companies test their respective vaccines in mid- or late-stage trials.

But Pfizer and its German partner BioNTech faced a setback last week that may allow rival Moderna to pull ahead.

Pfizer on Friday said its messenger RNA-based vaccine that combines its approved Covid shot with an experimental flu shot failed to meet one of the main goals of a phase three trial on more than 8,000 adults, potentially jeopardizing the jab's future.

The vaccine produced a more effective immune response against influenza A strain than a licensed flu vaccine and was as effective against Covid as Pfizer's existing product. But the shot showed a weaker immune response against another flu strain called influenza B compared with the licensed flu vaccine.

Pfizer and BioNTech will consider adjustments to the combo shot and "discuss next steps with health authorities," according to a release.

"We remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps," Annaliesa Anderson, Pfizer's head of vaccine research and development, said in the release.

Mikael Dolsten, Pfizer's outgoing chief scientific officer, said at a conference in March that the company hopes to launch its combination shot in 2025. It's unclear whether Friday's results change that timeline.

If it does, that could be good news for Moderna. The biotech company's mRNA-based combination shot succeeded in a late-stage trial in June, showing higher immune responses than existing standalone shots for Covid and the flu.

Moderna plans to file for regulatory approval for that shot and hopes it can enter the market in 2025.

"Failure of this [Pfizer and BioNTech] combo vaccine study puts [Moderna] in the lead in the mRNA combo vaccine development," Leerink Partners analyst David Risinger said in a note Friday, adding that Pfizer's "update incrementally improves the odds that [Moderna's shot] could be the first commercially available combo mRNA vaccine."

Pfizer's stumble could also be good news for Novavax and Sanofi, which partnered earlier this year to develop protein-based combination Covid and flu shots. In May, Sanofi, a top flu shot maker, agreed to pay Novavax up to $1.2 billion up front and future milestones in part to work on combining the companies' vaccines.

Still, there is a chance that Pfizer could make the right tweaks to its vaccine to get it back on track toward regulatory approval. For example, Moderna's initial standalone flu vaccine similarly failed to show an immune response as effective as an approved vaccine against influenza B before the company made adjustments to overcome that setback.

We'll be watching closely for any updates in the combination shot space, so stay tuned.

Feel free to send any tips, suggestions, story ideas and data to Annika atannikakim.constantino@nbcuni.com.

The eponymous sign outside Epic headquarters in Verona, Wisconsin.

Source: Yiem via Wikipedia CC

This is Ashley, reporting live from Verona, Wisconsin!

I'm here attending Epic Systems' annual Users Group Meeting, or UGM, for the first time, and it's sure to be an eventful day.

Epic is a health-care software giant whose technology is used in thousands of hospitals and clinics across the country. Its 1,670-acre headquarters is nestled about 30 minutes away from Madison, and thousands of health-care leaders are gathered here to talk tech this week.

The main event will be Tuesday's executive address, where Epic's CEO Judy Faulkner and other senior leaders will share updates about the company's latest initiatives. It takes place in a partially underground auditorium called "Deep Space," which can seat more than 11,000 people.

Deep Space is a central fixture of Epic's notoriously quirky campus, which is adorned with statues of wizards and buildings themed like "The Wizard of Oz" and "Alice in Wonderland." Don't worry, I'm going on a guided tour this afternoon, so I'll have much more to share about this soon.

But if that isn't enough to pique your interest, Epic executives will also deliver the address in costume. The theme of this year's UGM is "Storytime," according to the company's website. Remember this next time anyone tries to tell you health care is boring.

As far as announcements go, I expect we'll hear a lot about Epic's work to integrate artificial intelligence into its software. The company already has more than 60 AI development projects underway, according to its website, and its high-profile partnerships with AI scribing companies such as Abridge and Microsoft's Nuance Communications have generated a lot of industry chatter this year.

Perhaps unsurprisingly, both Nuance and Abridge are here attending UGM.

Epic has also made waves in the health-tech interoperability space this summer. The company is one of the organizations that's been helping the federal government establish the Trusted Exchange Framework and Common Agreement, or TEFCA, to provide a legal and technical framework for securely sharing patient data.

Epic said Friday that it's planning to move all of its customers to TEFCA by the end of next year. It's a big move: Because of Epic's dramatic reach and its 45-year history on the market, the company's commitment to TEFCA will likely bolster the exchange's credibility.

I would bet Epic's leadership will touch on these efforts, as well as other ways the company is working to leverage its vast network.

Stay tuned for lots more UGM content from me this week! And if you have tips about where I can track down the best cheese curds on campus, please get in touch.

Feel free to send any tips, suggestions, story ideas and data to Ashley atashley.capoot@nbcuni.com.

Here is the original post:

Healthy Returns: The race to develop combination shots targeting Covid, flu is heating up - CNBC

If you're looking to get your flu and COVID vaccine, there are some upcoming clinics you should know about.

Portland announced there will be several public clinics starting in early October that will run until mid-November.

The clinics are open to people both with and without insurance.

If you have insurance, you should bring proof.

The CDC recommends anyone aged 5 or older get a COVID vaccine and anyone six months or older get a flu shot.

Friday, October 4, 9:00 AM-12:00 PM

Friday, October 4, 2:00-5:00 PM

Sunday, October 6th, 2:45-4:45 PM

Thursday, October 10th, 1:30-4:30 PM

Tuesday, October 15th, 9-11:00 AM

Sunday, October 20th, 2:00-4:00 PM

Tuesday, November 12th, 1:30-3:30 PM

September 3, 3:30-6:30 PM

Tuesday, September 17, 1-3:30 PM

Tuesday, September 17, 1-3:30 PM

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Public vaccine clinics to start in Portland in October - WGME

THURSDAY, Aug. 22, 2024 (HealthDay News) -- A universal flu vaccine that would protect against all influenza strains -- and that people might not need to take every year -- could be close at hand, researchers report.

An experimental vaccine candidate produced a strong immune response in lab mice, and it provided protection against severe infection after the critters were exposed to the virus, researchers reported Aug. 22 in the Journal of Virology.

The candidate flu vaccine combines eight proteins from five different types of influenza virus, in hopes of providing immune protection against any type of flu that might strike the United States, researchers said. However, more investigation needs to be done, since animal-based trials don't always pan out in humans.

Using data from previous studies, researchers concluded that these eight proteins together could provide a sustained and universal immune response against the flu, said lead researcher Naoko Uno, a virologist and postdoctoral fellow with the Cleveland Clinic.

Weve been able to whittle down this list, to say these are the best at spanning multiple seasons and eliciting a broadly reactive antibody response, Uno said of the eight proteins. Its like creating a greatest hits album. We want to put only the best ones back in the vaccine.

Researchers believe the vaccine also might be able to last longer than a single season, potentially ending the annual ritual of flu jabs.

We want to make sure our vaccine can span multiple seasons, not just one, and protect against all the strains that affect humans, Uno said in a journal news release.

Seasonal flu vaccines include proteins from three or four flu strains, which are chosen by looking at which strains are circulating on the other side of the world during their influenza season.

But its a guessing game, because the flu virus mutates so quickly. An unanticipated flu strain could burst into the United States without warning, or a chosen protein might produce an inadequate immune response because the virus has changed subtly but significantly.

To craft a potential universal flu vaccine, researchers downloaded thousands of genetic sequences of flu strains spanning multiple seasons.

They then analyzed those sequences to identify which proteins were common across all flu strains.

The resulting vaccine includes proteins from H1, H2, H3, H5 and H7 types of influenza virus, researchers said.

H1 and H3 commonly circulate among humans, while the other types occur in animalsbut have pandemic potential if they leap into humans, researchers said.

For example, the H5N1 bird flu has been spreading rapidly through poultry and livestock in the United States, raising concerns that the flu could jump into people.

Researchers hope to launch human clinical trials for the universal vaccine within one to three years, Uno said.

More information

The U.S. Centers for Disease Control and Prevention has more on the seasonal flu vaccine.

SOURCE: American Society of Microbiology, news release, Aug. 22, 2024

Continued here:

Universal Flu Vaccine Blocks Infection in Mice - HealthDay

A new universal flu vaccine candidate has shown promising results in animal models, providing protection against various influenza strains and paving the way for upcoming human trials.

Cleveland Clinic researchers have developed a universal flu vaccine candidate showing strong immune responses in animals, with human trials expected soon. This vaccine could potentially protect against various influenza strains over multiple seasons.

Annual flu vaccines protect against severe infection, but they vary in efficacy and may not match the most virulent strains of the season. The reality of a universal flu vaccine, which would protect people from all strains, and ideally longer than a single season, remains elusive.

Findings published this week in the Journal of Virology suggest were getting closer. Researchers at Cleveland Clinics Lerner Research Institute have reported that their universal flu vaccine candidate, tested on animal models, elicited a strong immune response and provided protection against severe infection after viral exposure. The new work builds on previous, similarly promising preclinical studies on mice from the same group, led by Ted M. Ross, Ph.D., Director of Global Vaccine Development at Cleveland Clinic.

The researchers hope to launch human clinical trials within 1-3 years, said virologist Naoko Uno, Ph.D., who led the new study. We want to make sure our vaccine can span multiple seasons, not just one, and protect against all the strains that affect humans, she said.

Scientists have identified 4 types of influenza virus, but 2 of themInfluenza A and Influenza Bpose the greatest risks to humans. Seasonal flu vaccines include proteins from 3 or 4 circulating subtypes of those viruses, which include H1N1, H3N2 and IBV. But because the virus mutates so quickly, predicting which strains will pose the biggest risk, and thus choosing which ingredients to include, is a guessing game.

Researchers in Ross lab designed their new vaccine candidate using a methodology called COBRA, or Computationally Optimized Broadly Reactive Antigens. They began by downloading thousands of genetic sequences of pathogenic influenza strains, spanning multiple seasons, from an online database. Then they digitally analyzed those sequences to identify which amino acidsthe building blocks of proteinsare conserved across viruses and seasons.

The researchers identified groups of proteins for different subtypes. To develop a wider-reaching vaccine, Uno said, the group identified 8 proteins from those previous studies associated with a sustained immune response. Weve been able to whittle down this list, to say these are the best at spanning multiple seasons and eliciting a broadly reactive antibody response, she said. Its like creating a greatest hits album. We want to put only the best ones back in the vaccine.

Those greatest hits included proteins from H1 and H3 types of influenza viruses, Uno said, but they also included proteins from H2, H5, and H7 viruses, which are strains against which most people dont have antibodies. Some of these have pandemic potential, Uno said. Past outbreaks of bird flu, or H5N1, have led to a high rate of human mortality, and in March 2024 the virus was found in dairy cattle in Texas. Since then, 4 people who work with cattle have been diagnosed. In addition, it has spread to dozens of herds in multiple states, and in other species including sea lions, birds, cats and alpacas.

Weve shown that our H5 vaccine does cover many different clades, Uno said.

For the new work, the Cleveland Clinic researchers administered the vaccine candidate intranasally. Blood tests showed that 4 weeks later the animals had developed antibodies against the virus, and when the animals were exposed to the pathogen they were protected against developing infection.

Ross currently leads his groups efforts to advance testing of the candidate in the U.S., and Uno is collaborating with researchers in India and the European Union on an international effort.

Uno noted that the COBRA methodology isnt limited to finding and assembling recombinant proteins for the flu. It might be used to analyze mRNA or other biomolecules, she said, or explored for developing vaccines to viral diseases like dengue. This can be used in a lot of viruses, she said.

Reference: 22 August 2024, Journal of Virology. DOI: 10.1128/jvi.00354-24

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Cleveland Clinics Groundbreaking Universal Vaccine Could End Flu Season Woes - SciTechDaily

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Salina's health providers offering vaccine clinics as flu season approaches - Salina Journal

Flu season typically starts later in the fall, however, to avoid symptoms like fever, coughing and body aches, it's important to vaccinate early.

EAU CLAIRE (WQOW) -Summer is still in swing, but with fall around the corner also comes flu season.

Flu season typically starts later in the fall, however, to avoid symptoms like fever, coughing and body aches, it's important to vaccinate early.

Allison Gosbin, a public health nurse with the Eau Claire City-County Health Department, advises anytime between September and October is the best time to get the seasonal vaccine. However, it's important to note that it still takes roughly two weeks for the shot to be fully effective.

"In recent years we have seen flu activity already starting in the end of October and peaking in December, so we don't know if that will be the case this year, but if you have your flu shot before the end of October, you're prepared then," Gosbin said.

The vaccine for this year also comes with a change. In previous years the shot has included four strains of the flu virus, now it contains just three. This is because the fourth strain hasn't been detected globally since 2020.

Some places, like Walgreens, are offering the flu vaccine now.

Have a story idea? Let us knowhere

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What to know ahead of flu season - WQOW TV News 18

Jeremy Faust is editor-in-chief of MedPage Today, an emergency medicine physician at Brigham and Women's Hospital in Boston, and a public health researcher. He is author of the Substack column Inside Medicine. Follow

Emily Hutto is an Associate Video Producer & Editor for MedPage Today. She is based in Manhattan.

In part 2 of this Instagram Live discussion, MedPage Today editor-in-chief Jeremy Faust, MD, Katelyn Jetelina, PhD, MPH, and Katrine Wallace, PhD, talk about the science and anxiety surrounding a potential H5N1, or avian flu, pandemic.

Jetelina is the author of "Your Local Epidemiologist" newsletter. Wallace is with the School of Public Health at the University of Illinois at Chicago.

Watch part 1 of this interview here, where they discuss the recent rise in measles cases in the U.S.

The following is a transcript of their remarks:

Faust: I do want to move on to threat number two, H5N1 -- bird flu, avian influenza.

Just to let everyone know if they haven't gone to virology camp, seasonal flu is one thing. Year to year, there can be changes in the genetic code -- that's called antigenic drift -- but then if you have a complete swap out of a big, huge chunk of the genetic material, that's called shift.

And that usually happens and that does happen when you combine maybe one part of a flu from a bird with maybe a human flu virus, and they intermingle and out comes a new version of this virus, which we don't have any sort of immune memory to. And so H5N1 could be one of these highly pathogenic avian influenzas. That's the setup.

Again, I'll start with Dr. Wallace. What do we know about this virus, this H5N1?

Wallace: Obviously people have probably heard that we've had some human cases, all of which have been people that work directly with either poultry or dairy cattle. So there hasn't been any person-to-person spread of this virus. It doesn't seem like it's very good at spreading between people. It hasn't achieved the kind of mutations it would need to do that, so that's good.

But what I find to be a little surprising is that we're not doing a whole lot of surveillance on cattle unless they're being moved across state lines, which is the law, but we're not really doing a whole lot of active surveillance here. There's been some testing of people, but I think only like 60 people have been tested for it or something like that.

So it makes me a little bit nervous that we don't have a handle, really, on the numbers that we would need to have.

Everybody's worried that it might become like the next pandemic, and you keep seeing headlines like that. I don't think that this virus, on its own, will probably become that.

I could be wrong obviously, but what worries me is, like you're saying, one of these shift situations where a person who's working in one of these farms who has influenza already gets a co-infection with this H5N1 and then has some kind of recombinant virus that can then lead to it being more transmissible in humans.

That's what worries me about it. That's why I feel like we need to be doing a little bit more surveillance to make sure that doesn't happen.

Faust: You said that very clearly, but just to repeat something and add to it -- the way that these major pandemic-potential bugs emerge in flu is just as you said, a co-infection, so that something that's spreading through humans but is causing a normal amount of influenza disease -- which is not a good thing, but nor is it a 1918 situation -- but it's spreading in the way we would see in December and January. Imagine combining that degree of spread with the ability to cause disease that is on a 1918 level or a COVID level, and now you've got a problem.

What's interesting is, as you said, we're not seeing a human-to-human spread, but shots on goal, right? I mean, if this happens during flu season, a co-infection with a highly contagious but otherwise run of the mill flu, it could be a real shit show. I don't usually swear on these things, but I just feel like that's what we're dealing with here.

Dr. Jetelina, you are plugged into a lot of organizations and healthcare leaders that are watching this. What's the mood on the inside?

Jetelina: What's the mood on the inside? I think it depends who you ask. I think there are really two big camps here. One, that they don't believe that this is going to turn into a pandemic. And the other, that is "Let's prepare for the worst and hope for the best."

I think I'm more in the camp of "Let's prepare for the worst and hope for the best." The probability of this turning into a massive pandemic is small, like about 2% to 5% --

Faust: But that sounds big to me! That sounds huge!

Jetelina: But if we catch it, we have some huge implications to that, right? Especially since we think H5N1 is more deadly than COVID-19 or even seasonal flu that we see.

I think there's also a lot of frustration. Just like Dr. Wallace said, we feel like we can be doing more, we should be doing more. The really huge challenge with H5N1 is you have other groups, because this is a one health problem, it has animals and has humans and has a virus. So you have to get all these people talking on the same level.

The challenge is that they have different priorities. They have different legal authority, they have conflicts of interest -- it's election year, and a lot of these outbreaks are happening in swing states. I mean, it's really hard to watch, especially coming off the heels of a COVID pandemic.

So I don't know, I guess we'll see what happens. I am concerned about fall, I'm concerned about these mixing vessels that you guys are talking about. We know that pigs are mixing vessels, but we haven't seen H5 in pigs yet. We don't know if cows are mixing vessels, they certainly could be, because they have both receptors to bird and human. And then there's of course just humans working very closely to cows that could have influenza at the same time they go to work and you get a mixing vessel.

So I don't know how to answer that question other than, there's a lot of mixed feelings right now.

Faust: We had a question just now in the chat from Dr. Marcio Nehab about how long does it take to produce a big amount of vaccines for bird flu? And I think that's a great question to tackle.

First of all, I want to preface this by saying that one of the things that went well in the COVID experience was Operation Warp Speed. That was our effort to get a vaccine out, and there were a couple of things that made that work.

One was to sort of combine phase one and phase two and to get phase three going really quickly.

Another thing that helped -- which was not even a matter of the policy of Operation Warp Speed, but just the situation -- was that a lot of times vaccine trials take a long time because you don't have enough cases. Unfortunately, in the COVID experience, we had plenty of cases, right? So we got data. We usually would've expected it would take 10 years to get as many cases for a pathogen that we're interested in preventing. It took a few months.

But the third thing that was so important that gets to this question is that the companies got permission to start making the vaccine before we knew it worked. Meaning [the companies] were going to be made whole, the government was going to pay Moderna, in our case, and then Pfizer. Even if it didn't work, they were going to get paid for that stuff. That way if it did work, we didn't have to build up and spend months and months producing this stuff.

Do we have any idea of how long it would take to get 10,000 doses of a new vaccine, and then a million, and then a hundred million?

Wallace: What I do know is that Moderna has entered into the same type of deal with the NIH to develop a bird flu vaccine here in the U.S. So that's at least being worked on, it's already underway. And I guess they're trying to do it pretty quickly because flu season is coming up.

Faust: I'd forgotten about that. $176 million, right? It's funny how many news cycles ago that was. I forgot! I know. But I actually don't know, and maybe you don't either, whether that money is purely "Just go make the stuff and test it," or is part of that "If it works, make us a couple million doses, then if that works, do that a hundred times."

Wallace: I don't know.

Faust: Yeah. But I think that Warp Speed showed that principle at work, which is that we could get it done in 100 or 150 days.

Jetelina: Yeah. I'll add to that we already are manufacturing vaccines. We'll have 5 million ready in August. Those aren't mRNA vaccines, they're your traditional types of vaccines, but that's a really big difference from COVID is that we're not starting from zero. We actually know a whole lot about H5N1. In fact, we know exactly where it needs to mutate so we start seeing human-to-human transmission. So I think that we're already ahead.

The other thing that we have in place is we already have a massive system in place to manufacture and distribute flu vaccines. So we just need to figure out what's that "oh shit" line where we start integrating it into our full flu vaccine pipeline. That gives me a little hope.

The challenge is that like we just saw with COVID-19, vaccines aren't everything. It's not going to fix it. We actually don't know how well a H5N1 vaccine would work once it mutates to humans. We don't know how much prior immunity to flu will help. We have a lot of unanswered questions.

And so, I urge people not to just say, "Hey, we will have a vaccine. We'll be fine." Because it can turn into quite a disaster quickly.

Faust: There's a good question someone here has. Dr. Jetelina, when you say a 2% to 5% chance of becoming a pandemic, what's the timeframe of that over the next year or the next 20 years?

Jetelina: Every year. So every year we have about a 2% chance of any pandemic hitting. Now, with H5 and it's spreading in cows and we're close to cows and humans are getting infected, that increases the probability a little. So that's why I say 5% to 7%. I haven't done the math, but that's just my back of the napkin guess.

Faust: Right. It's funny you mentioned like the two moods, when people are more hopeful or more measured. But it seems to me like the cautionary principle is often invoked in a weird way that means alarmism. I think this is a good example of the precautionary principle being important.

Like you and me, we don't have to act like there's bird flu in our neighborhood right now, but there are farmers and surveillance workers who do. And so I think the action items aren't for the average person right now. The action items are for public health officials and people working in the cattle and bird space.

Jetelina: Right. And I actually think that's a really important distinction that leaders aren't really making that much clearer. Because there's a time when epidemiologists and virologists freak out, right? That's kind of now. We're like, "This is not great. Red flag, red flag," but that doesn't translate to "red flag, red flag" to the general public because there's no action for them to do. And the problem coming off the heels of COVID is that red flag for epidemiologists was directly translated to red flag for the general public.

But this is a very different situation right now, and I think we could do better communicating that disconnect so people don't feel fear or anxiousness or hopelessness. Because literally, their risk is low and there's nothing that they can do unless they're working on farms.

Faust: Right. And I think that the risk is low thing, that's very much a today thing. That's like the weather forecast. The risk of rain today is low here, but the risk of rain next month is high.

Read more from the original source:

Opinion | How Worried Should We Be About a Bird Flu Pandemic? - Medpage Today

(Precision Vaccinations News)

A recent study found that the Fluad MF59-adjuvanted influenzavaccine (aTIV) was more effective than the high-dose flu vaccine (HD-TIV) at preventing severe respiratory complications in older adults with risk factors.

Published inOpen Forum Infectious Diseases on August 16, 2024, the study included 1,115,725 aTIV and 2,561,718 HD-TIV recipients. For the primary outcome, the analysis found comparable effectiveness between aTIV and HD-TIV (rVE [95% CI]: 5.2% [-5.915.1]) among those with 0 risk factors, whereas aTIV was more effective than HD-TIV among patients with 1, 12, or 3 risk factors (12.5% (10.015.0), 18.4% (13.722.9), and 10.4% (7.413.3), respectively).

The same trends were observed for the secondary outcomes.

Previous studies have found the two vaccines to be similar in effectiveness in older adults.

The Fluad vaccinehas an extensiveclinical legacy and has been licensed in 30 countries since its first approvalin 1997. Fluad is available at most pharmacies in the U.S. for the 2024-2025 flu season.

Go here to read the rest:

Adjuvanted Flu Shot Protects Seniors Better - Precision Vaccinations

Pfizer and BioNTech have announced that a Phase III trial studying their investigational combination mRNA vaccine for the treatment of influenza and Covid-19 has failed to meet one of its two primary endpoints.

While the vaccine demonstrated a trend of higher responses in neutralising the influenza A strain compared to a licensed influenza vaccine, it failed to demonstrate non-inferiority against the influenza B strain in geometric mean titers (GMT) and seroconversion, as per a 16 August press release. Additionally, data indicated that the combination vaccine showed comparable responses for SARS-CoV-2 when compared to Pfizers licensed approved Covid-19 vaccine, Comirnaty (tozinameran).

The randomised, parallel assignment Phase III study (NCT06178991) enrolled over 8,000 adults aged 18 to 64 years old to evaluate the safety, tolerability, and immunogenicity of a single dose of the combined vaccine for protection against influenza and Covid-19. No new safety signals were found in the Phase III study.

Todays results provide insight and direction towards achieving this goal, and we remain optimistic about our combination Covid-19 and influenza program, for which we are evaluating the next steps, said Annaliesa Anderson, PhD, Senior Vice President and Head, Vaccine Research and Development at Pfizer.

Comirnaty, which gained full approval from the US Food and Drug Administration (FDA) in August 2021, is indicated for use in individuals aged 12 years and older for protection against Covid-19. The vaccine achieved peak sales of $42.4bn in 2022. However, there has been a decline in Covid-19 revenues in recent times, with pharma scrambling to make up the deficits.

In May, Pfizer announced a cost reduction programme to combat declining Covid-19 revenues, which was expected to save the company approximately $1.5bn by 2027. This measure came after the company announced in October 2023 that it would implement a $3.5bn cost-saving programme to combat a $5.5bn non-cash charge after the US government returned nearly eight million courses of the companys Covid-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir).

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However, mRNA Covid-19 vaccines could continue to be in the news as the FDAs Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to update the existing Covid-19 vaccines, including Comirnaty, to target the JN.1 variant. Aside from Pfizers Comirnaty, the FDA has granted traditional approval to Modernas SpikeVax (elasomeran).

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Pfizer and BioNTechs Covid-19/flu combination vaccine falters in Phase III readout - Clinical Trials Arena

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