Latest news with #mRNA-1083
Medscape
7 days ago
- Health
- Medscape
Could One Shot Replace Flu and COVID-19 Vaccines?
A novel multicomponent messenger RNA (mRNA) vaccine, mRNA-1083, demonstrated noninferiority to standard influenza and COVID-19 vaccines in adults aged 50 years or older, eliciting higher immune responses against most influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Yamagata) and SARS-CoV-2 ( Omicron XBB.1.5), according to a pivotal phase 3 study. METHODOLOGY: The mRNA-1083 is an investigational, multicomponent vaccine that combines the components of a hemagglutinin-based influenza vaccine (mRNA-1010) and a second-generation SARS-CoV-2 vaccine encoding the spike glycoprotein's N-terminal and receptor-binding domains. Researchers present interim findings of a phase 3 trial that assessed the immunogenicity and safety of this vaccine in adults aged 50 years or older across the United States, enrolling participants between October 19, 2023, and November 21, 2023. They randomly assigned 8061 participants to receive either the mRNA-1083 vaccine plus placebo or the active comparator vaccines for seasonal influenza or COVID-19. Participants were stratified into those older than 65 years (n = 4017; 54.2% women) and those aged 50-64 years (n = 3998; 58.8% women). The primary objective was to demonstrate the noninferiority of humoral immune responses — measured by antibody levels — to mRNA-1083 vs active influenza and COVID-19 vaccines against vaccine-matched strains, 29 days post-vaccination. TAKEAWAY: The mRNA-1083 vaccine demonstrated noninferiority to the active comparator vaccines against the four influenza strains and SARS-CoV-2 in both age groups, as determined by a 97.5% CI lower bound greater than 0.667 for the geometric mean ratio and more than −10% for the seroconversion rate difference. In adults aged 50-64 years, mRNA-1083 elicited superior immune responses to all four influenza strains relative to the active comparator influenza vaccines, whereas in adults aged 65 years or older, superiority was observed for three strains (A/H1N1, A/H3N2, and B/Victoria). Most local and systemic adverse reactions were grade 1 or 2 across vaccine groups. Grade 4 adverse reactions, all of which were systemic events (fever), were reported by two participants in each age group. In both age groups, no severe or serious adverse events or adverse events of special interest were deemed vaccination-related. No deaths or cases of myocarditis or pericarditis were reported. IN PRACTICE: 'As such, an annual vaccination campaign with a multicomponent vaccine could occur during the seasonal period when the burden of respiratory hospitalizations is the greatest, while allowing for a standalone COVID-19 vaccine option for additional doses or if the vaccine is updated in the interim should any antigenically divergent strain emerge,' the authors wrote. SOURCE: This study was led by Amanda K. Rudman Spergel, MD, Moderna Inc., Cambridge, Massachusetts. It was published online on May 7, 2025, in JAMA . LIMITATIONS: The efficacy of mRNA-1083 was not established in the study and requires further investigation. Although the diversity of the study population mirrored that of the general US population, the results may not be generalizable to other geographic areas. DISCLOSURES: This study was funded by Moderna, Inc. Many authors were employees of Moderna and may hold stock or stock options.
Yahoo
21-05-2025
- Business
- Yahoo
Moderna Provides Update on BLA Submission for Combination Vaccine Against Influenza and COVID-19
CAMBRIDGE, MA / / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the withdrawal of the BLA for mRNA-1083, plans for future resubmission of the mRNa-1083 BLA, and anticipated timing for efficacy data for Moderna's seasonal flu vaccine candidate, mRNA-1010. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media:Chris RidleyGlobal Head of Media Relations+1 Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire
Yahoo
20-05-2025
- Health
- Yahoo
2-in-1 COVID-flu vaccine looks promising, but approval could be delayed
When you buy through links on our articles, Future and its syndication partners may earn a commission. Two might be better than one: A new vaccine that targets the viruses behind seasonal flu and COVID-19 triggers a stronger immune response than flu and COVID shots given separately, trial data suggest. The combination shot, dubbed mRNA-1083, is made by the pharmaceutical company Moderna. The promising results of the Phase 3 clinical trial of the vaccine were published May 7 in the journal JAMA. This late-stage trial included two groups of adults ages 50 and older who were given either the new vaccine or a combination of previously approved flu and COVID-19 vaccines. The trial runners looked at the quantity of antibodies, or protective immune proteins, made in response to each vaccine regimen. Antibody levels correlate with how well a shot should protect against a disease and how long that protection might last. They do not provide direct data on how well a shot drives down infection rates in real life — but ethically, such real-world data is difficult to gather when effective vaccines against an illness already exist. While the U.S. Food and Drug Administration (FDA) has not yet given mRNA-1083 a final stamp of approval, experts told Live Science that the trial results are largely positive. However, political factors could hinder the shot's approval, some say. The U.S. Centers for Disease Control and Prevention (CDC) already recommends that people get both their annual flu and updated COVID-19 vaccines at the same time. But at the moment, that requires two separate shots to be given at the same appointment. The combination vaccine would be "a one-stop shop," said Dr. Peter Chin-Hong, an infectious-disease doctor at the University of California, San Francisco (UCSF) who was not involved in the Moderna trial. "A lot of times, people are not excited about needles. I mean, who likes getting a shot?" he told Live Science. With the decline in vaccination rates in the United States, a combination vaccine offers more convenience and helps people get on top of their immunization, he said. The idea of combining multiple immunizations into one shot is not new. "It is a very commonly used strategy, especially in children," said Dr. Monica Gandhi, an infectious-disease doctor at UCSF who was not involved in the study. An example of this is the measles, mumps and rubella (MMR) vaccine, which is a combination of three vaccines in one shot. The new mRNA-1083 vaccine is based on the same messenger RNA (mRNA) technology that Moderna used in its FDA-approved vaccine against SARS-CoV-2, the virus behind COVID-19. mRNA is a genetic molecule that relays instructions for cells to build different proteins. The new COVID-flu shot combines the company's updated SARS-CoV-2 vaccine, called mRNA-1283, and its newly developed flu vaccine, mRNA-1010. As of yet, there is no FDA-approved flu shot that contains mRNA, so this could be the first. The culprits behind seasonal flu are influenza A and B viruses, which can be further classified into subtypes and lineages. Current flu vaccines in the U.S. guard against two subtypes of influenza A viruses, called H1N1 and H3N2, and one influenza B virus lineage, known as the Victoria lineage. (Until very recently, the shots also guarded against a second lineage, called "Yamagata," but it's likely extinct.) The flu component of the new vaccine contains genetic instructions for human cells to make glycoproteins — molecules of protein and carbohydrate — found in these four flavors of influenza A and B viruses. These glycoproteins, known as hemagglutinins (HA), are located on the surface of flu viruses and enable the viruses to latch onto host cells and initiate infection. Once made, these proteins are shown to the immune system so it can recognize the viruses and fight them off. Likewise, the COVID component of the new vaccine contains the genetic instructions to make the proteins displayed by SARS-CoV-2, called spike proteins. "mRNA vaccine is the vaccine of the future, particularly when you want to respond to rapidly changing diseases or new variants," Chin-Hong said. Whereas the molecules in mRNA vaccines can be manufactured very quickly as a virus evolves, conventional flu vaccines take months to make. Chin-Hong described mRNA vaccine production as "cutting and pasting a code"; the mRNA that encodes the virus protein can be conveniently incorporated into the platform. Moderna has already completed Phase 3 clinical trials for the individual flu and COVID components of its new combo vaccine. On its own, the flu shot triggered higher immune responses than two conventional flu vaccines — Fluarix and the high-dose Fluzone — against A(H1N1) and A(H3N2) strains. It triggered comparable immune responses against influenza B viruses, based on the trial results. Moderna also showed that its new COVID vaccine induced greater immune responses than Spikevax — the FDA-approved shot — against XBB.1.5, a version of the omicron variant that's been circulating recently. Both vaccines were tested on adults ages 18 and older. The purpose of Moderna's latest Phase 3 clinical trial was to measure the robustness of the immune response the mRNA-1083 vaccine triggers in people. The trial runners measured this by looking at the number of antibodies vaccinated people produced against both the flu and the SARS-CoV-2 viruses. Real-world data, which would indicate whether the vaccine effectively lowers rates of hospitalization or emergency visits from the infections, is not yet available. Consistent with these earlier studies on individual vaccines, the mRNA-1083 combination shot triggered a strong immune response against all four influenza viruses and XBB.1.5. In the trial, the company recruited two groups of participants: one consisting of adults ages 50 to 64, and another including people 65 and older. Each cohort consisted of about 4,000 adults. The 50-to-64-year-olds received either the new combo shot or a combination of Fluarix and Spikevax. The 65-and-older cohort received either mRNA-1083 or a combination of high-dose Fluzone and Spikevax. (Fluzone, a high-dose flu shot, is approved for adults ages 65 and older and some younger people with weakened immune systems.) The researchers sampled the trial participants' blood at Day 1 and Day 29 of the experiment to measure the levels of antibodies. They found that the mRNA-1083 vaccine triggered a more robust immune response — as reflected in higher levels of antibodies — than the other vaccine combinations against the SARS-CoV-2 variant. It also triggered a stronger antibody response against all four influenza strains compared with Fluarix, and three influenza subtypes — H1N1, H3N2 and Victoria — compared with Fluzone. While the individual components of the new vaccine have been tested in individuals ages 18 to 49, the latest clinical trial for mRNA-1083 did not include this population. "It was done in people who are at the highest risk of getting in trouble medically [from both the flu and COVID-19]," said Dr. Robert Schooley, an infectious-disease specialist at the University of California, San Diego. "But it doesn't mean that if you're under 50, you don't want to get a booster shot." Everyone 6 months and older is recommended to get an updated COVID-19 shot when new ones become available, typically on an annual basis. In a recent statement, Moderna announced that the company is deprioritizing further research on mRNA-1083 testing in adults ages 18 to 49. In the same announcement, the company cited an effort to reduce its operational expenses as a factor in the decision. It is unclear if or when the company might resume testing in this age group. Based on the clinical trial results, the likelihood of mild side effects — such as fever, fatigue and chills — was higher with the combination vaccine than with the currently available vaccines given separately. "These are expected. The side effect is actually your immune system waking up, and likely shows that you'll get a very durable response," Chin-Hong said. He also added that serious side effects are very uncommon for both the already-approved COVID and flu shots and in the trials of the new combo vaccine. There were no serious side effects related to the new vaccine, the trial runners reported. Moderna initially applied for FDA approval back in 2024, using the preliminary results from the same Phase 3 trial. At the time, the FDA asked for more data to show efficacy against the flu. With more data in hand, the company is now "targeting approval" for the vaccine in 2026, according to a recent statement. However, when it comes to mRNA vaccines, both scientific and political factors are at play, Chin-Hong said. "The science is unmistakable: it [mRNA] is very nimble; it is durable; it is effective in general," he said. But he pointed out that mRNA vaccine technology itself has been the target of political criticism in the U.S. that traces back to the COVID-19 pandemic, when the vaccines' development was expedited and safety concerns were raised. Even though mRNA vaccines have proved to be very safe and effective, this history may pose a barrier to FDA approval of the new combination vaccine, Chin-Hong said. In addition, the existence of already-approved separate vaccines for flu and COVID-19 may lessen the urgency in getting the mRNA-1083 approved, he added. Research funding through the National Institutes of Health (NIH) has been widely cut or frozen, and research on vaccine hesitancy and the boosting of vaccination rates was specifically affected. Experts told NPR that they're concerned mRNA research will soon face similar cuts. NIH officials were cautioned to keep the term "mRNA" out of grant applications, KFF reported. There are also uncertainties about whether mRNA-1083 will be subject to the new framework on vaccine approval. On May 1, a Department of Health and Human Services spokesperson told The Washington Post that "all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure." A placebo is an inert or inactive substance, such as a saline shot, that new vaccines would have to be compared against during a clinical trial. Many trials of brand-new vaccines already include placebos. But when there are already existing and effective vaccines for a given disease, comparing a new shot against a placebo isn't necessarily helpful or ethical. Scientists want to understand how much better the new shot works compared with the previous one. "I don't think it's ethical to give someone a shot that is a placebo, that can in no way help them, when you know there's an existing technology that can," said Dr. Paul Offit, a virologist, immunologist and director of the Vaccine Education Center at Children's Hospital of Philadelphia. RELATED STORIES —2-in-1 shot for flu and COVID shows promise in advanced trial —The US is having its most active flu season in 15 years —Is it COVID or the flu? At-home tests can look for both viruses at once Because mRNA-1083 is a modified version of an already-approved vaccine, "I'm not sure whether that counts as new," Offit said. He thinks a placebo-controlled trial would not be appropriate in this case. Although the new combo shot still awaits approval, Gandhi said the current clinical trial results were "already convincing." The Phase 3 clinical trial demonstrated that the vaccine is safe and triggers a robust immune response, she added. "I don't see any red flags at this point," Schooley said. "I'd be confident to take the vaccine myself."
Yahoo
08-04-2025
- Health
- Yahoo
Anti-vaccine sentiment may derail vaccines already awaiting FDA approval, experts fear
Concern is growing among public health experts that anti-vaccine sentiment within federal and state governments may derail emerging and cutting-edge vaccines that are now awaiting regulatory approval in the United States – essentially leaving those vaccines in limbo. Just last week, the US Food and Drug Administration delayed a decision on full approval of Novavax's Covid-19 vaccine even though it was on track to be cleared, leaving many public health experts wondering why. A person familiar with the situation told CNN that the FDA is seeking more data on the vaccine, which has been available under emergency use authorization since 2022. It was the first Covid-19 vaccine to come up for FDA action since the second Trump administration took office in January. The surprise delay is casting new uncertainty on the fate of another vaccine awaiting FDA action: Moderna's next-generation Covid-19 shot, called mRNA-1283, which is set for a decision by May 31. The company has also filed for FDA approval of its flu+Covid combination vaccine, mRNA-1083. If approved, it will be the first in the US to offer protection against flu and Covid-19 in a single shot. Seasonal flu shots and Covid-19 vaccines are recommended each respiratory virus season, which comes over the fall and winter. These vaccines can be given at the same time, but they come in separate formulations and packaging. Vaccine makers have been developing shots that combine them in an effort to make vaccination more efficient. Moderna intends to make all three vaccines – seasonal flu shots, Covid-19 shots and the new combination vaccines – available as it's able, Dr. Rituparna Das, the company's vice president of respiratory development, said in an email. In June, Moderna released trial data showing that the combo shot, mRNA-1083, was safe and elicited higher immune responses against influenza virus and the coronavirus than currently licensed seasonal flu and Covid-19 vaccines in adults 50 and older. 'We are excited about the potential for 1083 as a combination vaccine that could improve protection against flu and COVID in a single shot,' Das wrote. 'For the past several years, it has been these two respiratory viruses which caused challenges for hospital systems in the fall.' Combination vaccines are already common in pediatrics, for instance, where the measles-mumps-rubella (MMR) vaccine is widely used and the DTaP vaccine can prevent diphtheria, tetanus and pertussis in a single jab. And Moderna isn't the only company developing a flu+Covid combination shot. Pfizer and BioNTech have teamed up to develop an influenza and Covid-19 combination vaccine that uses mRNA technology, starting multiple clinical trials evaluating updated formulations. Novavax intends to seek a business partner to continue the research and development of its influenza and Covid-19 combination vaccine candidate, which is protein-based rather than mRNA-based. 'We know that significant market demand exists for a combination product, with greater than 60% of consumers stating a preference for an all-in-one option,' Silvia Taylor, executive vice president and chief corporate affairs and advocacy officer at Novavax, said in an email. But when it comes to these new and emerging vaccines, there are mounting concerns that they may face the same fate as Novavax's Covid-19 vaccine: delayed regulatory action. Unlike Novavax's Covid-19 shot, which uses traditional protein-based technology, Moderna's mRNA-1283 Covid-19 vaccine and the flu+Covid combination vaccines being developed by Moderna and Pfizer/BioNTech are mRNA vaccines. This means they harness a modified version of messenger RNA – a molecule that tells cells what to do based on the information contained in DNA – to direct cells to produce proteins that help the immune system recognize and defend against a particular pathogen: in this case, flu viruses and the coronavirus that causes Covid-19. MRNA technology is already used in Moderna's and Pfizer/BioNTech's currently licensed Covid-19 vaccines, which have been found to be safe and effective. There is growing concern among public health experts about whether anti-vaccine sentiments – as well as bills to ban shots that use mRNA technology – may block people from accessing not only a flu+Covid vaccine but any vaccine, said Lori Tremmel Freeman, chief executive officer at the National Association of County and City Health Officials. 'I absolutely believe the environment is ripe for more jurisdictions to pick up those kinds of pieces of legislation,' Freeman said. 'It is a dangerous way to go,' she said. 'Low vaccination rates create the perfect environment for the spread of infectious disease.' Dr. Peter Hotez, co-director of the Texas Children's Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, also worries about anti-vaccine sentiments in politics as well as how mRNA vaccines specifically have been attacked. 'This is playing out now in some state legislatures that are trying to ban mRNA vaccines because of disinformation from the anti-vaccine lobby saying that they integrate into our DNA, that they cause turbo cancers, that they inflate the side effects,' Hotez said. Lawmakers in some states have introduced measures to ban the administration of mRNA vaccines, such as Montana, where a bill was defeated; Iowa and Idaho, where measures have advanced to committee; and Texas, where bills are pending or under review. At the federal level, the Trump administration is looking to evaluate mRNA research and technology and ensure transparency, according to an administration official. The US Department of Health and Human Services has also asked the US Centers for Disease Control and Prevention to study vaccines and autism, a person familiar with the situation told CNN in March, despite strong evidence that vaccines do not cause autism. And Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, who was instrumental in the development and authorization of mRNA vaccines during the Covid-19 pandemic, was forced out of the agency this month. At the National Institutes of Health, some officials reportedly have urged scientists to remove references to mRNA vaccine technology from their grant applications, suggesting that the agency might abandon that area of research, according to KFF Health News. 'Researchers have been exploring mRNA's potential in medicine for over 30 years,' Moderna spokesperson Jenna Sexton said in an email, adding that more than a billion doses of mRNA vaccines have been distributed worldwide and 'an unprecedented amount of real-world safety and efficacy data' is well-established. 'Legislative efforts to ban or restrict mRNA medicines in various states are largely driven by misunderstandings about their well-established safety profile and mechanism of action,' Sexton said. 'For example, while mRNA does not modify DNA, this misconception is frequently cited in support of such policies. If enacted, these measures could hinder important research and limit patient access to innovative treatments, potentially delaying life-changing medical advancements.' This trend of lawmakers pushing to ban the use of mRNA technology is 'striking' and suggests that scientists and doctors could do a 'better job' of communicating with the general public, public health officials and lawmakers about the overall benefits and risks of mRNA medicines, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center. 'A complete ban on a technology would be a very striking move, as opposed to exploring a concern with a particular product. It's like saying that there is something that you dislike about a website, so you're going to ban the entire Internet,' Barouch said. 'MRNA technology is used for many things, not just infectious disease vaccines. There are cancer therapies that are being developed,' he added. 'There's gene editing and gene therapies that are being developed.' Some public health experts argue that scrutiny around mRNA technology is an extension of anti-vaccine sentiments in politics. 'I think that was kind of a false notion that people had – that there's hesitancy around the mRNA vaccine, and those people will get a protein-based vaccine. They didn't,' said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. 'They didn't get the J&J vaccine very much when it was available, and they didn't get the Novavax vaccine, which has been available since the EUA was issued,' he said. 'You have to think about this as no vaccine being safe in this administration, in terms of from political interference.' If a flu+Covid combination vaccine does eventually get FDA approval, it might help improve vaccination rates because 'you only have to roll up one sleeve to get your vaccine, and you can get two at the same time and get good, solid protection as recommended,' said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center. But he added that it could still take some time before combination vaccines are ordered and rolled out to the general public, as they would have to be licensed under the FDA and then recommended by the CDC as part of the routine seasonal vaccination schedule. Most doctor's offices, clinics, hospitals, health departments and pharmacies are gearing up to place orders for seasonal flu and Covid-19 vaccines for the 2025-26 virus season, as preorders typically begin around March, Schaffner said. The vaccines are usually delivered starting around August. 'The combination vaccines may or may not become available for this fall,' Schaffner said. 'The ordering takes place months before we start administering the vaccine, and that, of course, allows the manufacturers to get a sense of how much vaccine to manufacture. So it's a complicated process.' Some vaccine experts argue that mRNA technology can speed up that process. When it comes to the composition of flu shots, the use of mRNA vaccination against influenza 'is still not well-established, except in experimental studies,' Hotez said, so using mRNA technology in flu+Covid combination vaccines 'would establish proof of concept.' 'If that gets shown, that could be a big breakthrough,' he said. 'Because it means that we could perhaps shorten the period required for making influenza vaccines as we get closer to flu seasons and have a better match between circulating viruses and the vaccine.' The currently licensed seasonal flu shots, which are not mRNA-based, are developed months in advance because they're updated each year to target whichever strain is expected to circulate the most, and they take some time to manufacture. By the time the vaccines are given, the flu strains they are updated to target may no longer be dominant. 'But you can make a piece of mRNA very quickly, and possibly closer to the actual fall-winter flu season,' Hotez said. 'As a result, you might be able to reduce the time frame required to make the decision on what goes into the flu vaccine,' he said. 'With mRNA, we could delay that decision on what goes into the vaccine – maybe for a couple of months, until May or so – until we have a better idea of what's circulating. So there could be some advantage there.'
CNN
08-04-2025
- Health
- CNN
Anti-vaccine sentiments may derail vaccines already awaiting FDA approval, experts fear
Concern is growing among public health experts that anti-vaccine sentiment within federal and state governments may derail emerging and cutting-edge vaccines that are now awaiting regulatory approval in the United States – essentially leaving those vaccines in limbo. Just last week, the US Food and Drug Administration delayed a decision on full approval of Novavax's Covid-19 vaccine even though it was on track to be cleared, leaving many public health experts wondering why. A person familiar with the situation told CNN that the FDA is seeking more data on the vaccine, which has been available under emergency use authorization since 2022. It was the first Covid-19 vaccine to come up for FDA action since the second Trump administration took office in January. The surprise delay is casting new uncertainty on the fate of another vaccine awaiting FDA action: Moderna's next-generation Covid-19 shot, called mRNA-1283, which is set for a decision by May 31. The company has also filed for FDA approval of its flu+Covid combination vaccine, mRNA-1083. If approved, it will be the first in the US to offer protection against flu and Covid-19 in a single shot. Seasonal flu shots and Covid-19 vaccines are recommended each respiratory virus season, which comes over the fall and winter. These vaccines can be given at the same time, but they come in separate formulations and packaging. Vaccine makers have been developing shots that combine them in an effort to make vaccination more efficient. Moderna intends to make all three vaccines – seasonal flu shots, Covid-19 shots and the new combination vaccines – available as it's able, Dr. Rituparna Das, the company's vice president of respiratory development, said in an email. In June, Moderna released trial data showing that the combo shot, mRNA-1083, was safe and elicited higher immune responses against influenza virus and the coronavirus than currently licensed seasonal flu and Covid-19 vaccines in adults 50 and older. 'We are excited about the potential for 1083 as a combination vaccine that could improve protection against flu and COVID in a single shot,' Das wrote. 'For the past several years, it has been these two respiratory viruses which caused challenges for hospital systems in the fall.' Combination vaccines are already common in pediatrics, for instance, where the measles-mumps-rubella (MMR) vaccine is widely used and the DTaP vaccine can prevent diphtheria, tetanus and pertussis in a single jab. And Moderna isn't the only company developing a flu+Covid combination shot. Pfizer and BioNTech have teamed up to develop an influenza and Covid-19 combination vaccine that uses mRNA technology, starting multiple clinical trials evaluating updated formulations. Novavax intends to seek a business partner to continue the research and development of its influenza and Covid-19 combination vaccine candidate, which is protein-based rather than mRNA-based. 'We know that significant market demand exists for a combination product, with greater than 60% of consumers stating a preference for an all-in-one option,' Silvia Taylor, executive vice president and chief corporate affairs and advocacy officer at Novavax, said in an email. But when it comes to these new and emerging vaccines, there are mounting concerns that they may face the same fate as Novavax's Covid-19 vaccine: delayed regulatory action. Unlike Novavax's Covid-19 shot, which uses traditional protein-based technology, Moderna's mRNA-1283 Covid-19 vaccine and the flu+Covid combination vaccines being developed by Moderna and Pfizer/BioNTech are mRNA vaccines. This means they harness a modified version of messenger RNA – a molecule that tells cells what to do based on the information contained in DNA – to direct cells to produce proteins that help the immune system recognize and defend against a particular pathogen: in this case, flu viruses and the coronavirus that causes Covid-19. MRNA technology is already used in Moderna's and Pfizer/BioNTech's currently licensed Covid-19 vaccines, which have been found to be safe and effective. There is growing concern among public health experts about whether anti-vaccine sentiments – as well as bills to ban shots that use mRNA technology – may block people from accessing not only a flu+Covid vaccine but any vaccine, said Lori Tremmel Freeman, chief executive officer at the National Association of County and City Health Officials. 'I absolutely believe the environment is ripe for more jurisdictions to pick up those kinds of pieces of legislation,' Freeman said. 'It is a dangerous way to go,' she said. 'Low vaccination rates create the perfect environment for the spread of infectious disease.' Dr. Peter Hotez, co-director of the Texas Children's Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, also worries about anti-vaccine sentiments in politics as well as how mRNA vaccines specifically have been attacked. 'This is playing out now in some state legislatures that are trying to ban mRNA vaccines because of disinformation from the anti-vaccine lobby saying that they integrate into our DNA, that they cause turbo cancers, that they inflate the side effects,' Hotez said. Lawmakers in some states have introduced measures to ban the administration of mRNA vaccines, such as Montana, where a bill was defeated; Iowa and Idaho, where measures have advanced to committee; and Texas, where bills are pending or under review. At the federal level, the Trump administration is looking to evaluate mRNA research and technology and ensure transparency, according to an administration official. The US Department of Health and Human Services has also asked the US Centers for Disease Control and Prevention to study vaccines and autism, a person familiar with the situation told CNN in March, despite strong evidence that vaccines do not cause autism. And Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, who was instrumental in the development and authorization of mRNA vaccines during the Covid-19 pandemic, was forced out of the agency this month. At the National Institutes of Health, some officials reportedly have urged scientists to remove references to mRNA vaccine technology from their grant applications, suggesting that the agency might abandon that area of research, according to KFF Health News. 'Researchers have been exploring mRNA's potential in medicine for over 30 years,' Moderna spokesperson Jenna Sexton said in an email, adding that more than a billion doses of mRNA vaccines have been distributed worldwide and 'an unprecedented amount of real-world safety and efficacy data' is well-established. 'Legislative efforts to ban or restrict mRNA medicines in various states are largely driven by misunderstandings about their well-established safety profile and mechanism of action,' Sexton said. 'For example, while mRNA does not modify DNA, this misconception is frequently cited in support of such policies. If enacted, these measures could hinder important research and limit patient access to innovative treatments, potentially delaying life-changing medical advancements.' This trend of lawmakers pushing to ban the use of mRNA technology is 'striking' and suggests that scientists and doctors could do a 'better job' of communicating with the general public, public health officials and lawmakers about the overall benefits and risks of mRNA medicines, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center. 'A complete ban on a technology would be a very striking move, as opposed to exploring a concern with a particular product. It's like saying that there is something that you dislike about a website, so you're going to ban the entire Internet,' Barouch said. 'MRNA technology is used for many things, not just infectious disease vaccines. There are cancer therapies that are being developed,' he added. 'There's gene editing and gene therapies that are being developed.' Some public health experts argue that scrutiny around mRNA technology is an extension of anti-vaccine sentiments in politics. 'I think that was kind of a false notion that people had – that there's hesitancy around the mRNA vaccine, and those people will get a protein-based vaccine. They didn't,' said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. 'They didn't get the J&J vaccine very much when it was available, and they didn't get the Novavax vaccine, which has been available since the EUA was issued,' he said. 'You have to think about this as no vaccine being safe in this administration, in terms of from political interference.' If a flu+Covid combination vaccine does eventually get FDA approval, it might help improve vaccination rates because 'you only have to roll up one sleeve to get your vaccine, and you can get two at the same time and get good, solid protection as recommended,' said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center. But he added that it could still take some time before combination vaccines are ordered and rolled out to the general public, as they would have to be licensed under the FDA and then recommended by the CDC as part of the routine seasonal vaccination schedule. Most doctor's offices, clinics, hospitals, health departments and pharmacies are gearing up to place orders for seasonal flu and Covid-19 vaccines for the 2025-26 virus season, as preorders typically begin around March, Schaffner said. The vaccines are usually delivered starting around August. 'The combination vaccines may or may not become available for this fall,' Schaffner said. 'The ordering takes place months before we start administering the vaccine, and that, of course, allows the manufacturers to get a sense of how much vaccine to manufacture. So it's a complicated process.' Some vaccine experts argue that mRNA technology can speed up that process. When it comes to the composition of flu shots, the use of mRNA vaccination against influenza 'is still not well-established, except in experimental studies,' Hotez said, so using mRNA technology in flu+Covid combination vaccines 'would establish proof of concept.' 'If that gets shown, that could be a big breakthrough,' he said. 'Because it means that we could perhaps shorten the period required for making influenza vaccines as we get closer to flu seasons and have a better match between circulating viruses and the vaccine.' The currently licensed seasonal flu shots, which are not mRNA-based, are developed months in advance because they're updated each year to target whichever strain is expected to circulate the most, and they take some time to manufacture. By the time the vaccines are given, the flu strains they are updated to target may no longer be dominant. 'But you can make a piece of mRNA very quickly, and possibly closer to the actual fall-winter flu season,' Hotez said. 'As a result, you might be able to reduce the time frame required to make the decision on what goes into the flu vaccine,' he said. 'With mRNA, we could delay that decision on what goes into the vaccine – maybe for a couple of months, until May or so – until we have a better idea of what's circulating. So there could be some advantage there.'
