Latest news with #MonicaGandhi
Medical News Today
08-07-2025
- Health
- Medical News Today
Vaccine additive thimerosal deemed unsafe by the CDC: 3 things to know
The United States federal government may soon ban vaccines that use an ingredient called is a preservative that — due to questions about its safety throughout the decades — has mostly been avoided by vaccine it still features in some flu shots, which has prompted questions about how a potentially impending ban on thimerosal may affect vaccine availability and June 24, 2025, an advisory committee for the Centers for Disease Control and Prevention (CDC) voted against the use of an additive called thimerosal in their presentation, the advisory panel called thimerosal 'a known neurotoxin' and advised that banning vaccines using this ingredient would be 'a good place to start with Making America Healthy Again.'Thimerosal is an additive used as a preservative — that is, a substance that helps keep the active ingredients in vaccines fresh and why is it controversial, and what do we really know about its safety?Medical News Today examined what is known about thimerosal's current use and safety profile and answered these and other questions with the assistance of Monica Gandhi, MD, MPH, an infectious disease specialist and professor of medicine at the University of California, San is thimerosal a controversial vaccine ingredient?'Thimerosal is a mercury-based preservative that can help vaccines last longer,' Gandhi is precisely what renders it controversial, since, as the World Health Organization (WHO) notes, mercury is a liquid metal that poses various risks to human can affect a number of bodily systems, including the nervous system, digestive system, immune system, the lungs, kidneys, skin, and 'high levels of mercury can be toxic to a developing fetus, for eample,' Gandhi pointed this reason, she added, 'thimerosal has been taken out of most childhood vaccines but can still be found in some including the multidose influenza vaccine.'However, thimerosal contains a very specific, modified form of mercury called ethylmercury, which, according to the WHO, 'does not pose a health risk,' as it quickly breaks down after entering the body, and is subsequently thimerosal cause autism or neurodevelopmental conditions?Another part of the thimerosal controversy is the fact that it was mistakenly linked to autism by a now-discredited and retracted study.'Multiple studies have shown no safety concerns with thimerosal in terms of causing autism or neurodevelopmental issues,' said Gandhi. The advisory panel calling for thimerosal's ban appeared to further fuel the controversy by citing a publication whose alleged author has since explained in media interviews does not exist, leading to its removal from the presentation.'[T]his reference —showing an association between thimerosal and neurodevelopmental delays in animals — did not exist and was subsequently removed from the presentation when the error was pointed out,' Gandhi to Reuters, Katherine L. O'Brien, MD, MPH, director of the Department of Immunization, Vaccines, and Biologicals at the WHO, emphasized that, based on current medical evidence, the organization finds thimerosal thimerosal considered safe?'Thimerosal has been reviewed multiple times by multiple agencies, including WHO, and it's clear from the evidence that there is no evidence of harm from the use of thimerosal.'— Katherine L. O'Brien, MD, MPHHow might banning thimerosal affect vaccine availability?While it is largely considered safe, in the U.S., thimerosal is already rarely used in vaccines. In 1999, the American Academy of Pediatrics and the U.S. Public Health Service issued a call to remove thimerosal from most childhood ingredient has thus been avoided, as a precautionary measure, since 2001, according to the only exception to this, as Gandhi pointed out, is the multidose flu shot. 'Before we knew thimerosal was safe in multiple animal and human studies, it was removed from almost all childhood vaccines. However, thimerosal is still in influenza vaccine, especially the ones that come in multidose vials, since the agent serves as powerful preservative protecting the vaccine from bacterial or fungal contamination.'— Monica Gandhi, MD, MPHThe greatest concern with banning thimerosal entirely is that this action could severely affect vaccine availability in the community.'Banning thimerosal is simply not indicated by the scientific evidence,' Gandhi insisted.'Moreover, this could result in less stock of influenza vaccine being produced or a move away from the multidose vials, which could limit vaccine availability of the flu vaccine this coming respiratory season,' she told to national immunization data provided by the CDC, flu vaccinations among children in the U.S. are already on the decline, even as flu cases were surging significantly during the last flu these shots become less available during the next flu season, this viral infection, which is typically easily kept at bay, could cause more severe issues among the to the CDC, the flu can cause serious complications in young children, including pneumonia and inflammation of the brain (encephalitis).
Medical News Today
30-06-2025
- Health
- Medical News Today
How to stay safe against measles while traveling: Expert advice
Measles is an airborne disease that is very transmissible and may spread easily and rapidly on a plane, bus, or United States and some other countries have recently seen a rise in measles cases and Centers for Disease Control and Prevention has urged people traveling internationally to ensure they are vaccinated against travelers may need boosters if they received inactivated forms of the measles vaccine or only one cases have been on the rise in recent months, and infection poses serious health risks, yet discussion about how to protect more vulnerable groups has been a highly contagious viral disease, measles poses a particular risk to children, older adults, people who are unvaccinated, and immunocompromised individuals. However, another group that is at high risk is of the closed space and recycled air breathing, travelers can be at heightened risk of contracting viruses, such as in the case of Centers for Disease Control and Prevention (CDC) recently issued updated advice to people traveling internationally, urging everyone to get fully vaccinated and monitor their health to prevent further spread of the News Today spoke to two experts — Monica Gandhi, MD, MPH, an infectious disease specialist with the University of California, SF, and David Cutler, MD, a board-certified family medicine physician at Providence Saint John's Health Center in Santa Monica, CA, to learn more about how measles spreads and what measures travelers can take to stay safe and minimize their risk of measles infectious is measles?Much like COVID-19, measles spreads via respiratory droplets expelled when a person with a measles infection coughs or sneezes. It can also spread via touch, with a person touching their mouth, nose, or eyes after having touched surfaces contaminated with these virus that causes measles can also remain active and contagious in the air or on surfaces for up to 2 hours.'Measles is one of the most infectious viruses known. After being exposed, 90% of susceptible people become infected. However, since infection offers lifelong protection, and immunization is 93–97% effective, there has always been the hope that this disease could be eradicated,' Cutler how does one determine how much at risk they are for measles?'The risk of an individual acquiring measles depends on their susceptibility, the presence of active measles cases, and gaining proximity to someone with measles,' Cutler may help travelers to determine their individual risk is considering their vaccination status, health conditions, as well as knowing current global hotspots for measles high risk areas can help minimize infection risk. CDC Travel Health Notices and WHO Disease Outbreak News could be good sources to traveling via plane or bus constitute a big risk?Considering how measles is transmitted, we asked our experts how much of a risk traveling via bus, train, or plane told MNT that, since the measles virus is airborne, it can remain in the air for a substantial amount of time 'after the person infected with measles has left.''Therefore, traveling during an outbreak can constitute a risk since these modes of transportation are most often sealed off without ventilation,' she pointed of all classic modes of transport, planes may be associated with the highest risk of infection due to the fact that travelers have to remain in close quarters to each other for prolonged periods of time.'Traveling by bus, train, plane, or automobile could expose you to measles if you are in close proximity to someone who is infected. Keeping distant from other people, avoiding those who might be infected, and staying away from communities with known measles outbreaks may reduce the risk of infection,' Cutler measures can travelers take to protect themselves?Both experts agreed on one measure that is scientifically proven to protect people against infection with measles: getting vaccinated.'The best way to protect yourself from measles is to be vaccinated,' Gandhi MMR vaccine has been proven to offer lifelong protection against measles with two doses, and breakthrough cases are rare and should aim to carry evidence of their vaccination status, especially if they are traveling to a high-risk area. In terms of timing, they should aim to get vaccinated at least two weeks before their travel.1. MMR vaccine: When to get vaccinated against measlesInfants ages 6–11 months should receive an early dose of the vaccine before they travel, and then follow the routine vaccination schedule. Children older than 12 months should receive their first dose now, and the second dose at least 28 days later. Teenagers or adults without immunity against measles should get two doses of the MMR vaccine, 28 days apart.2. Face masks and personal hygieneCutler said that as measles is spread by airborne transmission, one way people can protect themselves is by wearing an N95 mask, especially indoors or in places of good hygiene such as washing hands thoroughly, avoiding touching one's face, and using hand sanitizer can also minimize the risk of also touched on the importance of proper ventilation and personal safety measures such as masking, as additional layers of protection after getting vaccinated.'Since measles is airborne, ventilation is very protective so sitting next to open window on a bus or train is also [somewhat] protective. For those who are vulnerable, a tight-fitting and filtering mask, such as an N95 or K95 mask, can protect from measles,' she to do if you've been exposed to measles during travelPeople with measles typically experience high fever, cough, runny nose, red eyes, and a distinctive rash that starts to develop about three to five days after the initial symptoms appear. The incubation period for measles is generally between seven and 14 days from exposure, though this can go up to 21 days. Experts recommend that people who have been in contact with someone with measles should get in touch healthcare providers as soon as possible and isolate themselves to prevent the disease from spreading local health clinics and learning a few basic phrases to describe symptoms may help travelers feel more at ease if they start feeling unwell.'People with measles should isolate themselves, wear a strong fit and filtered mask and present to a medical facility so that supportive care can be provided if needed and contact tracing initiated to trace the origin of the infection (and to ensure that others who were exposed to measles do not get infected or are treated),' said measles can lead to various health complications such as pneumonia, encephalitis (inflammation of the brain), ear infections and, in severe cases, long-term neurological issues or even death if left untreated, experts advise people to seek immediate medical explained for MNT that:'Once infected with measles there is no effective cure. Treatment for someone with measles is simply supportive: maintaining adequate hydration, good nutrition and control of fever. There is about a 1 [in] 1,000 risk of dying if infected with measles. So, while hospitalization may not be necessary, it is a good idea to seek medical attention if you might have measles to confirm the diagnosis, eliminate the possibility of an infection which might mimic measles, and to assure that anyone you have exposed has the opportunity to gain appropriate protection,' Vitamin A, when administered by healthcare professionals, can help lessen the severity of disease. However, experts agree that it is not a substitute for people who are unvaccinated, the first 72 hours may also be crucial in terms of disease progression. To that extent, Cutler talked about two strategies that may help reduce risk.'For individuals who are not protected by vaccination or prior infection, infection after exposure can best be prevented by administering the vaccine within three days of exposure,' Cutler said.'Intramuscular or intravenous immune globulin is another option. This is generally reserved for infants under 6 months of age, pregnant women, and those who are 3–6 days after exposure. For these people, vaccination to prevent infection is not recommended,' he should also monitor their health for three weeks after they return home from their travels, and watch out for symptoms such as a rash, fever, confusion, and breathing problems.
Health Line
29-05-2025
- Business
- Health Line
CDC, FDA Limit Access to COVID Shots for Healthy Adults, Kids, and Pregnant People
Trump administration officials say they will no longer recommend the COVID-19 vaccine for people under 65, pregnant people, and healthy children. Updated COVID-19 vaccines are now required to undergo placebo-controlled clinical trials prior to approval, which could limit access to shots. Experts say it's shortsighted to exclude pregnant people and children from the list of recommended groups who should get vaccinated against COVID-19. If you're under 65 and healthy, it may be difficult for you to get a COVID-19 vaccination this fall. In a post on X, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Centers for Disease Control and Prevention (CDC) will no longer recommend updated COVID-19 shots for healthy pregnant people and healthy children. The change in the CDC recommendation comes after officials at the Food and Drug Administration (FDA) stated in a New England Journal of Medicine paper that the agency planned to reserve COVID-19 vaccines for older adults and for children and adults with underlying medical conditions. 'Although the rapid development of multiple COVID-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment, the benefit of repeat dosing — particularly among low risk persons who may have previously received multiple doses of COVID-19 vaccines, had multiple COVID-19 infections, or both — is uncertain,' they wrote. Monica Gandhi, MD, a professor of medicine at the University of California San Francisco, agreed that not everyone needs to be vaccinated, but she would like to see more people included in the recommendations for those who need updated COVID-19 shots. 'I would have preferred that the guidance did not name healthy pregnant women as not needing the shot,' Gandhi told Healthline. 'I agree that healthy children with previous immunity (either from vaccination or previous infection) do not need COVID-19 vaccinations, but I would prefer children without previous immunity to get the COVID-19 vaccine,' she said. In addition, FDA officials have told drug manufacturers that they should update their COVID-19 vaccines to target the LP.8.1 strain, an offshoot of the Omicron variant that was first detected in July 2024. However, the FDA officials added that they want new vaccines to undergo placebo-controlled clinical trials, a procedure recent vaccine updates haven't gone through. That means it could take years for new vaccines to be approved. Gandhi said she has some ethical concerns with this policy. 'The original COVID-19 vaccine trials (such as with the Moderna or Pfizer vaccines) used a placebo-controlled design because there was no prior COVID-19 vaccine, so using a placebo as a comparison was ethical,' she explained. 'However, we now have COVID-19 vaccines, and it would not be ethical to compare a new COVID-19 vaccine with a placebo in a vulnerable individual (e.g., an older person) when their control could be a prior COVID-19 vaccine formulation.' COVID shots during pregnancy protect against severe illness On its website, the CDC still lists pregnancy as one of the underlying conditions (along with asthma, cancer, kidney disease, diabetes, and other conditions) that can put a person at higher risk of a severe COVID-19 illness. In addition, a study published in April 2025 reported that maternal mortality in the United States remained relatively constant from 2000 to 2020 until it spiked in 2021 during the height of the COVID-19 pandemic. It's also been reported that COVID-19 can increase the risk of pregnancy complications and that pregnant people have a higher risk of becoming seriously ill from the disease. G. Thomas Ruiz, MD, lead OB-GYN at MemorialCare Orange Coast Medical Center in California, said one reason for these higher risks is that a person becomes immunocompromised during pregnancy. 'The new recommendations are ludicrous,' he told Healthline. 'They are shortsighted and irresponsible.' Officials at the American College of Obstetricians and Gynecologists (ACOG) agreed. 'ACOG is concerned about and extremely disappointed by the announcement that HHS will no longer recommend COVID-19 vaccination during pregnancy,' said Steven Fleischman, MD, the president of ACOG, in a statement. 'As ob-gyns who treat patients every day, we have seen firsthand how dangerous COVID-19 infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection.' William Schaffner, MD, an infectious disease expert and a professor of medicine at Vanderbilt University in Tennessee also thinks vaccination during pregnancy is prudent. 'Not only does the vaccine protect the mother, some of that protection passes through the placenta, offering protection to the newborn infant during the first six months of life,' he told Healthline. COVID shots recommended starting at age 6 months The CDC added the COVID-19 vaccination to its recommended immunization schedule for children in 2022. The agency's website currently states that vaccination against COVID-19 can help prevent children from becoming seriously ill. COVID-19 vaccines are recommended for everyone 6 months and older. Officials at the American Academy of Pediatrics (AAP) reported in a statement that an analysis of data collected by Health and Human Services found that 11,199 children were admitted to the hospital with COVID-19 during the 2024-2025 respiratory virus season, 7,746 of whom were under age 5 years. 'By removing the recommendation, the decision could strip families of choice,' said Sean O'Leary, MD, the chair of the AAP Committee on Infectious Diseases. 'Those who want to vaccinate may no longer be able to, as the implications for insurance coverage and access remain unclear. What is clear is that pregnant women, infants, and young children are at higher risk of hospitalization from COVID, and the safety of the COVID vaccine has been widely demonstrated.' Danelle Fisher, MD, a pediatrician at Providence Saint John's Health Center in Santa Monica, CA, said she will still recommend to parents that their children get the COVID-19 vaccine. 'I personally think that these recommendations are not based in science,' Fisher told Healthline. 'COVID-19 has not gone away in these groups, and so this gives me pause.' Fisher added she is concerned that parents will see the new recommendations and decide their children don't need to be vaccinated. She is also worried that there won't be enough supply for parents who do want to vaccinate their children. 'This is a huge concern for me,' Fisher said. 'We can only recommend for what we have to give.' Can you get a COVID-19 shot this fall? The new policies will bring the United States' recommendations on COVID-19 vaccines closer to the standards in European countries. However, experts say it may mean that younger and healthier people in the United States will have trouble getting an updated shot if they want one. They point out that COVID-19 vaccine manufacturers may not produce as many shots under the new guidelines. In addition, insurance companies are unlikely to cover the cost of a vaccination for someone who doesn't meet the CDC and FDA recommendations, experts told Healthline. The CDC currently lists the price for a Pfizer or Moderna COVID-19 vaccine at about $150. However, Ruiz said the cost could rise to somewhere between $500 and $1,000. 'It could become prohibitively expensive,' he said. He fears the cost, combined with the new recommendations, could 'discourage a lot of people' from getting vaccinated. 'The vaccine should be available to anyone who wants it,' he said. Ruiz said he will continue to recommend the updated shots to his patients. Schaffner agreed that updated vaccines against COVID are still helpful, particularly during respiratory virus season. 'Certainly, everyone in a high risk group should take advantage of the protection provided by COVID vaccine this fall,' he said. 'COVID has not disappeared, and we are sure to experience a winter increase once again.' Fisher noted that vaccines for COVID-19, as well as influenza and other diseases, are simply practical choices.
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."
Business Mayor
20-05-2025
- Health
- Business Mayor
2-in-1 COVID-flu vaccine looks promising in trial — but experts say approval may be delayed
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 . You may like 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. Why do we need a combination vaccine? 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. Get the world's most fascinating discoveries delivered straight to your inbox. '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. What is in mRNA-1083? 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. Current flu shots in the U.S. guard against three broad types of flu virus. (Image credit: KATERYNA KON/SCIENCE PHOTO LIBRARY via Getty Images) '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. How did the combination vaccine perform? 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. Will the combo vaccine be tested in younger adults? 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. It's unclear whether the new vaccine may face barriers to approval, despite strong trial data. (Image credit: – Yuri A via Shutterstock) Does the combo shot have more side effects? 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. When could the vaccine be approved? 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. 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.'
