Latest news with #MartyMakary
Yahoo
21 hours ago
- Health
- Yahoo
RFK Jr. Changes Guidance for This Common Vaccine
The Center for Disease Control and Prevention (CDC) will no longer recommend COVID-19 vaccines to healthy children and healthy pregnant women, the change being justified as 'common sense.' Secretary of Health and Human Services Robert F. Kennedy Jr. made the announcement on X Tuesday in a video message with the Director of the National Institutes of Health (NIH) Dr. Jay Bhattacharya and Federal Drug Administration (FDA) Commissioner Marty Makary. 'I couldn't be more pleased to announce that, as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,' Kennedy said. He accused the Biden administration of urging healthy children to get 'yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.' 'That ends today. It's common sense and it's good science,' chirped Bhattacharya. 'There's no evidence healthy kids need it today, and most countries have stopped recommending it for children,' added Makary. 'We're now one step closer to realizing President Trump's promise to Make America Healthy Again,' Kennedy concluded. Both Kennedy and Makary teased this new development last week, Makary hinting that annual shots for healthy adults and children might not be regularly approved anymore, and Kennedy placing new restrictions on the Novavax COVID-19 vaccine. This marks a drastic shift from the CDC's previous stance on the COVID vaccine, the agency saying two weeks prior to Trump's second inauguration that they recommend that 'everyone ages 6 months and older should get a 2024–2025 COVID-19 vaccine.' But Kennedy's announcement comes before the CDC's Advisory Committee on Immunization Practices has completed its deliberations on whether or not pregnant women should remain eligible for the COVID-19 vaccine. The Committee was set to vote on the issue, among others, in June. Multiple studies have stated that pregnant women are at an increased risk from COVID, going against Kennedy's 'common sense' claim that they don't require vaccination. One study conducted by researchers at Brown University School of Public Health showed that maternal mortality spiked at the peak of COVID in 2021. Even Elon Musk's AI chatbot on X, Grok, couldn't believe its digital ears, writing that the trio's statement 'cited 'lack of clinical data' but provided no specific scientific papers.' 'A 2022 Lancet study supports vaccine safety in pregnancy, showing no adverse outcomes,' it wrote. 'Critics cite 2023 ACIP data indicating benefits across groups. Without direct HHS citations, the decision's basis remains unclear.' Leaving out healthy children and pregnant women from the CDC's recommended immunization schedule could also significantly alter existing insurance guidelines. The immunization schedule provides a guide for doctors and insurance coverage for Medicaid expansion programs and a majority of private insurance plans. All three men have been outspoken about their vaccine criticism, Makary previously claiming that the FDA and CDC 'lied to the American people' about the need for additional COVID measures such as booster shots. 'The greatest perpetrator of misinformation during the pandemic has been the United States government,' Makary said at a 2023 roundtable organized by Republicans. Last week, Bhattacharya said at a disastrous town hall with his NIH staff that it's 'possible that the NIH partly sponsored' research that he claims might have caused the COVID pandemic, prompting a walkout in protest by dozens of staffers.
Medscape
a day ago
- Business
- Medscape
CDC Drops Guidance for COVID Vaccines for Pregnancy
The US Centers for Disease Control and Prevention (CDC) has just updated its child and adolescent immunization schedule in a way that states that parents who want to vaccinate healthy children could do so, based on shared decision making with a clinician. The agency also updated the adult immunization schedule to say there is 'no guidance' on use in pregnancy. The update for children and adolescents seems to contradict the May 27 announcement on COVID vaccines by Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. In a 58-sec video posted to X, Kennedy said the COVID vaccine was 'being removed from the CDC-recommended immunization schedule' for healthy pregnant women and also for healthy children. US Food and Drug Administration Commissioner Marty Makary, MD, said on the video that 'there's no evidence healthy kids need it today,' while National Institutes of Health Director Jay Bhattacharya, MD, called the move 'good science.' As of press time, HHS had not issued a formal proposal or written policy to further detail the announcement, but the CDC had change its online immunization schedules. The see-sawing of the policy announcements — without any public meetings or input — have left clinicians perplexed and fearful about availability of the COVID-19 vaccine for healthy pregnant women and healthy children in advance of what is typically a surge of infections during the summer and fall months in the US. Linda Eckert, MD, a professor of obstetrics and gynecology at the University of Washington in Seattle, said she was 'horrified' when she heard the announcement. 'I was just like, why did this happen?' she told Medscape Medical News . COVID during pregnancy 'is dangerous to my patients, and when my patients don't do well, their pregnancies don't do well,' Eckert said. The virus is also very dangerous to infants during the first 6 months of life, 'and maternal antibody transfer is the way that those infants are protected,' said Eckert, a member of the American College of Obstetricians and Gynecologists (ACOG) immunization committee. The announcement prompts questions, but not many answers, she said. 'What are we going to do with our patients? How are we going to have these conversations now?' said Eckert. 'We're all trying to read the tea leaves as to what [Kennedy] really means,' said Paul Offit, MD, director of the Vaccine Education Center at Children's Hospital of Philadelphia, Leaving clinicians, insurers, and patients to guess is 'a wholly irresponsible way to do business,' Offit told Medscape . Offit said that Kennedy has made no secret of his intent to focus on chronic disease while reducing resources for infectious disease. The Secretary 'has for 20 years been an anti-vaccine activist and science denialist,' said Offit. 'He's basically doing what he can to tear down the vaccine infrastructure in this country,' he said. Alarms Sounded Many professional organizations expressed alarm at Kennedy's announcement. The HHS Secretary bypassed the traditional process for vaccine recommendations, which includes discussion of evidence for safety and effectiveness at open public meetings held by the CDC's Advisory Committee on Immunization Practices (ACIP). ACIP then makes a recommendation, which the CDC director approves or disapproves. 'It is concerning that such a significant policy change was made unilaterally outside an open, evidence-based process with no regard for the negative impact this will have on millions of Americans,' said Tina Tan, MD, president of the Infectious Diseases Society of America, in a statement. 'By removing the recommendation, the decision could strip families of choice,' said Sean O'Leary, MD, chair of the American Academy of Pediatrics' Committee on Infectious Diseases, in a statement. 'Those who want to vaccinate may no longer be able to, as the implications for insurance coverage remain unclear,' he said. 'It's also unclear whether healthcare workers would be eligible to be vaccinated.' O'Leary said that the evidence shows that pregnant women, infants, and young children are at higher risk of hospitalization from COVID and that the vaccine's safety 'has been widely demonstrated.' 'Despite the change in recommendations from HHS, the science has not changed,' said ACOG President Steven J. Fleischman, MD, in a statement. Most infants under the age of 6 months who are hospitalized for COVID are born to unvaccinated mothers, said Fleschman. Kennedy's announcement may mean pregnant people are less likely to choose to vaccinate, he said. 'We are very concerned about the potential deterioration of vaccine confidence in the future,' said Fleischman. Jason M. Goldman, MD, president of the American College of Physicians, agreed. 'The HHS announcement will likely further erode public confidence in the safety of these vaccines, despite the evidence demonstrating their benefits,' he said, in a statement. Goldman also said the policy change has 'the potential to threaten insurance coverage for COVID vaccines and boosters, increasing the cost and placing them out-of-reach of individuals who do still want to be vaccinated.' Who Will Get the COVID Vaccine? Uptake of the vaccine has been waning, even with insurance coverage. According to CDC's COVID-19 Vaccination Dashboard, 14% of pregnant women had received the 2024-25 vaccine. As of late March, just under 13% of children 6 months-to-17 years had received the vaccine, the CDC reported at the ACIP's last meeting in April. Children under 6 months have the second highest COVID-related hospitalization rates, comparable to those of adults aged 64-75; only adults aged 75 or older have higher rates, the CDC has reported. A fifth of 1000 hospitalized infants with COVID-19 during a 2-year period were admitted to an intensive care unit; nine died while hospitalized. Vaccination of mothers has led to a decline in hospitalizations, however, said the agency. Even so, 96 children under age 4 and 56 aged 5-17 died from COVID from September 2023 to August 2024, said CDC officials at the last ACIP meeting. COVID's dangers during pregnancy have been documented in many studies. Researchers from George Washington University in Washington, DC, reported in a 2023 paper that pregnant women with COVID-19 experienced 7 times greater risk of dying during pregnancy or childbirth, 3 times greater risk of being admitted to the ICU, 23 times greater risk of developing pneumonia, and 5 times greater risk of thromboembolic disease. Eckert said that, despite the dangers, fewer patients have been opting for vaccination over the last few years 'because people view COVID as less of a threat.' She still talks to patients about protection. The new recommendation is going to make it more difficult to help patients stay safe, she said. Meanwhile, as reported by Medscape , the FDA announced earlier in May that it would be calling for more studies of COVID vaccines in healthy Americans and that it would recommend against approval except for individuals with a long list of conditions that put them at risk for more severe disease. One of those conditions is pregnancy or recent pregnancy. The COVID vaccine announcements are 'at the least, confusing for patients,' Eckert said. Will Policy Be Challenged? It is not clear whether anyone can or will challenge the HHS policy announcement. Normally, not even a CDC director would circumvent the ACIP's process, said Dorit Reiss, professor of law at UC Law San Francisco. Currently, there is no acting CDC director, she said, adding that it appears that Kennedy has stepped into the role, as he reportedly approved an ACIP recommendation on a chikungunya vaccine. While Kennedy is not violating a statute or regulation with his COVID vaccine announcement, a court could find that the decision is 'arbitrary and capricious' because it was offered without evidence or a rationale, said Reiss. 'These decisions are generally written out with references and a lot of data. They didn't do that,' Reiss told Medscape . Eventually, someone might legally challenge the policy, but it could take a while, said Reiss. The policy 'will have to hurt someone' for someone to make a case, she said. Reiss and Offit pointed out that vaccines could be prescribed off-label for groups that are not covered by any of the HHS recommendations. 'Probably 70% of the drugs on our formulary are not necessarily approved for pediatrics,' said Offit. But off-label use comes with its own set of headaches, he said. Clinicians might have to seek prior authorization from insurers, for instance. When asked whether the administration might just remove approvals altogether for COVID vaccines, Offit responded that with Kennedy in charge, 'anything is possible.' Offit reports no relevant financial relationships. Eckert disclosed that she is the author of 'Enough,' a book that calls for greater cervical cancer screening.
Al Jazeera
2 days ago
- Business
- Al Jazeera
RFK Jr ends COVID vaccine recommendation: What do facts say about risks?
In a one-minute video, US Health and Human Services Secretary Robert F Kennedy Jr revoked the Centers for Disease Control and Prevention's recommendation that healthy children and healthy pregnant women be vaccinated for COVID-19, leaving some experts concerned and others unsure about the policy's details. Kennedy was joined in the video, posted on May 27 on X, by Food and Drug Administration Commissioner Marty Makary and National Institutes of Health Director Jay Bhattacharya. Kennedy, who was tapped by President Donald Trump after a years-long embrace of vaccine conspiracy theories, did not make it clear whether he was referring to a recommendation for children or pregnant women getting vaccinated for the first time, for getting subsequent booster shots, or both. Days after the announcement, HHS's website provided no clarity, saying, 'COVID-19 vaccines are available to everyone 6 months and older. Getting vaccinated is the best way to help protect people from COVID-19.' A Centers for Disease Control and Prevention webpage dated January 7 – before Kennedy was secretary – provided a similar broad vaccine endorsement. Some experts say the low rates of serious COVID-19 cases among children justify tightening the federal vaccine recommendation. Others say that the move will make it harder to get vaccinated and cause preventable serious illnesses. Kennedy broke from norms by not waiting for the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to vote on vaccine guidance at a scheduled June meeting. Recommending against vaccination for certain groups could make it harder for most children and pregnant women to get the shot, if insurers decide not to cover COVID-19 shots for those groups. Immunization rates are already low, with 13 percent of children and 14.4 percent of pregnant women up to date with the 2024-25 edition of the COVID-19 vaccine, the CDC found in late April. We fact-checked the three federal health officials' comments with health experts. Kennedy said, 'Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.' In recent years, the Advisory Committee on Immunization Practices – a group of outside experts that advises the CDC on who should be vaccinated and how often – has recommended annual boosters for healthy children who have already received COVID-19 vaccines. The committee made this recommendation without also recommending that every annual iteration of the vaccine undergo new rounds of clinical trials before being used, said Dr William Schaffner, professor of preventive medicine at the Vanderbilt University Medical Center. (The vaccine had been approved by the FDA for safety and efficacy early in the pandemic.) The panel concluded that the coronavirus vaccine operated in the same way as the annual flu vaccine, which has not required repeated clinical trials, said Schaffner, a former committee member and current adviser. The American Academy of Pediatrics and the American Academy of Family Physicians also recommended COVID-19 vaccinations for children and did not urge new clinical trials. Makary said, 'There's no evidence healthy kids need' the vaccine. This is disputed. Most children will not face serious illness from COVID-19, but a small fraction will. Experts draw different lines when deciding how widespread the vaccination programme needs to be, given this scale of risk. During the 2024-25 COVID-19 season, children and adolescents age 17 and younger comprised about 4 percent of COVID-19-associated hospitalisations. The relatively small number of serious cases among children has driven the belief among some scientists that the universal vaccination recommendation is too broad. However, among all children, rates of COVID-19-associated hospitalisations were highest among infants less than six months old. 'With 4 million new children born every year with no exposure to COVID, young children have rates of disease similar to the disease rates in people older than 65,' Schaffner said, citing a September 2024 article on the CDC's website. COVID-19 was among the top 10 causes of death in children during the worst of the pandemic between 2020 and 2022, said Tara C Smith, a Kent State University epidemiologist. 'Though we may no longer be at that stage … we vaccinate for influenza, so why not continue to do so for COVID?' Some doctors are concerned about the lingering syndrome known as long COVID, about which less is known, especially among children. The outside advisory committees and the medical academies found this level of serious disease to be sufficient to recommend continued annual vaccinations. Makary was accurate when he said that 'most countries have stopped recommending' routine COVID-19 vaccination for children. 'Many countries will only offer the COVID vaccine to children if they have underlying health conditions or are immunocompromised,' said Brooke Nichols, a Boston University associate professor of global health. Makary co-wrote a May 20 article that included a list of booster recommendations in Canada, Europe and Australia. It said in most countries, the recommendation was to vaccinate older people or those at high risk. Most countries have taken this course, Schaffner said, because 'by now, 95 percent of us have had experience with COVID, either through the vaccine or through illness or both. And second, the current variants are thought to be much milder than some of the earlier variants.' The World Health Organization in 2024 recommended the COVID-19 vaccine for children with health risks who had never been vaccinated. For children and adolescents who had previously been vaccinated, it did not routinely recommend revaccination. The European Medicines Agency recommended the BioNtech Pfizer vaccine for children over the age of five years and said the use of the vaccine for children is effective and safe. Euronews reported that the agency issued its recommendation in November 2021 and later recommended the Moderna vaccine for children ages 12 to 17. In the United Kingdom, 'only older people or those with specific diseases or illnesses making them susceptible to severe COVID were recommended to get boosters, and as a result, uptake in those groups was actually higher than in the US,' where outreach and advertising for the vaccinations focused on children as well as older people, said Babak Javid, an associate professor in the division of experimental medicine at the University of California-San Francisco. The New York Times found that in Europe 'many countries do not recommend the vaccines for healthy children under 5, but the shots are approved for everyone 6 months and older,' meaning that they can be safely used by anyone who's at least six months old. Experts disagreed with Kennedy's recommendation against vaccinating pregnant women, saying the vaccine protects pregnant women and their infants. Steven J Fleischman, American College of Obstetricians and Gynecologists president, said, 'It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalised infants less than six months of age – those who are not yet eligible for vaccination – born to unvaccinated mothers.' After a vaccination, antibodies reach the fetus. The doctors' group said there is no evidence the vaccine creates adverse effects for either mother or the fetus, although fever or pain at the injection site are possible. The federal government in May provided conflicting information about the vaccine and pregnancy. In Makary's May 20 article, he and his co-author included pregnancy on the CDC's 2025 list of underlying medical conditions that increase the risk of severe COVID-19. 'They literally contradicted themselves over the course of a couple of days,' said Dr Peter Hotez, Texas Children's Hospital Center for Vaccine Development co-director. 'It appears RFK Jr reversed his own FDA's decision.' Following the May 27 video announcement, Makary told NBC that the decision about vaccination should be between a pregnant woman and her doctor. A 2024 review of 67 studies found that fully vaccinated pregnant women had a 61 percent lower likelihood of a COVID-19 infection during pregnancy. In its June meeting, the Advisory Committee on Immunization Practices might move towards less sweeping recommendations for vaccinating children, closer to those that Kennedy enacted. 'If you listened to the discussions in the most recent previous meeting, they very much seemed to be moving in a more targeted approach,' Schaffner said. The question of pregnant women may be one where the advisory committees may recommend more flexibility with vaccine usage than what Kennedy's video statement seems to suggest, Schaffner said. Other areas where the panels could back greater flexibility could be for otherwise healthy people who serve as caregivers or who live with more vulnerable people who are advanced in age or are immunocompromised.
CNN
3 days ago
- Business
- CNN
How changes to Covid-19 vaccine policy in the US may affect you
The US Department of Health and Human Services, under Secretary Robert F. Kennedy Jr., has recently made significant changes to how Covid-19 vaccines are approved and the groups they are recommended for. For the past few years, the federal government has broadly approved and recommended an updated Covid-19 shot for everyone ages 6 months and up each fall. But last week, leaders from the US Food and Drug Administration outlined a new framework for the approval process for Covid-19 vaccines that could limit shots to older Americans and people at higher risk of serious Covid-19 infection. On Tuesday, Kennedy announced that the vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention's immunization schedule. These changes, made in unconventional ways, will probably affect access to and availability of Covid-19 vaccine shots for millions. Under the framework outlined by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, updated Covid-19 vaccines will probably be approved for everyone 65 and older and for people 6 months and older who have at least one underlying condition that puts them at 'high risk for severe Covid-19 outcomes.' The CDC lists dozens of conditions that may contribute to higher Covid-19 risk, including asthma, cancer, diabetes, obesity and a history of smoking. These underlying conditions will make between 100 million and 200 million people in the US eligible for a Covid-19 vaccine under the new framework, the FDA leaders estimate. Pregnancy is included on the list of factors that the CDC says have shown 'a conclusive increase in risk' for at least one severe Covid-19 outcome. Kennedy did not offer a specific reason behind the decision to stop recommending the Covid-19 for pregnant people in Tuesday's announcement, but the move appears to directly contradict the new framework outlined a week earlier. For kids and adults younger than 65 who do not have an underlying condition, the FDA says it will require in-depth clinical trials before licensing new vaccines. An independent group of advisers to the CDC – the Advisory Committee on Immunization Practices, or ACIP – is expected meet at the end of June to vote on Covid-19 vaccine recommendations, and they had already been weighing options for more targeted risk-based recommendations than the general guidelines issued in previous years. Experts say next month's meeting could be a pivotal moment in the future of Covid-19 vaccine access, with much uncertainty around what will happen if the advisers recommend a different path forward than officials have outlined. Maybe, but it may be more difficult – and expensive. 'Theoretically, one could find someone who would be willing to provide them the vaccine – and they may have to pay out of pocket to get it – but there's a lot of things that have to align for that to happen,' said Dr. Michelle Fiscus, a pediatrician and chief medical officer of the Association of Immunization Managers. Health care providers, including pediatricians, may be able to provide the Covid-19 vaccine 'off-label' – but they'd need to have the vaccine in stock, which has become increasingly uncommon. The vast majority of Covid-19 vaccinations happen at pharmacies. Pharmacists generally don't have the tools to verify medical history and whether an individual has a condition that makes them high-risk, so many of them could take patients at their word. But the recent announcements from the federal government may have a chilling effect on what providers are willing to do, experts say. It's likely that people who are covered by public insurance such as Medicare and Medicaid and who meet the new FDA eligibility requirements will continue to have Covid-19 vaccines covered, experts say. There's more uncertainty around how private insurance companies will choose to adjust coverage. Some of the conditions that the CDC lists as high-risk for Covid-19 – such as 'physical inactivity' – are loosely defined and may be left up to individual plans to interpret. Under the Affordable Care Act, insurance companies are required to cover vaccines for adults if they've been recommended by ACIP. The committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who would not otherwise be able to afford them. However, there's a gray area around what will happen if ACIP recommendations differ from CDC recommendations, experts say. In a video posted on social media on Tuesday, Kennedy said that changes to the recommendations for children and pregnant people took effect that same day. As of Thursday morning, however, the CDC's recommended immunization schedule posted online had not changed. Last week's editorial from Makary and Prasad said that the new framework for vaccine approval would be adopted 'moving forward.' The FDA officials say the new policy balances the need to swiftly approve vaccines – to have them ready by the fall respiratory virus season for the most vulnerable adults and children – against the need for more evidence before offering them to others. Under this newly proposed framework, the FDA says, it will require additional evidence from vaccine manufacturers before approving updated Covid-19 shots for healthy kids and adults. The officials said those studies should last a minimum of six months, which would preclude any findings from influencing approvals in time for this fall. The CDC's independent vaccine advisers meet at the end of June and are expected to vote on this fall's Covid-19 vaccine recommendations. Their decisions have guided vaccine policy in the US for decades, but it's unclear how much influence it will have over the newly announced changes. HHS still hasn't signed off on two of the three recommendations that were made at the group's last meeting, in April. The Covid-19 vaccines that are currently available in the US have been approved by the FDA after rigorous analysis and are considered safe. In their editorial outlining the new framework for Covid-19 vaccine approval, the FDA's Makary and Prasad said that 'the benefit of repeat dosing … is uncertain,' but they did not present evidence that Covid-19 vaccines themselves are unsafe. The agency says it will approve vaccines for healthy kids and adults only after studies that prove that the shots can prevent symptomatic Covid-19 better than a placebo. However, the new plan doesn't take into account other effects of Covid-19 infections, such as long Covid. These changes to Covid-19 vaccine policy limit opportunities to protect people who are at high risk, including young children and pregnant people, experts say 'We have vaccines that we know were critical in saving lives during the pandemic and we continue to see the morbidity and mortality from Covid-19,' Fiscus said. 'It's very concerning that people who would choose to protect themselves or their children with a vaccine may have that choice taken away.' CNN's Brenda Goodman contributed to this report.
Yahoo
3 days ago
- Business
- Yahoo
Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For 'Healthy' Pregnant Women, Children
The U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention's immunization schedule. Kennedy announced the change in a video posted to the social media platform X. 'As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,' Kennedy said. 'Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.' Trending: Maker of the $60,000 foldable home has 3 factory buildings, 600+ houses built, and big plans to solve housing — He was joined by the U.S. Food and Drug Administration Commissioner Dr. Marty Makary and National Institutes of Health Director Dr. Jay Bhattacharya. As of Tuesday morning, the immunization schedule posted online had not yet been changed. In 2021, Kennedy filed a citizen petition requesting the FDA to revoke Emergency Use Authorizations for existing COVID-19 vaccines and refrain from approving and licensing them. The update follows the FDA's changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults. The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad in the New England Journal of Medicine, reported week, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend a monovalent JN.1-lineage vaccine composition. Based on the totality of the evidence, the FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain. On Friday, Moderna Inc. (NASDAQ:MRNA) submitted an application to the FDA to review its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. Also, Novavax Inc. (NASDAQ:NVAX) received limited FDA approval for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a $175 million milestone payment from partner Sanofi SA (NASDAQ:SNY) The approval came after a six-week delay as regulators sought additional data. The vaccine is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the risk of severe COVID-19. Read Next: Hasbro, MGM, and Skechers trust this AI marketing firm — Invest before it's too late. Deloitte's fastest-growing software company partners with Amazon, Walmart & Target – Many are rushing to grab 4,000 of its pre-IPO shares for just $0.30/share! Photo: Shutterstock Send To MSN: Send to MSN UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For 'Healthy' Pregnant Women, Children originally appeared on
