Latest news with #JesseGoodman
Japan Times
a day ago
- Health
- Japan Times
Kennedy dismisses all 17 members of U.S. CDC vaccine panel
U.S. Health Secretary Robert F. Kennedy Jr. has fired all members sitting on a U.S. Centers for Disease Control and Prevention panel of vaccine experts and is reconstituting the committee, his department said on Monday. Kennedy removed all 17 members of the Advisory Committee on Immunization Practices (ACIP), the Department of Health and Human Services (HHS) said in a statement, and is in the process of considering new members to replace them. The ACIP panel is tasked with recommending which vaccines get placed on the CDC immunization schedule and who should get them, which helps determine insurance coverage. "Today we are prioritizing the restoration of public trust above any specific pro- or anti-vaccine agenda," Kennedy said. "The public must know that unbiased science — evaluated through a transparent process and insulated from conflicts of interest — guides the recommendations of our health agencies." All 17 sitting ACIP members were appointed under former President Joe Biden's administration, including 13 in 2024, HHS said. Not removing them would have prevented President Donald Trump's administration from choosing a majority of the committee until 2028. "That's a tragedy," former Food and Drug Administration Chief Scientist Jesse Goodman said of the firings. "This is a highly professional group of scientists and physicians and others ... It's the kind of political meddling that will reduce confidence rather than increase confidence." Kennedy, who for many years has questioned the safety and efficacy of vaccines, making claims contrary to scientific evidence, said the change was necessary because the committee is rife with conflicts of interest and most members receive funding from drugmakers. But ACIP members are required to declare any potential or perceived conflicts of interest that arise in the course of ACIP tenure and any relevant business interests, positions of authority or other connections with organizations relevant to the work of the ACIP. "Our worst fears have been realized," said one expert with close ties to the committee, adding that the vetting of ACIP members "is very, very rigorous." Kennedy and HHS provided no specific evidence of industry conflicts of interest among departing ACIP members. The CDC's web page for conflicts of interest, last updated in March, showed that one current member had recused herself from votes on a handful of vaccines because she had worked on clinical trials for their manufacturers. ACIP will convene its next meeting over June 25-27 at CDC headquarters in Atlanta, the department said. The change was first announced in an editorial written by Kennedy for the Wall Street Journal. At least one ACIP member who spoke on the condition of anonymity learned that they were being retired from the committee from the editorial and they believe none of the members had been notified by the CDC. ACIP members were required to disclose everything as part of the application process, including investments and all sources of income, the member said. Once the FDA approves vaccines for sale to the public, the ACIP role is to review data in a public meeting and vote on vaccine recommendations, which are then sent to the CDC director to sign off. The Affordable Care Act generally requires insurers to cover vaccines that are listed on the CDC vaccine schedule.
Al Jazeera
a day ago
- Health
- Al Jazeera
Robert Kennedy Jr expels all 17 members of CDC vaccine panel
United States Health and Human Services (HHS) Secretary Robert Kennedy Jr has purged a 17-member panel at the Centers for Disease Control and Prevention (CDC) that provides expertise on vaccines. Kennedy, who before taking a position in the administration of President Donald Trump was a vocal anti-vaccine activist, has said he will replace the panel with his own picks. 'Today, we are prioritising the restoration of public trust above any specific pro- or anti-vaccine agenda,' Kennedy said. 'The public must know that unbiased science – evaluated through a transparent process and insulated from conflicts of interest – guides the recommendations of our health agencies.' Kennedy's reorganisation of the CDC's Advisory Committee on Immunization Practices (ACIP) is the latest move by the Trump administration to shake up US health practices, sometimes by pushing ideas that depart strongly from the existing scientific consensus on issues such as vaccinations and fluoride. 'That's a tragedy,' a former chief scientist of the Food and Drug Administration (FDA), Jesse Goodman, said of the firings. 'This is a highly professional group of scientists and physicians and others … It's the kind of political meddling that will reduce confidence rather than increase confidence.' The HHS said that all 17 members of the panel were selected during the administration of former President Joe Biden, and that keeping them on would have prevented Trump from choosing the majority of the panel's members until 2028. The department said that the ACIP will convene its next meeting on June 25-27. While the Food and Drug Administration (FDA) approves vaccinations for public use, the ACIP reviews data in public meetings before voting on whether to recommend a vaccine.
Yahoo
23-05-2025
- Health
- Yahoo
FDA picks a new strain for fall Covid vaccines. Here's what it means for your next shot.
The Food and Drug Administration said late Thursday it would like drugmakers to update the Covid vaccines to target the LP.8.1 strain, fueling concerns that the shots may be limited to only the most at-risk Americans this fall. The FDA's decision differs slightly from the recommendation made by its vaccine advisory committee earlier that day, which was to stick to the strains used in the current Covid shots, although panel members said LP.8.1 was a suitable alternative. Studies by Moderna and Pfizer showed that an LP.8.1-targeted vaccine in fact induced a modestly stronger immune response to the circulating strains than the current Covid shots, which target a variant called JN.1 or one of its descendants, KP.2. LP.8.1 is also a descendent of JN.1, and it is the dominant strain circulating in the U.S., accounting for roughly 3 in 4 new Covid cases, according to FDA briefing documents released earlier this week. It's different from a strain dubbed NB.1.8.1 that was recently detected in the U.S. and caused a surge in hospitalizations in China. Normally, changing the strain for the vaccine wouldn't raise questions — it's been the practice of the U.S. in recent years, following a similar model to how the flu shot is updated each year. For Pfizer and Moderna, their mRNA technology makes it particularly easy to update their vaccines. But this year, the change is expected to trigger new rules by the FDA that new Covid vaccines for healthy kids and adults must undergo placebo-controlled clinical trials — a process Dr. Marty Makary, the agency's commissioner, told a Senate committee on Thursday could take roughly a year. The updated Covid shots are still expected to be available in the fall to adults 65 and up and kids and adults with at least one medical condition that puts them at risk for severe illness — two groups that are exempt from the clinical trial requirement. The list of underlying conditions that raises a person's risk is extensive — 'physical inactivity' is even included. Officials estimated that more than 100 million people in the U.S. would still qualify for a shot. But the clinical trial requirement 'would clearly delay and impede access to vaccines for those people who want it,' said Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA. However, Goodman added, a number of questions remain about the FDA's policy, including how many people would be needed for the trials and whether a new strain selection would indeed trigger the new trial requirement. When asked by committee members about the new policy on Thursday, FDA officials either said that the questions were off-topic or that the agency was still finalizing the details with drugmakers. The FDA's notice also states it would 'preferentially' like drugmakers to update their shots to the LP.8.1 strain — potentially leaving room for drugmakers to stick to their existing formulations. 'I suspect we will learn more and their approach may become clearer and/or evolve in coming days,' Goodman said. He added it makes sense to leave room for drugmakers to update to either strain, noting it's often difficult to predict how Covid will evolve. The FDA directed all media inquiries to the Department of Health and Human Services. 'The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus,' Emily Hilliard, a spokesperson for HHS, wrote in an emailed statement. 'A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden Administration is now over.' In a statement, a Pfizer spokesperson directed NBC News to comments by the company Thursday, which stated it was prepared to 'initiate supply of a 2025/2026 vaccine formula per FDA guidance, immediately upon approval.' Moderna and Novavax did not immediately respond to requests for comment. There are also questions about insurance coverage and whether patients who are ineligible for the shots would have to pay out of pocket if they wanted one. Pfizer and Moderna are charging up to $150 per dose for a Covid vaccine, according to the CDC's vaccine price list. The agency doesn't list the cost of the Novavax vaccine, which was fully approved earlier this month. In a statement, a spokesperson for America's Health Insurance Plans, an industry trade group, said, 'Health plans have prioritized providing affordable access to preventive services, including vaccines.' 'We will continue to monitor the forthcoming recommendations and guidance from ACIP and CDC,' the spokesperson said, referring to the CDC's vaccine advisory committee. 'As of today, there is no change in how plans cover the existing vaccines for the previously recommended populations.' This article was originally published on
NBC News
23-05-2025
- Health
- NBC News
FDA picks a new strain for fall Covid vaccines. Here's what it means for your next shot.
The Food and Drug Administration said late Thursday it would like drugmakers to update the Covid vaccines to target the LP.8.1 strain, fueling concerns that the shots may be limited to only the most at-risk Americans this fall. The FDA's decision differs slightly from the recommendation made by its vaccine advisory committee earlier that day, which was to stick to the strains used in the current Covid shots, although panel members said LP.8.1 was a suitable alternative. Studies by Moderna and Pfizer showed that an LP.8.1-targeted vaccine in fact induced a modestly stronger immune response to the circulating strains than the current Covid shots, which target a variant called JN.1 or one of its descendants, KP.2. LP.8.1 is also a descendent of JN.1, and it is the dominant strain circulating in the U.S., accounting for roughly 3 in 4 new Covid cases, according to FDA briefing documents released earlier this week. It's different from a strain dubbed NB.1.8.1 that was recently detected in the U.S. and caused a surge in hospitalizations in China. Normally, changing the strain for the vaccine wouldn't raise questions — it's been the practice of the U.S. in recent years, following a similar model to how the flu shot is updated each year. For Pfizer and Moderna, their mRNA technology makes it particularly easy to update their vaccines. But this year, the change is expected to trigger new rules by the FDA that new Covid vaccines for healthy kids and adults must undergo placebo-controlled clinical trials — a process Dr. Marty Makary, the agency's commissioner, told a Senate committee on Thursday could take roughly a year. The updated Covid shots are still expected to be available in the fall to adults 65 and up and kids and adults with at least one medical condition that puts them at risk for severe illness — two groups that are exempt from the clinical trial requirement. The list of underlying conditions that raises a person's risk is extensive — 'physical inactivity' is even included. Officials estimated that more than 100 million people in the U.S. would still qualify for a shot. But the clinical trial requirement 'would clearly delay and impede access to vaccines for those people who want it,' said Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA. However, Goodman added, a number of questions remain about the FDA's policy, including how many people would be needed for the trials and whether a new strain selection would indeed trigger the new trial requirement. When asked by committee members about the new policy on Thursday, FDA officials either said that the questions were off-topic or that the agency was still finalizing the details with drugmakers. The FDA's notice also states it would 'preferentially' like drugmakers to update their shots to the LP.8.1 strain — potentially leaving room for drugmakers to stick to their existing formulations. 'I suspect we will learn more and their approach may become clearer and/or evolve in coming days,' Goodman said. He added it makes sense to leave room for drugmakers to update to either strain, noting it's often difficult to predict how Covid will evolve. The FDA directed all media inquiries to the Department of Health and Human Services. 'The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus,' Emily Hilliard, a spokesperson for HHS, wrote in an emailed statement. 'A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden Administration is now over.' In a statement, a Pfizer spokesperson directed NBC News to comments by the company Thursday, which stated it was prepared to 'initiate supply of a 2025/2026 vaccine formula per FDA guidance, immediately upon approval.' Moderna and Novavax did not immediately respond to requests for comment. There are also questions about insurance coverage and whether patients who are ineligible for the shots would have to pay out of pocket if they wanted one. Pfizer and Moderna are charging up to $150 per dose for a Covid vaccine, according to the CDC's vaccine price list. The agency doesn't list the cost of the Novavax vaccine, which was fully approved earlier this month. In a statement, a spokesperson for America's Health Insurance Plans, an industry trade group, said, 'Health plans have prioritized providing affordable access to preventive services, including vaccines.' 'We will continue to monitor the forthcoming recommendations and guidance from ACIP and CDC,' the spokesperson said, referring to the CDC's vaccine advisory committee. 'As of today, there is no change in how plans cover the existing vaccines for the previously recommended populations.'
Yahoo
07-05-2025
- Health
- Yahoo
Moderna's combo Covid and flu mRNA shot outperforms current vaccines in large trial
Moderna's combined Covid and flu shot outperformed the existing standalone vaccines for both viruses, according to the results of a phase 3 clinical trial published Wednesday in the Journal of the American Medical Association. The vaccine uses the same messenger RNA technology as Moderna's approved Covid vaccine. (There are no approved mRNA-based flu shots.) The trial, funded by Moderna, included more than 8,000 adults ages 50 and older who were enrolled in October and November 2023. For people ages 50 to 64, the new vaccine was compared to Moderna's Covid vaccine and the flu shot Fluarix. For people 65 and older, it was compared to the Covid vaccine and a different flu shot, called Fluzone, which is a stronger dose typically given to older adults. The trial participants either got the existing shots, or the new combination vaccine plus a placebo shot. (This way, both groups got two injections.) The main goal of the trial was to see whether the combination vaccine generated more antibodies in blood samples than the current shots against multiple strains of influenza and the XBB.1.5 Covid variant. This so-called serological testing is a common way for researchers to gauge how well a vaccine shot might work and how long the protection might last. The trial found that antibody levels were higher for Covid and all but one influenza strain in people who got the combination vaccine, compared to those who got the existing shots in both groups. Dr. Buddy Creech, a pediatric infectious disease physician at Vanderbilt University Medical Center in Nashville, Tennessee, said the antibody levels generated by the new vaccine were about 20% to 40% higher. Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and former chief scientist at the Food and Drug Administration, said the trial results are a good sign that the combination shot will provide protection against both Covid and the flu. 'We know that antibody responses generally correlates with a degree of protection,' Goodman said. 'This is very promising and it suggests this vaccine should have similar or higher levels of protection to traditional flu vaccines.' Side effects such as fever and chills were more common in people who got the new vaccine. Creech attributed that to how the body is responding to the vaccine. 'Immunologically, what's happening in each cell is they're acting as if they've been infected with both viruses, and so your immune system is going to respond and make the type of inflammation that you would if you had flu or Covid or both simultaneously,' he said. A combination shot would make it easier for people to get vaccinated against both Covid and the flu, especially since both shots usually come out in the fall. A new shot that provides better protection is needed, experts say, because the existing vaccines don't do a good job at stopping infections. The data is expected to be used to support Moderna's application to the FDA for approval. Last week, Moderna said it doesn't expect regulatory approval for its combination shot until 2026, after the agency said it required late-stage data showing the shot's efficacy against the flu. It's unclear whether the agency's new rule that all new vaccines will need to undergo placebo-controlled clinical trials to gain approval will apply to the combination shot. The FDA already delayed Novavax's Covid vaccine, requiring an additional clinical trial, and may impose the requirement for Pfizer's and Moderna's updated Covid vaccines for the fall. A Moderna spokesperson declined to comment. An HHS spokesperson did not immediately respond to a request for comment. Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children's Hospital Center for Vaccine Development, noted that mRNA vaccines are a particular target among anti-vaccine activists, and several states have introduced legislation that would ban them. 'One of the things I'm concerned about, at least for the United States, is all the anti-vaccine sentiment, and this specific targeting of the mRNA vaccine platform by anti-vaccine activists,' he said. Hotez said Moderna's combination shot would be 'a potentially very useful advance,' as it would only require people to take one shot for two respiratory virsuses. 'If this works, you could also use it for adding RSV or as well as other pathogens,' he said. Goodman, of Georgetown University, said an mRNA-based shot that also targets the flu could help the U.S. respond more quickly if there were a pandemic caused by influenza. The current flu shots primarily rely on growing strains the of the virus in eggs, which is slower to make compared to the mRNA vaccines. This article was originally published on
