Latest news with #PfizerBioNTech
Yahoo
18-05-2025
- Health
- Yahoo
RFK Jr's FDA limits use of Covid vaccine
The Food and Drug Administration, now under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., has severely restricted the use of the NovavaxCOVID-19 vaccine. The vaccine will now only be available to high-risk individuals and will not be administered to those who may need it to protect others. Kennedy's FDA approved the use of the Novavax Covid-19 vaccine, but with strict conditions. It will only be made available to older people and those over the age of 12 with at least one medical condition that leaves them at high risk from Covid, The New York Times reported. Centers for Disease Control and Prevention advisers have been discussing whether to recommend the vaccine only for those most at risk. The new restrictions mean that healthy people over the age of 65 won't be able to get the Novavax vaccine, even if they have an immunocompromised friend or family member. Critics have slammed the restrictions for being in line with Kennedy's vaccine skepticism. The secretary has ordered an investigation into the debunked claim that vaccines cause autism. The Novavax vaccine was previously only allowed to be used in emergencies. Meanwhile, the FDA gave full approval to vaccines by Pfizer-BioNTech and Moderna in 2022 under the Biden administration. Both companies are producing updated versions of their vaccines for the fall. Former CDC adviser and Massachusetts General Hospital infectious disease physician Dr Camille Kotton told The Times that the new restrictions were 'incredibly disappointing.' 'I don't know why they would make this restriction; I don't know of any indication to make this change,' she added. She noted that many people are still sent to hospital and dying because of Covid-19. She called it 'a dark day in American medicine.' The vaccine's approval requires the company to finish studies into whether it is connected to several heart conditions. However, some of the necessary research can be done with existing data. However, The Times reported that one of the new studies would force the company to follow thousands of people between the ages of 50 and 65, a study that may cost tens of millions of dollars. Dr. Ofer Levy of Boston Children's Hospital, where he directs the precision vaccine program, is a vaccine adviser to the FDA. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' Levy noted. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' 'I don't pretend to know the answer,' Levy added. Dr. Paul Offit is a vaccine expert at the Children's Hospital of Philadelphia. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive, and more feared,' he told the paper. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.'
The Independent
18-05-2025
- Health
- The Independent
RFK Jr's FDA limits use of Covid vaccine
The Food and Drug Administration, now under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., has severely restricted the use of the Novavax COVID-19 vaccine. The vaccine will now only be available to high-risk individuals and will not be administered to those who may need it to protect others. Kennedy's FDA approved the use of the Novavax Covid-19 vaccine, but with strict conditions. It will only be made available to older people and those over the age of 12 with at least one medical condition that leaves them at high risk from Covid, The New York Times reported. Centers for Disease Control and Prevention advisers have been discussing whether to recommend the vaccine only for those most at risk. The new restrictions mean that healthy people over the age of 65 won't be able to get the Novavax vaccine, even if they have an immunocompromised friend or family member. Critics have slammed the restrictions for being in line with Kennedy's vaccine skepticism. The secretary has ordered an investigation into the debunked claim that vaccines cause autism. The Novavax vaccine was previously only allowed to be used in emergencies. Meanwhile, the FDA gave full approval to vaccines by Pfizer-BioNTech and Moderna in 2022 under the Biden administration. Both companies are producing updated versions of their vaccines for the fall. Former CDC adviser and Massachusetts General Hospital infectious disease physician Dr Camille Kotton told The Times that the new restrictions were 'incredibly disappointing.' 'I don't know why they would make this restriction; I don't know of any indication to make this change,' she added. She noted that many people are still sent to hospital and dying because of Covid-19. She called it 'a dark day in American medicine.' The vaccine's approval requires the company to finish studies into whether it is connected to several heart conditions. However, some of the necessary research can be done with existing data. However, The Times reported that one of the new studies would force the company to follow thousands of people between the ages of 50 and 65, a study that may cost tens of millions of dollars. Dr. Ofer Levy of Boston Children's Hospital, where he directs the precision vaccine program, is a vaccine adviser to the FDA. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' Levy noted. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' 'I don't pretend to know the answer,' Levy added. Dr. Paul Offit is a vaccine expert at the Children's Hospital of Philadelphia. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive, and more feared,' he told the paper. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.'
New York Times
17-05-2025
- Health
- New York Times
F.D.A. Approves Novavax Covid Vaccine With Stricter New Conditions
The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid. Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The F.D.A.'s decision appeared to render at least part of their discussion moot. The new restriction will limit access to the Novavax vaccine for people under 65 who are in good health. It may leave Americans who do not have underlying conditions at risk if a more virulent version of the coronavirus were to emerge. It could also limit options for people who want the vaccine for a wide array of reasons, including to protect a vulnerable loved one. The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A. The F.D.A.'s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies. 'This is incredibly disappointing,' said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital who cares for immunocompromised patients, and a former adviser to the C.D.C. 'I don't know why they would make this restriction; I don't know of any indication to make this change,' Dr. Kotton said, adding that many people are still hospitalized and dying as a result of Covid. 'This is a dark day in American medicine.' The approval of the shot, called Nuvaxovid, requires the company to complete studies on whether the vaccine is associated with several heart conditions. Some of the required research is possible to complete with available data. But one new study would most likely require the company to follow thousands of healthy people who are 50 to 65 years old who take either the vaccine or a placebo. That study could cost tens of millions of dollars, at least, according to people familiar with such work. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' said Dr. Ofer Levy, director of the precision vaccine program at Boston Children's Hospital and an adviser to the F.D.A. on vaccines. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' Dr. Levy said. 'I don't pretend to know the answer.' The F.D.A. said that a study of the Novavax shot in people younger than 12 is C. Jacobs, the Novavax chief executive, said the approval was a 'significant milestone' solidifying a pathway for the people who are most likely to seek out Covid vaccination to get the company's shot. The new restrictions on the shot could create a raft of problems for those who want the vaccine. For one, the approval document is unclear about what qualifies as an underlying condition. Prescribing the shots in healthy people under 65 would be considered off-label use, making it less likely that insurers would broadly cover the shots. 'I think we're left confused about what this means for the consumer,' said Dr. Paul Offit, a vaccine expert from Children's Hospital of Philadelphia and an adviser to the F.D.A. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive and more feared,' Dr. Offit said. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.' Approval of the Novavax Covid shot also bucks norms that have been in place since the vaccines were first approved. This is the first time that the F.D.A. has included health criteria for Covid shots. Those decisions are typically made by the C.D.C.'s advisers. Insurance carriers are required to cover vaccines recommended by the advisers, but the panel usually cannot expand the vaccine's use beyond the bounds of the F.D.A. approval. Novavax's Covid shot was the last to become available during the pandemic because of unexpected manufacturing problems. It has been offered under emergency authorization since July 2022. On Thursday, Dr. Marty Makary, who leads the F.D.A., said the agency would soon release a new framework for evaluating Covid shots. A meeting is scheduled for this coming Thursday to select the version of the virus that the fall Covid shots will cover. Nuvaxovid is based on a more traditional vaccine platform, and is generally thought to have fewer side effects. It has served as an attractive alternative for those who are wary of the newer technology used in the mRNA vaccines made by Pfizer-BioNTech and Moderna. 'I have been recommending this vaccine for everyone who is mRNA-vaccine reluctant,' Dr. Kotton said. She said she and her two sons all opted for Novavax last fall, but none of them would qualify under the new criteria.
