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.”
