The Food and Drug Administration approved the Novavax Covid-19 vaccine on Friday, but only for older adults and for others older than 12 years who have at least one medical condition that brings them with a high risk of COVID.
Scientific advisers of the Centers for Disease Control and Prevention, who usually make decisions about who should get approved shots and when, when, debated Whether you should only recommend COVID recordings to the most vulnerable Americans. The FDA’s decision seemed to make at least part of their discussion.
The new limitation reduces access to the Novavax vaccine for people younger than 65 who are in good health. It can be Americans who do not have underlying disorders that are not at risk if a more virulent version of the coronavirus arose. It can also limit options for people who want the vaccine to protect a wide range of reasons, including to protect a vulnerable loved one.
The vaccine was previously authorized under emergency. COVID vaccines developed by Pfizer-Biontech and Moderna, which are widely used by Americans, granted full approval in 2022. However, the companies are working on updated shots for autumn, and the new restrictions on the Novavax Shot Portend A restrictive approach to the FDA
The new limitations of the FDA also seemed to reflect the high degree of skepticism about vaccines by Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health authorities.
“This is incredibly disappointing,” said Dr. Camille Kotton, a doctor in infectious diseases in the Massachusetts General Hospital who takes care of patients with immunocomromized and a former CDC adviser
“I don’t know why they would make this limitation; I don’t know any indication to make this change,” said Dr. Kotton, adding that many people are still admitted to the hospital and die as a result of Covid. “This is a dark day in American medicine.”
The approval From the shot, called Nuvaxovid, requires the company to complete studies or the vaccine is associated with different heart conditions. Part of the required examination is possible to complete the available data.
But a new study would most likely require the company to follow thousands of healthy people who are 50 to 65 years old who take the vaccine or a placebo. That study can cost at least tens of millions of dollars according to people who are familiar with such a work.
“We must ensure that vaccine safety is crystal clear to cause the trust of the public,” said Dr. Orer Levy, director of the Precision Vaccine Program in Boston Children’s Hospital and a FDA adviser on vaccines.
“On the other hand, where is the line where you are in too many regulations, it is starting to become so challenging that the economy of even making a vaccine is questioned?” Dr. Levy said. “I don’t pretend I know the answer.”
The FDA said that a study of the Novavax recording in people younger than 12 is going on.
John C. Jacobs, the Novavax Chief Executive, said that the approval was an “important milestone” that stimulated a path for the people who most likely look for Covid vaccination to get the shot from the company.
The new limitations on the shot can cause a series of problems for those who want the vaccine. Firstly, the approval document is unclear about what is eligible as an underlying condition. Prescribing the recordings in healthy people younger than 65 would be considered off-label use, making it less likely that insurers would cover the shots in broad lines.
“I think we are confused about what this means for the consumer,” said Dr. Paul Offit, a vaccine expert from the Philadelphia Children’s Hospital and an adviser to the FDA
“I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive and more feared,” said Dr. Offit. “His goal is to tear away the vaccine infrastructure, because he believes that vaccines are not favorable and are only harmful.”
Approval of the Novavax Covid -Schot Bokt also that has been approved for the first time since the vaccines. This is the first time that the FDA has recorded health criteria for COVID shots. Those decisions are usually made by the CDC advisers.
Insurance companies are obliged to cover vaccines that are recommended by the advisers, but the panel cannot usually expand the use of the vaccine outside the boundaries of the FDA property inspection.
Novavax’s shot was the last to become available during the pandemic due to unexpected production problems. It has been offered under emergency authorization Since July 2022.
On Thursday Dr. Marty Makary, who leads the FDA, that the agency would soon release a new framework for evaluating Covid shots. A meeting is planned for the coming Thursday to select the version of the virus that will cover the Fall Covid recordings.
Nuvaxovid is based on a more traditional vaccine platform and is generally supposed to have fewer side effects. It served as an attractive alternative to those who are wary of the newer technology used in the MRNA vaccines made by Pfizer-Biontech and Moderna.
“I have recommended this vaccine for anyone who is reluctant MRNA vaccine,” said Dr. Kotton. She said that she and her two sons chose Novavax last fall, but none of them would qualify under the new criteria.
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