Washington – The Trump administration effort to impose New requirements in NOVAVAX COVID-19 vaccine – The only one in the nation Traditional Protein Based Option For the Coronavirus, it is also sowing uncertainty about the updates of other vaccines.
Novavax said Monday that the Food and Medicines Administration was asking the company to execute a new clinical trial of its vaccine After the agency grants full approval. The company said he had responded and believed that his shot is still “approval.”
But a weekend mail In social networks by FDA Commissioner Marty Makary He suggested the possibility of needing a new test before the update of the annual tension of the shots, something unlikely possible before autumn. That has asked questions about whether Other vaccines It will be caught in agitation.
“I don’t think that there is a voltage change that this is a new product,” said Dr. Jesse Goodman from the University of Georgetown, a former FDA Vaccine Chief. If that is the new policy, “I would always be doing clinical trials and would never have a vaccine that was updated.”
The unusual movement in the FDA occurs shortly after the agency Head of vaccine for a long time He was expelled About disagreements With the chief of Makary, Secretary of Health Robert F. Kennedy Jr.
Kennedy won the Senate confirmation to his work, in part, by promising not to change the nation’s vaccine schedule. Since he assumed office, he is promised to “investigate” the shots of the childrenCanceled Meetings Expert vaccine advisors And they ordered officials to seek connections between vaccines and autism again, a link A long time ago discredited.
The Novavax vaccine, which originally showed effectiveness in a clinical trial of almost 30,000 people, is still sold under the authorization of emergency use in the United States, the other two RNM options, the HRNM vaccines made by Pfizer and Modern, have obtained the complete approval of the FDA for certain age groups.
Because the coronavirus continually mutates, The manufacturers follow the instructions From the FDA to make a change every year to its recipe, which is tense to aim, as well as the flu vaccines.
The FDA was on its way to granting Novavax’s total approval for its objective date of April 1, according to two people with direct knowledge of the situation that spoke on condition of anonymity to discuss issues of confidential agencies. But Trump’s appointed ordered FDA scientists to pause their decision, according to one of the people. Since that highly unusual movement, Novavax and the agency have been discussing additional requirements for approval.
In his weekend tweet, Makary de la FDA referred to the Novavax vaccine as “a new product”, presumably because it had been updated to coincide with the common coronavirus strain last year.
“New products require new clinical studies,” Makary added.
A administration spokesman did not answer specific questions about Pfizer and Modern, but suggested that all COVID-19 vaccines could face stricter requirements.
“Years have spent since Covid has presented the threat he ever did, and the urgency of hurrying the approval of reinforcements without normal supervision no longer exists,” said Andrew Nixon, a spokesman for health and human services, in a statement.
The FDA had been dealing with the annual updates of COVID-19 strains exactly how it has been done for decades with flu vaccines, not as new products, but existing that simply adjust to protect against the latest strains, said Dr. Paul Offit, an expert in vaccine hospital in the Children’s Hospital in Philadelphia.
Offit said that companies must still test in small numbers of people who show that these updated vaccines produce antibody levels to combat viruses that are known to be protectors, and are closely monitored by safety.
Nixon, the HHS spokesman, suggested that the policy may not be applied to the flu vaccine, “which has been tried and tested for more than 80 years.”
According to the Federal Law, the FDA must follow established procedures when issuing requirements to medication manufacturers for approval. If the agency jumps certain steps or imposes additional requirements for political reasons, experts say, medication manufacturers could be sued, or even patients, such as those who prefer Novavax vaccine about their competitors due to an allergy or some other reason.
In addition to the great clinical trials carried out before the three COVID-19 vaccines were for use, there is data on the use of real world, said former Secretary of Health Xavier Becerra, who supervised the Vaccine Policy COVID-19 COVID-19 during the Biden administration.
“At the point where I had gone, we had put about 700 million Covid vaccines in the arms of the Americans,” he said. “That is a good size clinical trial.”
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The AP writer Amanda Seitz contributed to this story
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