Washington – The Trump administration’s Novavax’s Covid-19 is also sowing uncertainty about updates on updates on the country’s only traditional-based protein-based alternative-based vaccines for the attempt to impose new requirements in the vaccine.
Novavax said on Monday that the food and drug administration agency asked the agency to run a new clinical trial of its vaccine after full approval. The agency says it reacts and believes that its shot remains “approved”.
However, FDA Commissioner Marti Makari suggested the possibility of a new trial before the annual strain update of a weekend post shot on social media – it is unlikely to be possible before falling. It raised the question raised as to whether other vaccines will be caught in turmoil.
“I don’t think it’s a new product that has strain change,” said Dr. Jesse Goodman, head of the former FDA vaccine at the University of Georgitown. If this is the new policy, “You always used to do clinical trials and you could never have a vaccine that was up to date.”
The FDA came to the FDA after being forced to disagree with the agency’s long -time vaccine chief, Health Secretary Robert F. Kennedy Jr.
Kennedy won the Senate confirmation for his work, in some parts, promising not to change the country’s vaccine schedule. Since taking office, he has promised to “investigate” the children’s shots, expert vaccine has canceled the meeting and directed the officers to look back for connecting the vaccine and autism, which is a long-ago link debank.
The Novovax vaccine, which originally showed the effectiveness in the clinical examination of about 30,000, is still being sold under emergency use in the United States for complete FDA approval for a certain age.
As Coronavirus continues to change, manufacturers follow instructions from the FDA to make a change in their recipe every year – which is the only pressure to notice the flu vaccine.
According to the two of the direct knowledge of the situation that he spoke on the condition of anonymity to discuss the issues related to the confidential agency, the FDA was on the verge of fully approval by its April 1 April target date. However, Trump employers instructed FDA scientists to break their decisions, according to one. Since this is a very unusual step, the additional requirements for the approval of Novovax and agency.
In his weekend tweets, the FDA’s McCerry Novovax referred to the vaccine as “a new product”, perhaps it was updated last year to match the general coronavirus strain.
“New clinical studies are required for new products,” added to the maker.
A spokesperson of the administration did not answer specific questions about Fizzer and Modern but suggested that all Covid -10 vaccines could face strict requirements.
Health and Human Services spokesman Andrew Nixon said in a statement, “Covid once presented the threats and the urgently was no longer present in the approval of boasters without general supervision.”
Dr. Paul Offet, a vaccine expert at Philadelphia’s Children’s Children’s Hospital, said that the FDA flu vaccines have been done for decades, but only the existing topics that are adjusted against the latest strains have been treated as the annual Covid -19 strain updates.
“The companies still have to test the small number of people that these updated vaccines produce the level of virus-fighting antibodies known as protective and they are closely monitored to protect the protection.”
Nixon, a HHS spokesman, suggests that the policy may not apply to the flu shot, “which has been tried and tested for more than 3 years.”
Under the Federal Act, FDA approval should follow the established procedures when issuing the requirements of the pharmaceuticals. Experts say that if the agency avoids specific steps or imposes additional requirements for political reasons or imposes additional requirements, it can be sued by drug makers – or even patients, such as those who prefer novovax vaccine compared to allergies or any other contestants.
Former Health Secretary Javier Berrera, who monitors the Covid -1 vaccine policy during the Biden Administration, said that in addition to large clinical trials conducted for the use of three covid -1 vaccines, there are information about real -world use.
“We left nearly 700 million Covid vaccine in Americans weapons,” he said. “It’s pretty good -size clinical trial” “”
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AP Author Amanda Sitz contributed to this story
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Associated Press Health and Science Department has received the support of the Science and Educational Media Group and Robert Wood Johnson Foundation of the Hughes Medical Institute. AP is the sole responsible for all content.
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