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Trump managementMake an effort to applyNew RequirementsNovavax’s Covid-19 vaccine– the only one of the nationTraditional protein-based choiceFor Coronavirus – planting uncertainty about updates in other vaccines.
Novavax said that food and drug administration asks the company to hold a new clinical test on MondayvaccinationAfter the agency has been fully approved. The company said he responded and believed that his shot was “confirmation.”
But a weekendpostby social mediaFDA Commissioner Marty MakaryThe shooting suggested that it is needed in the hope of being a new judgment before the annual strain – it is impossible to be possible before falling. The questions about this were raisedOther vaccineswill be caught in confusion.
“I don’t think this is a new product,” said, “said Jesse Goodman, the head of the former Fda vaccine Jesse Goodman. If this is a new policy,” You will always have clinical trials and never be a vaccine. “
The unusual action in FDA comes after a period of agency Vaccination Chief for a long time it was Ried over the disputes Secretary of Health with Makary’s boss Robert F. Kennedy Jr.
Kennedy promises not to change the citizen’s vaccine schedule, and partially won the senate approval. Since the Office was carried, hePromised to “examine” children’s shootingcanceledExpert vaccine consultantsand a link in officials to re-look for the relationship between vaccines and autismDebunked for a long time ago.
Novaavax vaccine, which is initially effective in a clinical test for about 30,000 people, is still vaccinated by two other versions of the United States, MRNA Pfizer and ModernI won the full FDA approval for certain age groups.
Because Coronavirus is constantly mutating,Manufacturers follow the instructionsTo convert a change to the prescription of the FDA every year – to target the target – just like flu vaccinations.
The FDA was on the road to ensure the full consent of Novavax, April 1, and according to two people, direct knowledge of the situation with the situation to discuss confidential agency issues. However, Trump appointments, FDA scientists focused on suspending their decisions for one of the people. Due to this highly unusual action, Novavax and agency discussing additional requirements for approval.
In the weekend tweet, FDA’s Makary was commemorated as a “new product” as a vaccine, “a new product”, because it was updated for the last year’s Coronavirus tension.
“New products require new clinical research,” he said.
An administration did not answer specific questions about Pfizer and modernity, but all Coven-19 vaccines suggested that they could face harsh requirements.
“Now the Covid has not already available for the confirmation of strengthen without providing a danger that once and without normal control,” he said.
FDA, annual Covid-19 voltage updates for decades are not like flu vaccines, not just the latest strains, the most regulated existing ones, Dr. Paul Philadelphia is a vaccine expert.
The Sdib still needs to test companies that show that companies still show the level of virus-combat antibodies, which are known to be a protective of these updated vaccines and are closely monitoring for security.
HHS spokesman Nikson does not apply to the influenza of politics, “tested and tested for more than 80 years.”
As part of the Federal Law, the FDA requires the procedures set out when demanding the requirement to drug manufacturers. If the agency takes certain steps or applies additional requirements for political reasons, specialists, drugs or even patients can be sued by Novavax vaccine via Novavax vaccine for an allergy or another reason.
In addition to the use of all three Covenant-19 vaccine, there is information on the use of the real world, in addition to untreated large clinical trials.
“At the point where I went, we have vaccinated 700 million coves in the arms of Americans,” he said. “This is a pretty good sized clinical test.”
This story was first displayed Fortune.com
