The U.S. Organizational Agency for US drugs has failed to grant Total approval of the Novavax vaccine Against it Covid-19The company stated on Wednesday, in the midst of important changes in health agencies under President Donald Trump’s state.
In a document sent to the financial market organizer and witnessed by Agence France -Presse, the American drug manufacturer Novavax said he was still awaiting a response from the Food and Drug Administration (FDA), which was promised to take a decision before April 1.
“Until Tuesday, April 1, we responded to all the requests of the Food and Drug Administration information,” Novavax said at the presentation.
“As of today, we are still waiting for the agency’s response and we have not yet received an official decision in the FDA,” he added.
The company seeks to obtain full approval for its vaccine against Covid-19, which is already designed in the United States by making emergency use of More than 12 years old.
The delay occurs in the middle of an important restructuring of the health agencies, headed by Minister of Health Trump, Robert F. Kennedy Junior, a great skeptical of vaccines.
Why don’t you agree to the vaccine?
The approval of the Covid-19 vaccine can face delays due to various factors, including changes in management agencies management, additional data requests and potential concerns Side effects.
A similar case to Novevax is the case of a modern vaccine for teenagers from 12 to 17 years. In 2021, the Food and Drug Administration (FDA) made its decision regarding this vaccine to assess the risk of myocarditis, an inflammation of the heart, and it is rarely observed in this age group.
This additional analysis has postponed possible approval until January 2022.
Each special case, and therefore the approval of vaccines may be due to administrative factors, changes in the leadership of organizational agencies and the need to accurate Security and efficiency From vaccines, especially when concerns arise about harmful effects.
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