Deadlines for FDA approval for Moderna and J. & J. Vaccines remain unclear

Now that the Pfizer-BioNTech coronavirus vaccine has been administered full federal approval for use in persons 16 years of age and olde...


Now that the Pfizer-BioNTech coronavirus vaccine has been administered full federal approval for use in persons 16 years of age and older, attention turns to vaccines manufactured by Moderna and Johnson & johnson.

Both vaccines have been available to the American public for months under emergency use approvals from the Food and Drug Administration. Moderna applied for full approval in June, a month after Pfizer, and Johnson & Johnson are expected to apply soon.

It’s unclear when they might be fully approved. Dr Peter Marks, the FDA’s primary vaccine regulator, declined to specify a timeline for Moderna’s approval during a call with reporters Monday.

Dr Marks noted that approval of Pfizer’s vaccine took just 97 days from the time the company submitted its data, less than half the time of a typical approval period. The comprehensive process was sped up by a “tireless team” who “worked day and night to make it happen,” he said, adding that regulators were “very stringent” despite the short deadline.

Dr Anthony S. Fauci, the nation’s foremost infectious disease expert, said in a series of interviews on Tuesday that he hoped the FDA would soon be able to move forward to fully approve the next vaccine.

“I don’t think it’s too far,” Dr Fauci said on the CBS program.This morning. “

“I think it’s a timing issue,” he continued. “I don’t think there is necessarily anything different in the process, it’s just that they submitted or are submitting their material a little later or after Pfizer.”

Full federal approval could make vaccines more acceptable to the more than 80 million people across the country who have yet to be vaccinated, Dr Fauci said on “Morning JoeOn MSNBC, citing a survey that found that about a third of them waited for the imprimatur from the FDA before getting vaccinated.

Dr Fauci also said he believed that advertising for the vaccine, which is cleared now that it has been approved, could increase adoption, and that this approval would further boost the vaccine mandates of companies, colleges and local governments.

President Biden encouraged such mandates in a speech Monday. The Pentagon has announced that it will require the 1.4 million active-duty soldiers to be vaccinated, New Jersey said all teachers should have weekly injections or tests, and the State University of New York announced a vaccination requirement for its students.

Mandates for vaccination and other protective measures have become increasingly urgent as the highly infectious Delta variant has led to an increase in the number of cases nationwide and overwhelmed hospitals in many states. The seven-day average of known coronavirus-related deaths topped 1,000 for the first time since March 2021, according to collected data by the New York Times.

From September 20, the federal government plans to provide booster injections for people eight months after their second dose of vaccine, assuming federal regulators clear additional doses.

Nearly 65 million people have been vaccinated with Moderna’s vaccine and nearly 14 million with Johnson & Johnson’s, compared with more than 92 million people who have been vaccinated with Pfizer’s vaccine, according to data from the Centers for Disease Control and Prevention. Just over 60 percent of people eligible for the vaccine in the United States have been fully immunized.

Children between the ages of 12 and 15 can still receive Pfizer’s vaccine under the Emergency Use Authorization; none of the vaccines have been authorized for children under 12 years of age.

In July, federal regulators urged Pfizer and Moderna to expand trial size in children 5 to 11 years old to detect rare side effects, including problems with inflammation of the heart that have appeared in people under the age of 30. Pfizer seemed to be on a faster path to obtaining emergency use authorization for young children at the time.

Dr Fauci said drug companies and federal agencies are still collecting data on vaccine use in children under the age of 12, and he hoped the FDA could at least clear the vaccines for use. emergency in children at the beginning of winter.

Speaking on “The Today Show” on NBC, Dr Fauci said he believed ending the pandemic in the United States would involve convincing the “overwhelming majority” of unvaccinated people to get vaccinated.

“I believe we can see the light at the end of the tunnel,” Dr Fauci said. “When we reach a point where there is enough protective veil over the community, you see a dramatic decrease in not just cases, but hospitalizations and, ultimately, of course, deaths. “

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Newsrust - US Top News: Deadlines for FDA approval for Moderna and J. & J. Vaccines remain unclear
Deadlines for FDA approval for Moderna and J. & J. Vaccines remain unclear
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