Company asks FDA for full approval

Pfizer and its German associate BioNTech filed an application with the Food and Drug Administration for full approval of their COVID-19 vaccine on Friday.

They announced that they will be submitting data to the FDA on an ongoing basis over the coming weeks with a request for priority review. It is not clear how long this review will take.

Like other vaccines available in the US, Pfizer-BioNTech provided its vaccine under an “Emergency Authorization” that allowed them to provide safety and efficacy data after subjects were followed up for an average of two months instead of the usual six months.

Getting vaccines to people faster was more important in the midst of a pandemic, the FDA said, and vaccine side effects generally occur within the first 4 to 6 weeks of a shot.

But some people have said they feel uncomfortable about being vaccinated because that longer-term data was not available.

Now Pfizer-BioNTech, whose vaccine has been available since mid-December, has this information and has shown it in studies and studies 134 million shots to Americans that the vaccine can be used safely and effectively to prevent COVID-19.

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According to the companies and regular safety reviews by the Centers for Disease Control and Prevention, there have been no additional safety issues with Pfizer-BioNTech’s vaccine since it was approved.

“We are proud of the tremendous progress we have made in working with the US government to deliver vaccines to millions of Americans since December,” said Albert Bourla, Pfizer CEO, in a statement. “We look forward to working with the FDA to complete this ongoing filing and support its review with the aim of ensuring full regulatory approval for the vaccine in the months ahead.”

The permit is valid for people aged 16 and over. Although companies expect that FDA every day so they can start making their vaccine available to children ages 12-15They will not apply for full approval for this age group until they have six months of data.

Pfizer-BioNTech, which started large-scale studies with the vaccine last summer, will continue to accompany participants for two years to ensure safety and effectiveness. It is not yet known how long COVID-19 vaccines will last, although early evidence suggests they will protect for at least a year.

The main difference between emergency approval and full approval will be psychological, said Norman Baylor, president and CEO of Biologics Consulting and a former FDA official.

“It won’t have any operational impact,” he said. “It could be perceptual to the point of hesitation.”

“Increased Confidence” is the main benefit of full approval, agreed William Moss, executive director of the International Vaccine Access Center and professor at the Bloomberg School of Public Health.

“Maybe I’m hopeful there,” he added.

Previously, the FDA could only say that the benefits of vaccination have the potential to outweigh the risks, Baylor said. Full approval would be an affirmation that the benefits definitely outweigh the risks.

Full approval can also enable employers to require their workers to get gunshots. “There has been at least some reluctance to make vaccine mandatory for a vaccine that is subject to an EEA, rather than formal approval,” Moss said.

Emergency permits only last as long as the emergency, and while no one believes the COVID-19 pandemic is nearing its end, full approval would be more convenient for Pfizer and BioNTech than their vaccine will continue to be available, he added.

Contact Karen Weintraub at [email protected].

U.S. TODAY health and patient safety coverage is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide any editorial contributions.


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