Pfizer-BioNTech seeks full FDA approval for COVID-19 vaccine
Pfizer and its German collaborator BioNTech on Friday submitted an application to the Food and Drug Administration for full approval of their COVID-19 vaccine.
Like other vaccines available in the U.S., Pfizer-BioNTech have been providing their vaccine under an “emergency use authorization,” which allowed them to provide safety and effectiveness data after tracking trial participants for an average of two months instead of the usual six months.
In the middle of a pandemic, it was more important to get vaccines to people faster, the FDA said, and vaccine side effects generally occur within the first 4 to 6 weeks after a shot.
But some people have said they aren’t comfortable getting vaccinated because that longer-term data wasn’t available.
Now, Pfizer-BioNTech, whose vaccine has been available since mid-December, has that information and has shown through trials and 132 million shots to Americans that the vaccine can be used safely and effectively to prevent COVID-19.
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No additional safety issues have cropped up with Pfizer-BioNTech’s vaccine since it was authorized, according to the companies and periodic safety reviews by the Centers for Disease Control and Prevention.
Pfizer-BioNTech, which began large-scale trials of the vaccine last summer, will continue to follow participants for two years, to ensure continued safety and effectiveness. It is not yet known how long COVID-19 vaccines will remain effective, though early evidence suggests that they will be protective for at least a year.
The main difference between emergency use authorization and full approval will be psychological, said Norman Baylor, president and CEO of Biologics Consulting and a former FDA official.
“It’s not going to have an effect operationally,” he said. “It could have an effect on perception as far as hesitancy.”
“Increased confidence” is the main benefit of full approval, agreed William Moss, executive director of the International Vaccine Access Center and a professor at the Bloomberg School of Public Health.
“Maybe I’m being hopeful there,” he added.
Before, the FDA could only say the benefits of vaccination have the potentialto outweigh the risks, Baylor said. Full approval, which could come in a matter of days, would be an acknowledgement that benefits definitely outweigh risks.
Full approval also may empower employers to require their workers to get shots. “There’s been at least some reluctance to have mandatory vaccination for a vaccine that’s under an EUA rather than a formal approval,” Moss said.
Emergency use authorizations only last as long as the emergency, and while no one thinks the COVID-19 pandemic is nearing the end, receiving full approval would give Pfizer and BioNTech more of a comfort level that their vaccine will continue to be available, he added.
Contact Karen Weintraub at email@example.com.
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