Pfizer and BioNTech applied to the Food and Drug Administration (FDA) for full approval of their COVID-19 vaccine.
More than 134 million doses of Pfizer’s vaccine have already been administered across the U.S. under an emergency use authorization (EUA), according to the Centers for Disease Control and Prevention (CDC). Similarly, more than 109 million doses of Moderna’s and 8.6 million doses of Johnson & Johnson’s COVID-19 vaccines have been administered in the U.S. under an EUA.
An emergency use authorization grants a company permission to use vaccines or other medical products during emergencies such as the COVID-19 pandemic, according to the FDA. To be granted an EUA, the companies still have to submit thorough and robust data, but an EUA for a COVID-19 vaccine requires two months of data, whereas a full approval requires six months of data, according to NBC News.
No COVID-19 vaccine currently has full FDA approval.
Pfizer and BioNTech have initiated a “Biologics License Application” to the FDA for full approval of their COVID-19 vaccine for people 16 years of age and older, the companies announced in a statement on Friday (May 7).
The companies will submit data to the FDA on a rolling basis in the coming weeks, including information about manufacturing and facilities; they have already submitted the most recent analysis of their phase 3 trial that includes up to six months of data on efficacy and safety gathered after participants received their second dose.
They will also request a priority review, which if granted, would expedite the review process from around 10 months to six months, according to the FDA.
A full approval could help with vaccine hesitancy and even impact vaccine mandates, as some schools and organizations have said they’ll require COVID-19 vaccination but only once the FDA fully approves a vaccine, according to CNN.
The main difference between an EUA and a full approval will be psychological, Norman Baylor, president and CEO of the company Biologics Consulting and a former FDA official, told USA Today. “It’s not going to have an effect operationally,” he said. “It could have an effect on perception as far as hesitancy.”
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What’s more, an EUA is granted only so long as the emergency continues and there are no approved alternatives; but once a vaccine is given full approval, it can be administered if the pandemic de-escalates enough to lose its emergency designation.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. government,” Albert Bourla, Pfizer’s CEO said in the statement. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
Pfizer/BioNTech also applied to expand its EUA to include children between the ages of 12 and 15 after a clinical trial found the vaccine was 100% effective in preventing COVID-19 among participants in that age group.
Originally published on Live Science.
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