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Pfizer and BioNTech have already started their application process for full U.S. approval of their Covid-19 vaccine. Rival Moderna is expected to submit for the same process for its shot later this month.
The mRNA vaccines are currently on the U.S. market under Emergency Use Authorizations, which were granted by the Food and Drug Administration in December. Since then, more than 263 million shots have been administered, according to data compiled by the Centers for Disease Control and Prevention.
Standard vaccine reviews generally take several months to a year or more to determine whether it is safe and effective for use in the general public. But due to the pandemic, which has killed nearly 600,000 Americans, the FDA permitted the use of the shots under an EUA.
In a public health emergency, the manufacturing and approval of vaccines can be streamlined through emergency authorizations. Former Health Secretary Alex Azar declared a public health emergency on Jan. 31, 2020. The health emergency has been renewed several times, most recently in late April. The FDA allowed the use of the shots with just two months of safety data under an EUA. It’s not the same as a Biologic License Application, or a request for full approval, which requires at least six months of data.
“The way that works is the companies have to submit in this case for a vaccine, a Biologics License Application, and that goes through somewhat more review, obviously than an EUA would,” acting FDA Commissioner Dr. Janet Woodcock said on SiriusXM on April 30. “And there are more manufacturing controls that are standard that are looked at and so forth.”
Full approval will be beneficial to the companies for multiple reasons, former FDA commissioner Dr. Robert Califf told CNBC. For one, it will allow the companies’ vaccines to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency,” he said.
It also sets the stage for the companies to begin marketing the shots directly to consumers, he said. Companies can’t promote their products under an EUA, he said.
“The vaccines will still have to be administered under the supervision of a professional who’s qualified,” added Califf, who was the agency’s commissioner under the Obama administration beginning in early 2016. “It’s not like they can send the vaccines to people’s homes. However, they can advertise on TV and promote their products under the watchful eye of the FDA.”
U.S. approval can also have far-reaching impacts beyond the companies who submit the applications, FDA advisors and health policy experts told CNBC.
It could encourage more businesses, universities and other organizations to start requiring people to get the shots, they said, an already controversial move that has impacted millions of students and employees across the U.S. It may also raise confidence in the vaccines and combat vaccine hesitancy, they said.
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