What full FDA approval this fall means for COVID vaccines going forward

July 22, 2021, 6:00 PM UTC

President Biden said Wednesday he thinks the Food and Drug Administration will give full approval for vaccines as soon as this fall.

At a town hall in Ohio, Biden said the FDA would soon fully approve COVID-19 vaccines, which up to now have only been authorized for emergency use.

“My expectation talking to the group of scientists we put together, over 20 of them plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval,” Biden said.

There is some evidence that full approval for Covid vaccines could push more people to get vaccinated. A vaccine monitoring report by the Kaiser Family Foundation from June found that 31% of unvaccinated adults said they would be more likely to get the vaccine if one of the shots that is currently authorized for emergency use received full approval.

Full approval would have the strongest effect on people that are unvaccinated and said they would “wait and see” before getting the vaccine, said Kaiser Family Foundation Senior Survey Analyst Lunna Lopes.

“One of the big concerns they have is the safety of vaccine, and how quickly it was developed, and just the newness of vaccine,” Lopes said. “Full FDA approval could kind of nudge some of those people who are currently unvaccinated and in that ‘wait and see’ group towards getting the vaccine.”

Despite indications that full FDA approval may push some people to get a Covid vaccine, Lopes said there is still confusion about the difference between emergency authorization and full FDA approval. According to the foundation’s report, “two-thirds of adults (including a large majority of unvaccinated adults) either believe the vaccines currently available in the U.S. already have full approval from the FDA or are unsure whether they have full approval or are authorized for emergency use.”

The difference between emergency use authorization and full approval is something most Americans were likely unfamiliar with until the first emergency use authorization for coronavirus was granted to the Pfizer-BioNTech COVID-19 vaccine in December 2020. Since then, both the Moderna and Johnson & Johnson (Janssen) vaccine have also received emergency approval.

The power to give emergency authorization was granted to the FDA by Congress in the early 2000s with one of the intention of protecting the military against anthrax attacks post-911. Similar authorizations have been issued to experimental therapies for swine flu (H1N1), Middle East Respiratory Syndrome (MERS), Zika, and Ebola.

Under emergency use authorization, the FDA can allow the use of unapproved medical products to diagnose, treat, and prevent serious and life-threatening diseases for which there are no approved alternatives.

Yet, this authorization doesn’t imply that vaccines aren’t rigorously tested. Tens of thousands of study participants have helped prove the effectiveness of vaccines in strict clinical trials that follow FDA standards. Emergency use authorization simply speeds up manufacturing and administrative processes.

Pfizer applied for full approval for its vaccine in early May and Moderna in early June. Johnson & Johnson has yet to apply, but is expected to do so soon. To determine FDA approval, the regulatory agency will review much more data over a longer period of time than it did for the emergency use authorizations. It will also review manufacturing and quality control.

On July 16, the FDA accepted Pfizer’s application for full approval and labeled it “under priority review,” according to Science Magazine. This means that the application will theoretically be approved faster than the typical 10 months it would usually take. The FDA has not formally accepted Moderna’s application.

At the same town hall Wednesday, Biden said he expects children younger than 12, who can’t currently get the vaccine, to be eligible soon on an emergency basis, although the FDA has said it doesn’t expect that to happen until the winter.

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