Some people hesitant to get a COVID vaccine point to the fact that they haven’t gotten full Food and Drug Administration approval yet. So when will that happen?
Let’s connect the dots.
EUA right now, applications filed
Right now, the COVID-19 vaccines being used in the United States do not have full FDA approval, but instead they have something called emergency use authorization. It does not mean they are not safe and effective. The vaccines have been through rigorous clinical trials.
Pfizer submitted its application for full approval in May, and Moderna began a rolling submission in June. Johnson and Johnson has said it will submit its application later this year.
Several months to review documents
Typically, it takes the FDA several months to give full approval to a vaccine. In an interview with the Washington Post, the agency’s top vaccine official said the process involves going through hundreds of thousand of pages submitted by the companies. In order to put the COVID vaccines on the fast track for full approval, the FDA is stopping other work to prioritize getting these applications done.
Full approval, easier mandates
The FDA is not giving a timeline yet but some experts estimate Pfizer could get full approval by the fall. Whether that will persuade vaccine skeptics is still uncertain, but lawmakers and health experts note that official FDA approval could help universities and local government impose vaccine mandates.