What full FDA approval for Covid-19 vaccines really means

Nearly nine months after the first Americans received their shots, the Covid-19 vaccine from Pfizer/BioNTech received full approval from the Food and Drug Administration for people 16 and older on Monday. This could help increase the number of people willing to get vaccines and make it easier to compel those who are less willing — if health officials can cut through the mounting confusion around their efficacy, booster shots, and the threat of the delta variant.

Covid-19 vaccines from Johnson & Johnson, Pfizer/BioNTech, and Moderna have thus far been distributed across the US under emergency use authorizations. This form of limited approval allows the FDA to fast-track the distribution of drugs, vaccines, and medical devices during a public health emergency, like a pandemic.

Getting an emergency use authorization requires data from clinical trials showing that an intervention is safe and effective, but the bar for full approval is higher. Now, with 200 million people at least partially vaccinated, the FDA has effectively removed the asterisks from Pfizer/BioNTech’s mRNA vaccine.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, acting commissioner of the FDA, in a statement on Monday.