Posted on by Freddie Sanchez

What full approval of Pfizer COVID-19 vaccine could mean for rollout

Maia Anderson Becker Healthcare

Pfizer said May 4 that it will file for full FDA-approval of its COVID-19 vaccine by the end of this month. But what does full approval mean, and will it change the vaccine rollout? 

Seven things to know: 

  1. To get full FDA approval, drugmakers have to submit six months of data, according to ABC 10News San Diego.
  2. It typically takes the FDA about six months to review an application for full approval of a high-priority drug. Pfizer has said it expects a decision from the FDA in the second half of this year.
  3. Gaining full approval would allow Pfizer to market the vaccine directly to consumers.
  4.  Full approval will allow the vaccine to remain on the market after the pandemic is over, according to The New York Times.
  5. Colleges, universities and companies are legally allowed to require their students or employees to get the vaccine if it’s fully approved, ABC 10News reported. The University of California and California State University school systems have said that once COVID-19 vaccines are fully approved, they will require students, faculty and staff members to be vaccinated, the Times reported. The U.S. military has also said it wouldn’t make vaccines mandatory as long as they only have emergency authorization.
  6. Full approval could make it harder for other drug companies to get an emergency use authorization for their COVID-19 vaccines. Federal law says companies can only get emergency authorization if there’s “no adequate, approved and available alternative,” according to ABC 10News. To get emergency authorization for a new COVID-19 vaccine, drugmakers would have to prove their shot is better at tackling virus variants or better for certain populations.
  7. Full approval could help boost confidence in the vaccine, especially in people who are worried about how quickly it was developed, according to the Times.

    “I think people still have concerns about it, even if they know that no corners were cut. It will nudge people to say, ‘OK, it’s been thoroughly vetted,'” Rupali Limaye, a public health researcher at Johns Hopkins, told the Times.