FDA authorizes fourth Pfizer and Moderna COVID vaccine dose for ages 50 and older

The Food and Drug Administration (FDA) on Tuesday authorized another COVID-19 booster shot for emergency use in people ages 50 and over.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. 

“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

Dr. Peter Marks, head of the FDA office responsible for vaccine safety and efficacy, said the drug regulator did not call an advisory meeting because the decision was “relatively straightforward.”

“This fourth booster dose is something that evidence that we have now from Israel suggests that by getting this, one can reduce the risk of hospitalization and death in this population of older individuals,” Marks said during a call with reporters after the decision.

The CDC published a study in February that showed the effectiveness of the third dose against emergency room visits declined from 87% to 66% against emergency room visits, and from 91% to 78% against hospitalization at four months after receiving the shot.

“That gives me pause for concern that the boosters are not necessarily holding up as well as we’d like,” said Hotez, who strongly supports a fourth dose based on Israeli data showing another booster increases protection for people older than 60.

Americans under the age of 50 can still receive the shot off label at certain health clinics because it has now received FDA authorization, however they would need to convince a doctor or vaccine provider to give it to them.