FDA clears Pfizer COVID-19 vaccine boosters for vulnerable groups

The Food and Drug Administration approved a third dose Pfizer/BioNTech COVID-19 vaccine to be administered to people from certain vulnerable groups. This is the second booster for United States vaccination efforts.
The agency approved boosters for people aged 65 and over, people at high risk for severe diseases, health care workers, as well as other people who are high-risk of being exposed to COVID-19 at their workplace.

This decision comes one month after the Biden administration had announced that booster shots would soon be available in the US. Scientists and public health professionals criticized the administration at the time for promoting booster shots before there was any clear evidence they were needed and before the FDA and CDC had approved their use. According to The New York Times, federal officials informed the White House in September that they might have to change or back the booster plan, while data collection and review by health agencies took place.

At this time, there are not updated guidelines for Moderna or Johnson & Johnson shots.

This decision applies only to the Pfizer / BioNTech shots. There are no updated guidelines available for Moderna or Johnson & Johnson shots.

Experts debated over the past weeks whether third doses of Moderna COVID-19 and BioNTech vaccines were required. The US and Israel data suggests that the protection against the coronavirus declines over time. However, different estimates about how steep this decline may be differ. Older people are more affected. The majority of data indicates that even though they are otherwise healthy, those who receive two doses of the vaccine are still protected from severe illness.

On Friday, the FDA's advisory committee on vaccination voted against boosters for people older than 16 years. They cited limited evidence to support boosters in younger age group. The lack of safety data for third doses in younger patients also irked members. The committee recommended boosters only for those over 65, or at high risk of severe COVID-19. It also supported boosters for workers at high risk and health care workers in a less formal poll.

The majority of data used to support or oppose boosters came from countries outside the US. These countries have central health care systems they can draw from to analyze big-picture COVID-19 trends. Because the US does not have such an infrastructure, vaccine information is often more fragmented.

The current discussion by the CDC about collecting data on vaccines only reveals the extent of the U.S. collection. It all comes down to our fragmented IT infrastructure. It is comparable to data from the U.K.'s NHS. Matthew Herper (@matthewherper), September 17, 2021

Everybody over 12 years old can receive a third dose of the COVID-19 vaccination in Israel. Since July, Israelis over 60 have been able to receive a third dose of the COVID-19 vaccine. Pfizer / BioNTech released data this week indicating that while the protection against infections had declined for the group that was the first to receive the vaccines, the third dose increased the protection to 95 percent. The United Kingdom announced this week a booster program, which will offer third shots to those over 50.

Experts worry that the US and other rich countries are seeking third doses of vaccines when they are scarce in many parts of the globe. To prioritize doses for low-income countries, the World Health Organization has requested a moratorium in boosters from now until the end.

Thursday's meeting of the advisory committee for the Centers for Disease Control and Prevention will discuss whether it recommends the third shot now authorized and for whom. This committee would define and refine the criteria for boosters under the FDAs decision.