But the FDA’s own panel of vaccine advisers voiced concerns over gaps in the data supporting broad need and safety for booster shots in a meeting last week, and ultimately endorsed the limited authorization for the shots.
“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines,” Dr. Peter Marks, the FDA’s top vaccines official, said in a statement.
“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” Marks said.
The FDA’s decision currently applies only to people who received both doses of Pfizer’s COVID-19 vaccine at least six months ago. The regulator has yet to authorize Moderna or Johnson & Johnson booster shots, though federal health officials have said they expect most Americans will eventually need an additional dose. Moderna only recently submitted to the FDA data supporting a booster dose of its COVID-19 vaccine. It halved its third dose from 100 micrograms to 50 micrograms. Pfizer’s booster shot is the same as the first two doses. Johnson & Johnson recently announced data from its vaccine trials suggesting the single-shot Janssen vaccine remained mostly effective at preventing severe disease but also that a second dose could boost protection.
Scientists at the National Institutes of Health are also working to release data from trials in which they mix-and-match booster shots. The results are expected to be announced as early as this month.
“We are right in the middle of those trials to see, can you mix and match any one of the three that have emergency use authorization, can you start with one and boost with the others? We’re going to know more about that just in the course of the next two or three weeks,” NIH Director Francis Collins told “Face the Nation” on Sunday.
Pfizer and its German partner BioNTech had initially sought full approval of its booster shot doses in all adults and teenagers at least 16 years old, citing promising data from its own trials and other countries that have administered third doses.
Meanwhile, the FDA remains without a permanent leader, according to Kaiser Health News reports. President Biden has yet to nominate a commissioner, confusing public health officials. Biden has to be careful choosing a nominee given the split Senate, which would need to confirm the person.