Pfizer asks FDA to amend booster authorization to include all adults

Pfizer on Tuesday asked the FDA to amend its booster authorization to include all adults.

Pfizer on Tuesday requested the Food and Drug Administration allow all Americans over 18 to be eligible for booster shots, submitting data from a 10,000-person trial that found its third shots to be safe and effective for adults of all ages.

The request from Pfizer comes six weeks after independent panels of experts at the FDA and Centers for Disease Control and Prevention reviewed the company’s initial request for booster shots and ultimately determined that only Americans over 65 years old or who are frequently exposed to the virus should get a third dose.

That decision, in part, was because experts at the FDA and CDC said they wanted more data on how the third shot might affect young people, and whether they even needed one given the enduring protection from the vaccine against hospitalization and death among that group.

Pfizer’s submission on Tuesday could satisfy that request, providing data on its trial of 10,000 people during the delta variant wave.