The U.S. Food and Drug Administration (FDA) has formally approved a booster dose of Pfizer’s COVID-19 vaccine for some populations in the United States. The approval allows a third Pfizer dose for those over the age of 65 and adults over 18 at high-risk of severe disease.
The FDA’s latest announcement involves amending the prior emergency use authorization for Pfizer’s COVID-19 vaccine to include a third booster dose to be given at least six months after the second dose. The announcement largely follows the advice laid out earlier this week by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Countering the White House’s prior call for all Americans to be offered vaccine boosters, the VRBPAC recommended boosters currently be limited to the elderly and certain groups at high-risk of severe disease. The ultimate approval by the FDA mostly follows that advice, authorizing boosters for those over 65 or those with health conditions putting them at high-risk of severe COVID-19.
The FDA’s booster decision does include a significant gray area in its third booster approval category offering an extra dose to, “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”
Acting FDA commissioner Janet Woodcock indicates this particular category could include an extraordinarily broad array of Americans. This may include, “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”
The specific details of who may be included in these general categories falls to another advisory panel, the Advisory Committee on Immunization Practices (ACIP), which is in the midst of meeting this week to offer recommendations to the Centers for Disease Control and Prevention (CDC). It will be ACIP’s job to work out what constitutes a “high-risk” individual.
As reported by The New York Times, there are currently around 22 million Americans who are six months post their second Pfizer dose. Half of that number are over the age of 65, and much of the other half may indirectly qualify for a booster depending on how broadly the “high-risk” category is defined.
The FDA’s booster approval is limited to the Pfizer COVID-19 vaccine and offers no insight for those Americans previously receiving the Moderna or Johnson & Johnson vaccines. There is currently no advice or approval for booster shots for those vaccines, and there is no suggestion those who initially received the Pfizer vaccine can receive a booster of a different vaccine.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” says Woodcock in a statement from the FDA. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
Source: FDA