The Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended Thursday that Americans aged 65 and older or otherwise at high risk from COVID-19 get a third dose of the Pfizer vaccine.
The Food and Drug Administration (FDA) granted formal approval to a third booster dose for seniors, those at high risk of severe COVID-19 and those at high risk of exposure due to their occupation Wednesday evening. The ACIP recommendation is the final hurdle for the boosters before CDC director Rochelle Walensky can officially grant a CDC recommendation, which will result in the boosters becoming widely available to the approved recipients.
The ACIP voted against the booster recommendation for those at high risk of exposure via their occupation, but otherwise roughly mirrored the FDA’s approval.
Walensky is expected to confirm the CDC’s recommendation of the third dose imminently.
Today, we amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least 6 months after completion of the vaccine’s primary series in certain populations. https://t.co/xF8h0kmF61 pic.twitter.com/3dsIhM9MoV
— U.S. FDA (@US_FDA) September 22, 2021
On Sep. 17, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the FDA approve boosters for seniors and high risk individuals after reviewing data from Pfizer and researchers from American agencies, the United Kingdom and Israel. Pfizer had requested approval for boosters to be given to all Americans aged 16 and over, but VRBPAC members expressed concern about the safety of the third dose for young men and the necessity of a booster for those who aren’t at high risk.
The ACIP recommendation includes a caveat for those under age 65. Those aged 50-64 with underlying health conditions are recommended to get a booster, while those aged 18-49 with an underlying condition are recommended to do so “based on individual benefit and risk.”
President Joe Biden had pressured the FDA to make boosters available to all Americans, including promising they would be recommended by the end of September. The more limited approval by the FDA and recommendation by the CDC ensures that Biden’s goal will not be met. (RELATED: Fauci Flips On Boosters, Now Says It’s Not A ‘Mistake’ For FDA To Limit Recommendations)
Two top vaccine officials announced they will resign from the FDA in recent weeks, reportedly due to the pressure placed on the agency by the Biden administration and the CDC to rush the booster approval process. Those two officials, who are remaining in office until later this year and were involved with the booster approval decision, signed a letter in the Lancet last week arguing that boosters may be beneficial for high risk groups, but are not needed at this time for the general population.
Despite disagreement within the scientific community, some countries, including Israel, have already been administering booster doses for weeks.