The FDA didn’t think it was a good idea to authorize a third dose of the Pfizer-BioNTech COVID-19 vaccine for a wide swath of the U.S. population. But the head of the CDC just signed off on an order to recommend the booster shot to millions of Americans, including those in high-risk occupations, despite opposition from the agency’s own advisory panel.
Last Friday, the FDA’s vaccine advisory committee voted against a proposal to authorize a third Pfizer shot for the general population except for people older than 65 and those with underlying medical conditions.
The CDC’s Advisory Committee on Immunization Practices met on Wednesday to determine exactly who should get the booster shot and handed their non-binding recommendations to the CDC Director Dr. Rochelle Walensky on Thursday.
The CDC panel endorsed giving extra Pfizer shots to people 65 and older, nursing home residents and adults with medical conditions such as pregnancy, HIV, cancer, diabetes, obesity or heart disease. However, the panel voted 9-6 against giving booster shots to healthy adults who face a high risk of exposure to COVID-19 at their workplace.
On Friday morning, Walensky signed off on a series of recommendations from the CDC panel. And, in an unusual move, she cleared boosters for people in high-risk occupational and institutional settings as well.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Walensky said in a statement on Friday. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Here’s what the CDC recommends:
- People aged 65 years and older, residents in long-term care settings and people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after completing their two-shot series
- People aged 18–49 years with underlying medical conditions may receive a booster shot, depending on their individual benefits and risks
- People 18-64 who are at increased risk for COVID-19 exposure because of occupational or institutional setting may receive a booster shot based on their individual benefits and risks
New Pfizer data submitted to the FDA showed that vaccine protection starts to drop about four months after the second dose. Most health care workers and those working at high-risk settings in the U.S. completed their two-shot series in December and January, making them more vulnerable in the latest wave of COVID-19 infection.
However, scientists on FDA’s advisory panel were concerned about Pfizer’s lack of safety data on the third booster shot and the fact that the data had not been peer-reviewed.
“These data are not perfect, yet collectively they form a picture for us, and they are what we have in this moment to make a decision about the next stage in this pandemic,” Walensky told CDC advisors on Thursday before their vote.
She said the CDC will move “with the same sense of urgency” on recommendations for Moderna and Johnson&Johnson booster shots as soon as that data is available.