The U.S. Centers for Disease Control and Prevention approved booster shots of the Pfizer COVID-19 vaccine for some Americans early Friday morning.
CDC director Dr. Rochelle Walensky broke from the agency’s independent vaccine advisers to recommend boosters for a broader group of people — those ages 18 to 64 who are at increased risk because of their workplaces or institutional settings — in addition to older adults, long-term care facility residents and some people with underlying health conditions.
The CDC also endorsed the vaccine advisers’ recommendation of boosters for people ages 18 to 49 with underlying medical conditions.
The CDC guidance includes the recommendations made by its Advisory Committee on Immunization Practices –a panel of outside vaccine experts – on Thursday, when the committee voted to recommend boosters for people 65 and older and residents of long-term care facilities who received the Pfizer COVID-19 vaccine at least 6 months ago, and people ages 50 to 64 with underlying medical conditions.
However, ACIP members after two intensive days of hearings voted 9-6 against recommending boosters for people ages 18 to 64 who were at greater risk because they are health care workers, caregivers for frail or immunocompromised people, or work in homeless shelters and correctional facilities. The committee argued that such a recommendation would open the gates to virtually any adult who wanted a booster shot because a “high-risk” position is undefined.
Walensky’s ruling means the CDC’s guidelines for how to administer booster shots will fall in line with what the Food and Drug Administration recommended earlier this week.
The FDA had earlier given emergency-use authorization that also allows boosters for people 18 and older whose occupational exposure to the SARS-CoV-2 virus puts them at elevated risk of serious complications. Booster doses can be given any time at least six months after a person received their second shot, the FDA said in a statement.
Acting FDA Commissioner Janet Woodcock said the authorization would allow people such as teachers and day care staff, as well as health care and grocery workers, to get the third shot.
The authorization applies only to the Pfizer-BioNTech shot, the agency said.
So, to be clear, the FDA and the CDC recommend that those that should get boosters are:
n People ages 65 and older, six months after vaccination.
n Long term care residents, six months after vaccination.
n People ages 50 to 64 with underlying health conditions, six months after vaccination.
n People ages 18 to 49 with underlying conditions should weigh their individual benefits with risks.
n People working in high exposure occupations (such as prisons and jails, health care workers, teachers, first responders), six months after vaccination. The list could also include store clerks and anybody who interacts with the public.
The emergency clearance is line with a recommendation last week from FDA advisers but narrower than the full approval that Pfizer and its German partner had sought. It means that the Biden administration will have to move more slowly on its planned wider rollout of boosters proposed last month. Third doses were previously authorized for certain people with compromised immune systems.
While less broad than some had hoped, the authorization leaves the door open for the FDA to consider broader use of boosters, including in younger adults, as more data on their safety and efficacy become available. And it assures that many of the older Americans who were first in line for the initial shots will be among the earliest to get additional protection.
A surge in virus infections caused by the delta variant has coincided with fears that vaccine potency will fade as the weather turns colder.
Scientists have been divided on the need for boosters. Real-world studies suggested that the efficacy of the Pfizer vaccine diminished somewhat this summer, especially in preventing mild breakthrough cases, though it is hard to distinguish waning immunity from the effects of the highly infectious delta variant.
But other data have suggested that the shot provides lasting protection against severe disease leading to hospitalization and death, and some researchers have said that boosters for most people could be put off for some time.
Since the FDA said Aug. 13 that people with weakened immune systems can receive a third shot, more than 2 million Americans have gotten one, according to CDC data.
Use of a third shot to protect vulnerable people was backed by recent evidence from other countries. An Israeli study in the New England Journal of Medicine showed a third dose of the Pfizer vaccine can dramatically cut rates of COVID-related illness in people 60 and older.
Additionally, a Pfizer study suggested that the efficacy of its first two shots waned in a matter of months, and that booster doses are an effective way to combat the spread of the virus and new variants.
Some critics have said that booster shots should wait until immunizations are more widespread globally. World Health Organization Director-General Tedros Adhanom Ghebreyesus has argued that uneven vaccine distribution will be the world’s biggest obstacle to ending the pandemic and recovering.
Prior to last week’s meeting of the vaccine advisory panel, top scientists and two FDA officials, in a review published in The Lancet, questioned the scientific support for a third shot, saying available doses would be better used to immunize the unvaccinated.