The Centers for Disease Control and Prevention is expanding eligibility forvaccine booster shots to all adults ages 18 and up. The agency published its new recommendations Friday, as health officials sound the alarm over around the country.
"Booster shots have demonstrated the ability to safely increase people's protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays. Based on the compelling evidence, all adults over 18 should now have equitable access to a COVID-19 booster dose," CDC Director Dr. Rochelle Walensky said in a statement.
In its updated guidance, the agency says recipients of the Pfizer or Moderna vaccines who are age 50 or older, or in long-term care settings, "should" receive a third dose six months after their second dose. All other adults "may" receive a booster shot after six months.
The decision followed a unanimous vote by the CDC's outside panel of advisers backing the move. Earlier Friday, the Food and Drug Administration cleared the way by updating the vaccines' emergency use authorizations.
All adult recipients of Johnson & Johnson's COVID-19 vaccine can already receive booster shots, two months after their first dose.
"There was not a single state that voiced opposition to this move. Our summary and rationale was that the current guidelines, though well intentioned and thoughtful, generate an obstacle to uptake of boosters. In pursuit of precision they create confusion," Dr. Nirav Shah, Maine's top health official and president of the Association of State and Territorial Health Officials, told the panel Friday.
"Our concern is that eligible individuals are not receiving boosters right now, because of this confusion," said Shah.
Under the previous guidance, boosters were recommended for people in higher-risk groups, which many critics called confusing. A growing number of state and local officials wereto all adults.
Pfizer said data from its clinical trial showed the booster was at preventing symptomatic infection, compared to vaccinated people who had not received a third dose.
"We're going to look back and say that the proper regimen likely should have been a three shot regimen," Dr. Anthony Fauci, the president's chief medical adviser, told a virtual event hosted by the group ThisIsOurShot this week.
"Not two shots and the third shot is a bonus, or the third shot is an extra add-on. It should be part of the primary vaccination regimen," said Fauci.
A handful of state governors have also urged the CDC to change its definition of "fully vaccinated" to require the third dose, as some other countries have announced plans to do.
However, a semantic decision by the agency's advisers on Friday could complicate any federal revisions to who counts as "fully vaccinated." The advisers chose to recommend that adults younger than 50 "may receive" instead of "should receive" the third dose, acknowledging some outstanding questions over data on the benefits and risks of boosters.
"A 'should' is something that is then taken by others than us to mandate such things and also to make people feel that they haven't done the right thing," said Dr. Sarah Long, one of the members of the CDC's Advisory Committee on Immunization Practices.
The CDC and FDA's advisers had initially balked at a request from Pfizer earlier this year to expand booster shot eligibility to all adults, citing concerns over limited data demonstrating the need for additional doses and potential risks of myocarditis, a rare type of heart inflammation linked to the shots in mostly younger men.
But the Biden administration's top doctors renewed their push to expand booster shot eligibility in recent weeks, as Europe has faced a new surge of hospitalizations from the virus and cases are once again beginning to climb across the U.S.
Federal regulators also pointed to "additional real-world data" from the U.S. and other countries that have already rolled out Pfizer and Moderna's third doses, enabling the FDA to "reassess the benefits and risks of the use of these vaccines in the general adult population."
"Although the myocarditis has not been severe, we were able to get a fair amount of data from Israel on the Pfizer vaccine, showing that myocarditis after the third dose, which was more remote in time than the second dose, was much lower than the second dose," Acting FDA Commissioner Dr. Janet Woodcock said Friday at a Stanford University webinar.
Woodcock acknowledged the agency still does not "have full data on a third dose of the Moderna vaccine" and rates of myocarditis, but pointed to the lower dosage of Moderna's booster and longer interval since the second shot for easing the agency's concerns.
"We still have things to learn and we will be doing surveillance and have required the companies to also do surveillance to look at this side effect," added Woodcock.
So far, federal health officials told the panel that the agency has not seen any new safety concerns in nearly 26 million Pfizer or Moderna booster doses. Side effects were reported more frequently after Moderna's third dose than Pfizer's, the agency tallied, but were less common after the third dose than after the second.
"Consistent with findings on reactogenicity following a primary series, generally Moderna boosters appear to be more reactogenic than Pfizer BioNTech booster regardless of the primary series manufacturer," the CDC's Dr. Tom Shimabukuro told the panel.
The FDA and CDC's moves to greenlight third doses for all adults come as states are racing to accelerate booster shots ahead of the winter holidays.The pace of the nationwide rollout has slowed in recent weeks and some states are already seeing surges in hospitalizations.
Some governors have faulted the Biden administration's process on boosters for moving too slowly and imposing narrower guidelines earlier this year that may have discouraged potential booster recipients.
Nearly two months since Pfizer's booster shots were recommended for adults 65 and older, the CDC's data tallies only four states — Iowa, Colorado, Minnesota, and Vermont — where at least half of seniors have gotten the additional shot.
"We clearly understand that the prior FDA groups were complicated to implement. Importantly, simplification of our booster dose recommendations will reduce confusion and allow health care providers and the public health workforce to focus on high priority groups for boosters," the CDC's Sam Posner acknowledged Friday, introducing the panel's meeting.
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