CDC Panel Backs Pfizer Booster Dose for People Ages 65 and Older
CDC Weighs Pfizer Boosters After FDA Approval for Some Americans
(Bloomberg) -- The Centers for Disease Control and Prevention adopted the use of booster shots in the U.S. for people at high risk of contracting or falling seriously ill from Covid-19, overruling a narrower recommendation from the agency’s advisers and clearing the way for a widespread vaccination campaign.
Millions of Americans who were immunized with the Pfizer Inc.-BioNTech SE vaccine at least six months ago should receive a booster dose, including those aged 65 or older, those in long-term health care facilities and those aged 50 to 64 with underlying medical conditions, the agency said in a statement. People aged 18 to 49 with medical conditions and those who are at high-risk for being exposed to the virus at their workplaces or elsewhere may also receive a third dose.
The endorsement from CDC Director Rochelle Walensky will allow shots to be given immediately. She said the decision, which aligns with the Food and Drug Administration rather than an expert team of reviewers at the CDC, was based on imperfect data and designed to protect those at highest risk as the delta variant continues to spread in the U.S.
“In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,” Walensky said in the statement. “I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to Covid-19.”
The CDC’s Advisory Committee on Immunization Practices earlier on Thursday recommended the shots only for people most vulnerable to severe disease. It voted against an extra dose for people whose work exposes them to the virus. That put them at odds with the FDA, which issued an emergency authorization of boosters for the broader group of recipients of the Pfizer-BioNTech shot.
Boosters are becoming more widely available at a crucial time, as the U.S. fights a surge of infections driven by the highly contagious delta variant of Covid. While the unvaccinated account for the vast majority of the most seriously ill in the current outbreak, breakthrough infections among the vaccinated have fueled concerns that the shots’ efficacy may wane over time.
Some of the CDC advisers rejected the idea of giving workers and people in other risky settings ages 18 to 64 access to booster shots in part because of the message it might send. The rift reflects an unresolved divide in the wider scientific community over whether boosters are needed, or when they might be most usefully deployed.
Weak Data
A presenter at the meeting from the CDC noted weaknesses in the data from Israel that had been used to support the use of boosters. Walensky acknowledged at the outset of the meeting that the data weren’t “perfect,” and that the panel had been given a difficult task.
Many of the panel members were also concerned that encouraging boosters could damage broader uptake of Covid vaccines. Several emphasized that raising the level of primary vaccinations should remain the top public-health goal in the pandemic. So far, 75% of Americans who are eligible have received at least one dose, according to CDC data.
There was worry as well, especially with regard to extra doses for younger people, that the committee was merely throwing additional vaccines at the public to relieve Covid-related anxiety, not because of any actual medical or public-health need.
“We might as well just say lets give it to everyone 18 and over,” said Pablo Sanchez, an ACIP member who teaches pediatrics at Ohio State University. “I think we have a really effective vaccine and it’s like saying that it’s not working, and it is working.”
Moderna, J&J
Another issue raised at the meeting was whether supplemental doses should be under consideration for recipients of the Moderna Inc. and Johnson & Johnson shots.
The FDA has yet to clear additional doses for either of those vaccines, and ACIP won’t discuss mixing and matching of different shots until a future meeting. But panelists expressed fears that older and vulnerable people who had received those shots were being left with no alternatives in the interim.
Walensky said those shots would be reviewed as quickly as possible.
“We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available,” she said.
Americans have been able to get an additional vaccine dose since Aug. 13, when regulators authorized them for the immunocompromised. Since then, more than 2.3 million third doses have been administered, though it’s unclear how many of those went to people with weak immune systems, as opposed to people who just wanted a chance to bolster a previous vaccination but didn’t have an underlying vulnerability.
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