Breaking: CDC endorses boosters for majority of Americans.

Director goes beyond “evidence panel” recommendations, adding healthcare workers. People over 50 with conditions like obesity and high blood pressure also included.

News and Analysis

NEWS: Boosters for Pfizer’s coronavirus vaccine will now be available to a majority of Americans, according to a CDC press release published after midnight Friday on the east coast (full text below).

Last week, the FDA voted to allow coronavirus booster shots for individuals over age 65 who were more than 6 months out from their “primary” Pfizer vaccinations, but voted down universal boosters.

Yesterday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to recommend boosters for Pfizer recipients ages 65 and older, echoing the FDA panel vote last week.

But CDC Director Dr. Rochelle Walensky signed off on that and more this evening.

Based on Dr. Walensky’s decision, the CDC has now expanded booster recommendations well beyond the initial recommendations of both the FDA and even the CDC’s own advisory committee's votes.

Per the decision memo, people ages 50-64 with underlying medical conditions should (not “may”) receive a Pfizer booster at least 6 months after the primary series. Walensky also rubber-stamped boosters for people ages 18-49 with underlying medical conditions, but that recommendation was less emphatic; such persons may receive a booster based on their individual risks and benefits.

Most newsworthy is that it appears that Dr. Walensky has overridden one of the ACIP votes. The committee voted 9 to 6 against a proposal to allow boosters for adults ages 18-64 with “increased risk for Covid-19 exposure and transmission because of occupational or institutional setting” after 6 months. But the CDC announcement went the other way, stating that individuals in this group "may receive a booster shot...based on their individual benefits and risks."

ANALYSIS: The evidence presented to the FDA and CDC made it clear that the risk of infection and therefore severe disease among fully vaccinated people over 65 is lower after a booster dose of Pfizer's vaccine. What’s unclear is how long that protection lasts. So far, data published in the New England Journal of Medicine from Israel are available to the public for just the first 25 days after a booster. In my personal communications with the research team who published that study, I have been told that the rates of breakthrough infection among the boosted have held steady up to 35 days. (Towards the end of the published study, it was unclear whether the rates of protection were trending up, downtrending, or stabilizing). How long the boosted level of protection will last will determine whether the population benefits are as great as is hoped.

But the case for vaccinations for younger people (other than those who are immunocompromised or who have other extremely high-risk conditions) is less apparent. The data presented to the CDC on Thursday made it clear that the benefit for young adults was likely to be low. It would likely take well over 8 thousand boosted young adults to prevent a single hospitalization. But over time, even that benefit is likely to fade again. Meanwhile, the hope is that any adverse effects will be infrequent enough to justify boosting. The problem is, so far, not enough data exists to assess that question; very little information regarding the safety of 3rd doses was presented to ACIP. That's why they voted boosters down for healthcare workers, though they voted to recommend that adults ages 18 to 49 with "underlying medical conditions" should be permitted to weigh the "risks and benefits" of boosting.

A major problem is not that "underlying medical conditions" is poorly defined. In fact, the CDC has given us a pretty solid definition of who is included: just about everyone.

There are 117 million people ages 50 and over in the United States. When you add people with obesity, high blood pressure, chronic lung conditions like emphysema and moderate or severe asthma (the list goes on), it's apparent that a majority of Americans will now be permitted to get boosters, if they want one. Whether this is wise or not remains unclear, because it's way ahead of the evidence.

Dr. Walensky (who I should mention is a former colleague and mentor to me), said in a statement tonight that the job of the CDC Director is to analyze “complex, often imperfect data to make concrete recommendations that optimize health.” While that is correct, in my opinion, allowing young people to make this call based on the scant information available feels premature and possibly even a little haphazard. Breakthrough infections among the young and healthy are not driving the high numbers of deaths being recorded every day in the United States. Far from it. Data from Pfizer and others suggest that young people remain highly protected by their original vaccine doses. The problem we face remains the millions of Americans who have yet to receive a single dose, let alone the billions around the world who would gladly take a vaccine if it were available to them. Today’s guidance does not solve the most pressing problems we face.

Below is the press release text. Leave your comments and questions below!

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CDC Statement on ACIP Booster Recommendations

Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. The Food and Drug Administration’s (FDA) authorization and CDC’s guidance for use are important steps forward as we work to stay ahead of the virus and keep Americans safe.

This updated interim guidance from CDC allows for millions of Americans who are at highest risk for COVID-19 to receive a Pfizer-BioNTech COVID-19 booster shot to help increase their protection.

CDC recommends:

•people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,

•people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,

•people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and

•people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

Many of the people who are now eligible to receive a booster shot received their initial vaccine early in the vaccination program and will benefit from additional protection. With the Delta variant’s dominance as the circulating strain and cases of COVID-19 increasing significantly across the United States, a booster shot will help strengthen protection against severe disease in those populations who are at high-risk for exposure to COVID-19 or the complications from severe disease.

CDC will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations to keep all Americans safe. We will also evaluate with similar urgency available data in the coming weeks to swiftly make additional recommendations for other populations or people who got the Moderna or Johnson & Johnson vaccines.

The following is attributable to Dr. Walensky:

As CDC Director, it is my job to recognize where our actions can have the greatest impact. 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.

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. This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot. Today, ACIP only reviewed data for the Pfizer-BioNTech vaccine. We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available.

While today’s action was an initial step related to booster shots, it will not distract from our most important focus of primary vaccination in the United States and around the world. I want to thank ACIP for their thoughtful discussion and scientific deliberation on the current data which informed my recommendation.

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