Immunization practices

CDC advisory committee examined safety data on COVID boosters before approving them for all adults

Read a summary of the safety data the committee reviewed before voting.

Editor’s note: This story was updated on Dec. 1, 2021, with new information.

In a virtual meeting on Nov. 19, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11-0 to recommend a single COVID-19 vaccine booster dose for those who are 18 and older under the FDA’s Emergency Use Authorization.

Stanley E. Grogg, DO, the AOA’s liaison to the ACIP, has shared additional relevant information about this meeting and the safety data the committee reviewed prior to voting with the AOA. Here is a summary of his report.

Breaking the recommendation down:

ACIP says people over 50 and those over 18 who live in a long-term care facility should receive a booster dose, while people age 18-49 may receive a booster dose based on their individual benefits and risks. Update: On Nov. 29, the CDC updated its recommendation to say that all adults over 18 should receive a booster dose.

Any FDA-approved or authorized COVID vaccine (Pfizer-BionNTech, Moderna or Johnson & Johnson) can be used for the booster dose regardless of the vaccine received for the primary series.

Pfizer’s booster study

Pfizer conducted a study of roughly 10,000 participants who received either a booster shot or a placebo. It found a 95.6% efficacy rate in the boosted group from seven days following the shot.

The adverse events observed following the booster were consistent with those seen in previous studies of the Pfizer vaccine with no safety signal indicated; no cases of myocarditis or pericarditis were observed.

Moderna’s booster study

Moderna conducted a small study of several hundred individuals who received Moderna boosters after receiving two initial vaccine doses more than six months earlier. It found the rates of adverse reactions with the booster dose to be comparable to those observed after dose two of the primary series.

V-safe findings

Over 725,000 booster recipients reported their booster dose to V-safe, the CDC’s web tool where patients can report whether they have side effects or adverse events following vaccinations.

For Pfizer-BioNTech and Moderna, local and systemic reactions and health impacts were reported less frequently following a booster dose than dose two of the primary series.

Generally, the Moderna booster appears to be more reactogenic than the Pfizer-BioNTech booster, regardless of the primary series manufacturer.

VAERS findings summary

During Sept. 22-Nov. 5, 2021, 25.9 million mRNA and 334,000 Johnson and Johnson vaccine booster doses were administered in the U.S.

More than 93% of reports of adverse events to the Vaccine Adverse Event Reporting System (VAERS) following boosters were not serious, a similar rate as reports following the primary series.

The most frequently reported non-serious adverse events were known and well-characterized adverse events associated with COVID-19 vaccination.

No usual or unexpected patterns were observed with respect to reports of deaths following COVID-19 booster vaccination.

There were 54 preliminary reports of myocarditis and myopericarditis; 12 reports met the CDC case definition, 38 reports are under review, and 4 were ruled out.

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