Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky endorsed an independent expert panel's recommendation to use the Pfizer COVID-19 vaccine for people 16 years and older under full FDA approval. The panel’s standard recommendation on Monday followed its interim recommendation given under emergency approval.
The COVID-19 Vaccine Safety Technical (VaST) Work Group, which presented during the Advisory Committee on Immunization Practices (ACIP) meeting Monday, reiterated an increased risk of heart inflammation among vaccinated males under 30, but maintained that the shot’s benefits far outweigh any potential risks.
The vote was 14-0.
"We now have a fully approved COVID-19 vaccine and ACIP has added its recommendation," Walensky said in a written statement. "If you have been waiting for this approval before getting the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated."
Committee members were tasked with discussing the following question:
Should vaccination with the Pfizer-BioNTech COVID-19 vaccine be recommended for people 16 years of age and older?
According to Dr. Matthew Daley, ACIP COVID-19 Vaccines Work Group chair, "when considering recommending a licensed vaccine for use, never before has the ACIP made such recommendations with such a breadth and depth of information..." The recommendation Monday stemmed from updated clinical trial data and further follow-up on safety, beyond the data under review last December under emergency approval.
Panel members said the vaccine remains available to adolescents 12-15 under emergency approval, as well as third doses among immunocompromised patients.
As of Aug. 18, the panel reported 327 confirmed myocarditis cases through VAERS, a national surveillance system, against a backdrop of 17 million second doses of Pfizer vaccine administered among people 16-29. Males aged 16-17 saw the highest reporting rates at about 72 cases of myopericarditis per million second doses administered. Of 845 cases among people under 30, at least 77% recovered from symptoms.
However, COVID-19 patients face an estimated 6-34 times greater risk of heart inflammation following infection, compared to those who received mRNA vaccines, according to slides presented during the meeting.