CDC panel recommends Pfizer/BioNTech COVID-19 vaccine under full FDA approval

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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.

La votación fue 14-0.

The recommendation will now go before CDC Director Dr. Rochelle Walensky. 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?

Según el 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.

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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, por lo menos 77% recovered from symptoms.

sin embargo, 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.

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