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Hello,
As we embark on the biggest mass vaccination campaign of our time, we at AIRA are committed to sharing important decisions and recommendations with you as soon possible. As you know, yesterday the U.S. Food and Drug Administration (FDA) approved the country’s first COVID-19 vaccine. The Advisory Committee on Immunization Practices (ACIP) met on Friday, December 11 and Saturday, December 12. At the December 12 meeting, the ACIP discussed and voted on recommendations for the Pfizer-BioNTech COVID-19 vaccine. The ACIP members received an update on the safety and efficacy data for the Pfizer-BioNTech COVID-19 vaccine. The members then used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to develop recommendations.
Recommendations
The members voted that “The Pfizer-BioNTech COVID-19 vaccine is recommended for persons 16 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization.”
The members also voted to amend the 2021 immunization schedules for adults and children/adolescents to include the following language about COVID-19 vaccine: “ACIP recommends use of COVID-19 vaccines within the scope of the Emergency Use Authorization or Biologics License Application for the particular vaccine. Interim ACIP recommendations for the use of COVID-19 vaccines can be found at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html.”
The recommendation should be implemented in the context of current CDC allocation recommendations.
Impact on IIS
The Clinical Decision Support for Immunization (CDSi) rules are currently being developed and reviewed. The draft version will be released soon, and the official version will become available shortly after publication of the Morbidity and Mortality Weekly Report.
The next scheduled ACIP meetings are on December 18 from noon to 6 p.m. ET and December 20 from noon to 6 p.m. ET. Meeting dates and times are based on FDA meetings and vaccine emergency use approval and are subject to change.
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