The December 13th edition of the Centers of Disease Control and Prevention (CDC) Morbidity and Mortality Report (MMWR) includes interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged 16 years and older for the prevention of COVID-19. The recommendations follow the U.S. Food and Drug Administration’s recent “Emergency Use Authorization” (EUA) of the much-anticipated vaccine.
Developed by the CDC’s Advisory Committee on Immunization Practices (ACIP), the interim recommendations were released on Sunday, in concert with the start of nationwide distribution of millions of doses of the new vaccine.
Read the full MMWR Report, which includes highlights from the decisive clinical trial, interim findings from which showed that the Pfizer-BioNTech COVID-19 vaccine was “95.0% effective in preventing symptomatic laboratory-confirmed COVID-19 in persons without evidence of previous SARS-CoV-2 infection.” The report also indicates that the vaccine may be administered to individuals with underlying medical conditions who have no contraindications to vaccination. Further, phase 2/3 trials demonstrated similar safety and efficacy profiles in persons with underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to persons without comorbidities.
The ACIP recommendations also include an algorithm – encompassing important factors such as certain health conditions and allergies – designed to help inform decisions and follow up actions relevant to potential vaccine recipients.
Important notes and resources:
- The FDA’s EUA fact sheet should be provided to recipients and caregivers before vaccination
- Adverse events that occur in a recipient after receiving the vaccine should be reported. Access this link for instructions on how to make a report to the Vaccine Adverse Events Reporting System (VAERS) or call 1.800.822.7967
- Engaging in Effective COVID-19 Vaccine Conversations
- These interim recommendations developed in light of the EUA will be updated as additional information becomes be available.
