Updated FDA Authorization, COVID-19 Vaccines
On April 18th, U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. See https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines
This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. This means you should not administer any monovalent mRNA (Pfizer or Moderna) to any age group beginning today (April 19th).
- EUA Fact Sheets have been consolidated to include all age groups and there is now one EUA Fact Sheet for Healthcare Providers and one for Recipients and Caregivers. The website www.cvdvaccine-us.com is in the process of being updated, so for now, the new fact sheets are available on the FDA website at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines
- Pfizer Medical Affairs will be conducting LIVE Webinars for all healthcare providers beginning on April 19, 2023 for several weeks before transitioning to ON DEMAND content. The full live training schedule is available at https://www.pfizermedicalinformation.com/en-us/medical-updates. The links for this week's sessions are provided below: