COVID-19 Vaccine for Individuals who Received Primary Vaccination Not Approved/Authorized in the US
Updated Information from CDC on COVID-19 Vaccine for Individuals who Received Primary Vaccination Not Approved/Authorized in the US
The CDC recently updated the Emergency Use Instructions (EUI) and clinical guidance for persons who received primary vaccination with vaccines not approved/authorized in the U.S. The updated EUI and clinical guidance state that individuals who received an incomplete series of a vaccine listed for emergency use by the WHO but not authorized nor approved by the FDA no longer need to restart the primary COVID-19 vaccine series in the U.S. Instead, these individuals may now receive a single dose of Pfizer-BioNTech COVID-19 vaccine at least 28 days after receipt of their most recent dose, after which they will be considered fully vaccinated.
FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age – December 9, 2022 Dear COVID-19 Vaccination Provider: On December 8, 2022, FDA authorized the bivalent Moderna COVID-19 vaccine for children ages 6 months through 5 years of age and bivalent Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 […]
Yesterday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines. CDC’s Director Dr. Rochelle Walensky released a statement and signed a decision memo recommending updated (bivalent) COVID-19 boosters for children five years and older. This expands on CDC's recommendation issued September 1, 2022, for updated COVID-19 boosters of people ages 12 and older.
Updated Clinical Guidance For Individuals 6 Months-11 Years Old – June 22, 2022 Dear NYS COVID-19 Vaccine Provider: Effective June 18, 2022, the CDC has recommended that everyone ages 6 months and older in the United States should receive a COVID-19 primary series vaccination for the prevention of COVID-19. This attached provider guidance has […]
Updated Guidance for The New York State COVID-19 Vaccination Program for Individuals 12 Years of Age or Older June 13, 2022 Note: This guidance document applies specifically to health care providers offering COVID-19 vaccinations to adolescents and adults ages 12 and older. Guidance specific to COVID-19 vaccination of children ages 5-11 can be found […]