FDA: Monovalent Pfizer and Moderna COVID-19 Vaccines Are No Longer Authorized, New Protocols Announced

 In a press release on Tuesday, the FDA has declared the monovalent Pfizer and Modena mRNA Covid-19 vaccines are no “longer authorized for use in the United States.”

The decision was made through a recent amendment to the Emergency Use Authorizations of the Moderna and Pfizer Covid-19 bivalent vaccines.

In the amendment, the FDA ruled the bivalent Moderna and Pfizer Covid-19 vaccines will be used for all doses and monovalent doses (targeted original strain) will no longer be authorized.

The FDA claims the decision was made in order to simplify the vaccine process, but many people who have already received the monovalent Covid-19 vaccine are questioning why the FDA is making the decision now.

Today, FDA amended the EUAs of the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. https://t.co/Cd74KB3n9p
What you need to know. 🧵👇 pic.twitter.com/9394LP1HvR

— U.S. FDA (@US_FDA) April 18, 2023

Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.

— U.S. FDA (@US_FDA) April 18, 2023

Per The FDA:

Today, the 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.

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.

Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.

Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.

The sudden decision caught the attention of James O’Keefe who is now asking FDA whistleblowers to come forward.

Can someone from the FDA please tell me what’s going on here? OKeefeTips@protonmail.com https://t.co/YfyLeJyWNn

— James O'Keefe (@JamesOKeefeIII) April 18, 2023