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Medical Professionals Reference (MPR)FDA Greenlights Updated COVID-19 Vaccines; Bivalent Vaccines No Longer Authorized

New Formulations Target XBB.1.5 Sublineage to Combat Current Variants

The FDA has given the green light to updated versions of the Pfizer-BioNTech and Moderna COVID-19 vaccines, which now include spike proteins targeting the XBB.1.5 sublineage of SARS-CoV-2. This move aims to bolster immunity against the currently circulating variants and marks the end of the authorization for the original bivalent vaccines in the United States.

HCN Medical Memo
This FDA approval signifies a critical update in our arsenal against COVID-19. The new formulations are designed to be more effective against current variants, offering an additional layer of protection for both adults and children. It is crucial to stay updated on the CDC’s forthcoming recommendations and to encourage eligible patients to get vaccinated with the updated versions.

Key Points
  • The FDA’s approval is based on studies showing that the updated vaccines elicit immune responses similar to those triggered by previous versions against corresponding older variants.
  • The updated vaccines are approved for individuals aged 12 and older and are authorized for emergency use in children aged 6 months to 11 years.
  • A single dose of the updated mRNA vaccine is recommended for individuals 5 years and older who have been previously vaccinated, at least two months after their last COVID-19 vaccine dose.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19.”
– Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research

Additional Points
  • Children under 5 who have been vaccinated previously can receive 1 to 2 doses of this season’s vaccine, depending on the type of previous COVID-19 vaccine received.
  • The CDC’s Advisory Committee on Immunization Practices will meet on September 12th to discuss further recommendations on the updated vaccines.
  • The updated vaccines are expected to be available in the coming days.

More on Vaccines

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