FDA: Monovalent mRNA vaccines no longer authorised in US, bivalent only

On April 18, 2023 the FDA announced [1] it amended the emergency use authorizations (EUAs) so that “monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States“, only the bivalent (original and omicron BA.4/BA.5 strains) vaccines will be authorised, so as “to simplify the vaccination schedule for most individuals”. [2]

The bivalent products were never authorized for primary dose, especially not to new borns and babies, they were only considered as boosters, and on the back of 8 mice.

Without any clinical trials for safety or efficacy, the FDA has approved the bivalent vaccine for unvaccinated adults, whom were never part of the bivalent “trials” – they’ve already adopted the “flu vaccine” model. [3]