FDA cancels authorization of original vaccines against covid in the United States

The governing agency for food and drug use in the United States, named the Food and Drug Administration (FDA), annulled the authorization allowing the use of the old monovalent vaccines against covid-19 from the Pfizer/BioNTech and the Modern in the country, which had been applied since December 2021. Now only the use of bivalent vaccines from the same agents will be allowed.

The information was released by the FDA, this Tuesday (18), “This action includes authorizing the use of current bivalent vaccines (original strains and Omicron BA.4/BA.5) for all doses administered to individuals from 6 months of age, including for additional dose or doses for certain populations. Moderna’s and Pfizer-BioNTech’s monovalent COVID-19 vaccines are no longer authorized for use in the United States.” declared in a note. The government recommended boosting bivalent vaccines to the entire population that has already taken doses of the monovalent vaccine.

The resolution was given in order to facilitate the vaccination method, since, according to the laboratories, two initial doses of bivalents from Pfizer/BioNTech and Moderna can be used as the main method of immunization. The discontinuity of the old dose does not owe the efficacy or safety to monovalent vaccines. The responsible bodies already succeeded the new dose, but before it was used only as a booster.

Elderly and immunocompromised people (people with immune-mediated inflammatory diseases) may receive a second dose of the bivalent vaccine, which will serve as a booster. This second dose should be applied within two months after the first dose of the vaccine.

Differences between monovalent and bivalent vaccines

The monovalent vaccines were produced against the covid-19 virus, they are the beginning of the vaccination scheme, that is, the first two doses of the vaccine, with the application of the booster, occur during the monovalent vaccination.

Bivalent vaccines, also against covid-19, bring in their formulation the original strain and the omicron BA.4/BA.5 variant.

Featured photo: Covid-19 vaccine/Agência Brasil/Reproduction