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September 1, 2022

FDA grants EUAs for Moderna and Pfizer-BioNTech’s bivalent Covid-19 boosters

The EUA amendments are based on the totality of available data from clinical trials and nonclinical findings.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer-BioNTech’s Covid-19 vaccines as boosters.

According to the amended EUA, the vaccines are indicated to be administered at a minimum of two months after the initial or booster dose. 

These ‘updated boosters’ comprise the SARS-CoV-2 virus’ two messenger RNA (mRNA) components, one from the initial strain and the other one common between the BA.4 and BA.5 lineage of the Omicron variant. 

Moderna’s bivalent vaccine is intended to be administered as a single booster dose in people aged 18 years and above. 

Pfizer-BioNTech’s bivalent shot is authorised for usage as a single booster dose in people aged 12 years and above. 

Since December 2020, the companies’ monovalent Covid-19 vaccines with a component from the initial virus strain have received authorisations or approvals from the regulatory agency.

The EUA amendments by the FDA are based on the totality of available data. 

It comprised broad safety and effectiveness data for the respective monovalent mRNA Covid-19 vaccines of the companies, as well as safety and immunogenicity findings from a trial of a bivalent Covid-19 vaccine with mRNA from omicron variant BA.1 lineage.

Nonclinical data obtained using bivalent Covid-19 vaccines were included in the dataset.

According to these findings, the bivalent vaccines are anticipated to offer enhanced protection against the Omicron variant circulating presently. 

With the latest development, the monovalent mRNA Covid-19 vaccines are no longer indicated for use as a booster for people aged 12 years and above.

FDA commissioner Robert Califf said: “The Covid-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalisation and death) of Covid-19. 

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone eligible to consider receiving a booster dose with a bivalent Covid-19 vaccine to provide better protection against currently circulating variants.”

In August, Moderna sought FDA EUA for the BA.4/BA.5 Omicron-targeting bivalent booster vaccine for Covid-19, mRNA-1273.222.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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