Emergency Use of Moderna and Pfizer’s COVID-19 Booster Vaccine Approved by FDA

New booster COVID-19 vaccine candidate effective against Omicron subvariants, Moderna says

Emergency Use of Moderna and Pfizer’s COVID-19 Booster Vaccine Approved by FDA

Emergency Use of Moderna and Pfizer’s COVID-19 Booster Vaccine Approved by FDA:  The Food and Drugs Administration agency of the United States has issued an emergency use authorisation for the updated versions of the Moderna and Pfizer-BioNTech COVID-19 Vaccine booster shots.

The FDA said the updated Moderna COVID-19 Vaccine is approved for use as a single booster dose in individuals who are 18 years of age and older, while the Pfizer COVID-19 Vaccine is authorised for those who are 12 years and up. 

The regulatory agency disclosed this on Wednesday, in a statement made available on its official website.

The bivalent vaccines also referred to as ‘updated boosters,’ the FDA said, contains a component from the original strain of SARS-CoV-2 after the agency’s Vaccines and Related Biological Products Advisory Committee voted to include it in June.

It also stated that it should be given at least two months after primary vaccination or the original boosters.

The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks said in the news release, “The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants.

“We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19.

“We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently and we are confident in the evidence supporting these authorizations,” he said.

Based on the data backing up each of the authorisations, the bivalent COVID-19 vaccines are anticipated to provide improved protection against the currently circulating omicron variant.

The FDA Commissioner Dr. Robert Califf further urged individuals to get the new booster shots.

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

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalisation and death) of COVID-19,” he said.

 

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