by Dwight Marquez || Photo Credit: Johns Hopkins: Bloomberg School of Public Health

Anticipating an uptick in COVID-19 cases, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations of the Pfizer-BioNTech and Moderna COVID-19 Vaccines to allow the use of newly reformulated vaccines as single-use booster shots.

The updated COVID-19 booster is a bivalent vaccine developed to specifically target both the original COVID-19 strain and the recently circulating Omicron subvariants BA.4 and BA.5.

On September 2, the Philippines logged 656 new cases of the Omicron subvariants. Of this number, 624 were cases of the Omicron BA.5 subvariant, 13 cases of BA.4, 1 case of BA.2.12.1, and 18 cases tagged as “other sublineages.”

Booster shots are an essential line of defense against the COVID-19 virus as vaccines become less effective when it mutates.

“They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants,” said Center for Disease Control and Prevention (CDC) Director Rochelle P. Walensky in a statement after briefing the public of the boosters’ use.

Data from clinical (human) studies with similar BA.1 bivalent boosters and nonclinical trials with BA.4/BA.5 bivalent vaccines have shown increased immune response against Omicron subvariants, while also demonstrating a “non-inferior” antibody response against the ancestral strain. The shots prompted reactions similar to the primary doses and have remained safe.

Pfizer Incorporated’s Vice President, Kena Swanson, suggested during a vaccine advisory committee meeting that preclinical data have “reliably predicted” the clinical results of variant-modified vaccines.

The U.S. FDA authorized the use of Pfizer-BioNTech bivalent boosters for anyone age 12 and older, while Moderna’s bivalent vaccines for adults 18 and older. Both shots require the completion of the primary doses and a 2-month interval following a primary or booster vaccination. The same eligibility criteria were recommended by the CDC.

The Marcos administration promised to look into the updated bivalent boosters and provide the shots to those who need them.