Moderna’s bivalent booster awaits emergency use authorization

The U.S. Food and Drug Administration (FDA) has received Moderna’s application for emergency use authorization for its bivalent booster vaccine, mRNA-1273.222, which targets the BA.4/BA.5 Omicron, the company said in a press release.

Based on preclinical and clinical trial results available for the Moderna bivalent booster candidate, the application is for a 50 µg booster dose for people 18 years of age and older.

“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“Moderna’s mRNA platform has enabled us to develop, study, and deploy bivalent booster vaccine candidates that demonstrate superior protection against all tested COVID variants, in record time. Our commitment to using cutting-edge science to protect the world against the ongoing COVID threat continues.”

While Moderna requested approval for usage among those 18 and older, Pfizer’s application is for emergency use among those 12 years of age and older, Reuters reports.

After receiving regulatory approval, the doses will be prepared for shipping, according to Pfizer. Moderna has also increased the production of the BA.4 and BA.5 targeted vaccine so that it will be available for delivery by the end of the month.

In comparison to the booster shot against the original coronavirus strain, Moderna’s two booster vaccines against the BA.1, BA.4, and BA.5 subvariants showed substantial neutralizing activity in human and pre-clinical studies, as Bio.News previously reported.

Earlier this week, Pfizer and BioNTech, manufacturers of another key mRNA COVID-19 vaccine, requested federal authorization of their bivalent booster vaccine targeting Omicron variants.

As Bio.News previously reported, the FDA and Biden administration have called for a fall booster vaccine program that specifically targets COVID-19 variants, including the Omicron variants.

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