Moderna Seeks FDA Approval of Up to date Covid Vaccine for Fall

A vial and medical syringe in front of the logos of the US Food and Drug Administration and biotechnology company Moderna.

Pavlo Gonchar | Light Rocket | Getty Images

Modern On Thursday, the U.S. Food and Drug Administration filed for approval of the biotech company’s updated Covid vaccine for the fall.

The shot is aimed at the Omicron subvariant XBB.1.5, the country’s dominant virus strain.

Moderna said the filing follows last week’s FDA recommendation that vaccine makers should switch their vaccinations to XBB.1.5, one of the most immune-evading Covid strains to date.

Moderna and rivals Pfizearound Novavax started developing versions of their vaccines against XBB 1.5 months before the FDA recommendation.

All three companies are expected to have vaccines available to Americans in time for the fall, pending FDA approval.

“The agility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants quickly and with clinical precision,” Moderna CEO Stéphane Bancel said in a statement.

The FDA will review Moderna’s available efficacy and safety data on the vaccine to decide whether to approve it for the fall.

Preclinical trial data in mice suggest that a monovalent vaccine targeting XBB.1.5 elicited a more robust immune response against currently circulating XBB variants than the company’s approved bivalent vaccine targeting strains BA.4 and BA.5 is aimed at, according to a presentation by Moderna last week.

Clinical trial data in more than 100 people also show that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All study participants had previously received four doses of the Covid vaccine.

The US is expected to shift Covid vaccine distribution to the private sector as early as the fall. That means Moderna, Pfizer, and Novavax will sell their updated vaccines directly to healthcare providers, not the government.

It’s unclear how many people will take the new vaccines.

Only about 17% of the US population has received the latest booster shots from Pfizer and Moderna since their approval in September, according to data from the Centers for Disease Control and Prevention.