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Medical vial and syringe displayed in front of the US Food and Drug Administration and Moderna Biotechnology logos.
Buffalo Jonchar | Light Rocket | Getty Images
accident Thursday applied To seek FDA approval for the biotech company’s updated Covid vaccine for the fall.
The shot targets the XBB.1.5 variant of Omicron, the dominant strain of the virus across the country.
Moderna said the submission builds on a recommendation by the US Food and Drug Administration last week that vaccine makers update their hits to target XBB.1.5, which is one of the most immuno-elusive Covid strains yet.
Moderna and its competitors Faizp and novafax They actually started developing versions of their vaccines that target XBB 1.5 months earlier than the FDA recommendation.
The three companies are expected to make the vaccines available to Americans in time for the fall, pending approval from the Food and Drug Administration.
“The flexibility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants with clinical speed and accuracy,” Moderna CEO Stéphane Bancel said in a statement.
The FDA will review the efficacy and safety data available on Moderna’s shot to decide whether to approve it in the fall.
Preclinical trial data in mice suggests that a monovalent vaccine targeting XBB.1.5 produces a stronger immune response against currently circulating XBB variants than the company’s licensed bivalent shot targeting the BA.4 and BA.5 strains, according to a Moderna presentation last week.
Clinical trial data in more than 100 subjects similarly shows that monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All of the trial participants had previously received four doses of the Covid vaccine.
The US is expected to shift distribution of the Covid vaccine to the private sector as soon as fall. This means that Moderna, Pfizer, and Novavax will sell their updated products directly to healthcare providers rather than to the government.
It’s unclear how many people will take the new shots.
Only 17% of the US population has had Pfizer and Moderna’s latest boosters since they were approved in September, according to data from the Centers for Disease Control and Prevention.
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