A vial and a medical syringe seen in front of the logos of the U.S. Food and Drug Administration and biotech company Moderna.
Pawel Gonczar | LightRocket | Getty Images
Modern Thursday applied for approval by the U.S. Food and Drug Administration of the biotech company’s updated fall Covid vaccine.
The target of the shot is the omicron XBB.1.5 subvariant, the dominant strain of the virus across the country.
Moderna said the filing is based on last week’s FDA recommendation that vaccine manufacturers update their vaccines to target XBB.1.5, which is one of the most immune-evasive Covid strains to date.
Modern and rivals Pfizer Novavax has already started developing XBB-targeted versions of its vaccines 1.5 months ahead of the FDA’s recommendation.
All three companies are expected to make the vaccines available to Americans in the fall, pending FDA approval.
“The agility of our mRNA platform has allowed us to update Moderna’s Spikevax, a COVID-19 vaccine, to target XBB variants with speed and clinical rigor,” Moderna CEO Stéphane Bancel said in a statement.
The FDA will review available data on the effectiveness and safety of the Moderna vaccine to decide whether to approve it in the fall.
Data from preclinical studies in mice suggest that the monovalent vaccine targeting XBB.1.5 produces a stronger immune response against the currently circulating XBB variants than the company-authorized bivalent vaccine targeting the BA.4 and BA.5 strains, as presented by Moderna last week.
Data from clinical trials in over 100 subjects similarly show that the XBB.1.5 monovalent 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 move Covid vaccine distribution to the private sector as early as fall. This means Moderna, Pfizer and Novavax will sell their updated vaccines directly to healthcare providers, not the government.
It is not known how many people will take new photos.
According to data from the Centers for Disease Control and Prevention, only about 17% of the US population has received the latest boosters from Pfizer and Moderna since they were approved in September.