Moderna on Thursday applied for U.S. Food and Drug Administration approval of the biotech company’s updated Covid vaccine for the fall.
The shot targets omicron subvariant XBB.1.5, the dominant strain of the virus nationwide.
Moderna said the submission is based on the FDA’s recommendation last week that vaccine makers update their jabs to target XBB.1.5, which is one of the most immune-evasive Covid strains to date.
Moderna and rivals Pfizer and Novavax already began to develop versions of their vaccines targeting XBB.1.5 months before the FDA’s recommendation.
All three companies are expected to make vaccines available to Americans in time for the fall, pending the FDA’s approval.
“The agility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants with speed and clinical rigor,” Moderna CEO Stéphane Bancel said in a statement.
The FDA will review Moderna’s available efficacy and safety data on the shot to decide whether to approve it for the fall.
Preclinical trial data on mice suggests a monovalent vaccine targeting XBB.1.5 produces a more robust immune response against the currently circulating XBB variants than the company’s authorized bivalent shot targeting the BA.4 and BA.5 strains, according to a Moderna presentation last week.
Clinical trial data on more than 100 people similarly demonstrates the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses.
The U.S. is expected to shift Covid vaccine distribution to the private sector as soon as the fall. That means Moderna, Pfizer and Novavax will sell their updated jabs directly to health care providers rather than to the government.
It’s unclear how many people will take the new shots.
Only about 17% of the U.S. population has received Pfizer and Moderna’s latest boosters since they were approved in September, according to data from the Centers for Disease Control and Prevention.