Moderna files for FDA approval of updated Covid vaccine for fall

Moderna on Thursday applied for U.S. Food and Drug Administration approval of the biotech company’s updated Covid vaccine for the autumn. 

The shot targets omicron subvariant XBB.1.5, the dominant strain of the virus nationwide. 

Moderna said the submission is predicated on the FDA’s advice last week that vaccine makers update their jabs to focus on XBB.1.5, which is some of the immune-evasive Covid strains thus far. 

Moderna and rivals Pfizer and Novavax already began to develop versions of their vaccines targeting XBB.1.5 months before the FDA’s advice.

All three corporations are expected to make vaccines available to Americans in time for the autumn, pending the FDA’s approval.

“The agility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to focus on XBB variants with speed and clinical rigor,” Moderna CEO Stéphane Bancel said in an announcement. 

The FDA will review Moderna’s available efficacy and safety data on the shot to make your mind up whether to approve it for the autumn. 

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 corporate’s authorized bivalent shot targeting the BA.4 and BA.5 strains, in line with a Moderna presentation last week. 

Clinical trial data on greater than 100 people similarly demonstrates the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received 4 Covid vaccine doses.

The U.S. is predicted to shift Covid vaccine distribution to the private sector as soon as the autumn. Which means Moderna, Pfizer and Novavax will sell their updated jabs on to health care providers fairly than to the federal government.

It’s unclear how many individuals will take the brand new shots.

Only about 17% of the U.S. population has received Pfizer and Moderna’s latest boosters since they were approved in September, in line with data from the Centers for Disease Control and Prevention.