Moderna Files for FDA Authorization for This Year’s COVID-19 Vaccine

Last week, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss the formulation for the upcoming seasonal respiratory season and the COVID-19 vaccine composition.

The committee voted yes to recommend the vaccines be monovalent and contain the XBB lineage. With this, COVID-19 vaccines are moving away from the Wuhan (Wild strain). Data reported during the meeting showed that XBB sublineages account for more than 95% of the world’s circulating COVID-19 variants today.

With this understanding, vaccine manufacturers are able to update their products to reflect the VRBPAC recommendation.

Late yesterday, Moderna announced it had filed for FDA authorization of their updated COVID-19 vaccine, mRNA-1273.815, which contains spike proteins for the XBB15 sublineage of SARS-CoV-2.

At the VRBPAC meeting last week, Moderna was the only company to submit preliminary clinical data comparing monovalent and bivalent vaccines and showing robust human immune responses across multiple XBB descendent sublineages such as XBB15, XBB.116 and XBB232.

“Our preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants of concern," Moderna CEO Stéphane Bancel, said in a statement. 

Pending FDA authorization of the vaccine, the company has said the vaccines would be available in time for fall vaccination.

Moderna reiterated its platform allows the company to pivot and change the composition of the vaccine based off the latest data and the variants that are circulating.

"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," Bancel said.