Moderna requests FDA authorization for updated COVID shot

Moderna announced Thursday it has submitted an application to the Food and Drug Administration (FDA) for authorization of its updated COVID-19 vaccine for this year’s inoculation campaign, meant to target the current dominant strain in the U.S.

This latest version of the coronavirus vaccine, the second update to the original that was first authorized at the end of 2020, will have proteins designed to confer protection against the XBB.1.5 subvariant. Unlike the bivalent vaccine that was made available last year, this shot does not include protection against the ancestral Wuhan strain.

Last week, the FDA told vaccine manufacturers that their coronavirus vaccines for this fall should target XBB.1.5, which accounts for about 40 percent of cases in the U.S., though this number is declining.

“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.

Moderna said in its announcement that the reported side effects of this vaccine included injection site pain, headache, fatigue, muscle pain and chills.

Authorities are preparing for a fall vaccine campaign against COVID-19 this year, akin to how annual flu vaccines are administered. While a strain has been selected, getting people to get the shot will be the primary challenge for health officials.

Only 17 percent of the U.S. has received the updated bivalent shot since it was made available last year. The bivalent shot provided protection against the ancestral strain as well as the BA.4 and BA.5 omicron subvariants. Protection has been observed to wain over time and experts are concerned that immunity against SARS-CoV-2 may not be strong enough this winter without updated immunizations.