FDA says GSK-Vir COVID Antibody Unlikely to Work Against BA.2 Variant

The US health regulator, FDA has said that the currently authorised dose of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapy is unlikely to be effective against the Omicron BA.2 variant.

The agency has withdrawn approval for sotrovimab therapy in many of the northeastern United States, where subvariants are dominant. Highly contagious BA.2 currently causes about one-third of cases of COVID-19 in the United States, according to government data earlier this week. 

GSK and Vir said that they are preparing a package of data in support of a higher dose for sotrovimab than the currently authorised 500 mg, for the BA.2 subvariant. The data will be shared with regulatory authorities around the world for discussion.

The FDA's move as a blow to the companies, which saw high for sotrovimab after it has become one of the few COVID 19 treatments that have shown to be effective against the Omicron variant. 

The US Centers for Disease Control and Prevention (CDC) has determined that the BA.2 variants are currently over 50% in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Puerto Rico and the Virgin Islands.

The FDA also said that Eli Lilly’s newly authorised antibody therapy bebtelovimab is expected to be effective against the BA.2, along with Merck and Pfizer antiviral pills and Gilead Sciences Inc’s remdesivir.

The Office of the Assistant Secretary for Preparedness and Responses has said that it would pause the distribution of sotrovimab to these states. However, sotrovimab is still available in all other US regions until further notice by FDA.