GSK and Vir’s COVID-19 therapy unlikely to work against new BA.2 variant

The FDA revoked the therapy's approval across much of the north-eastern U.S., where the subvariant is prominent.

The current allowed dose of GlaxoSmithKline (GSK) and Vir Biotechnology's COVID-19 antibody treatment is unlikely to be effective against the Omicron BA.2 variant, according to the U.S. Food and Drug Administration (FDA). In parts of the U.S. northeast, where the subvariant is dominant, the agency revoked approval for the therapy, sotrovimab. According to government data released earlier this week, the highly contagious BA.2 variant now causes nearly one-third of COVID-19 infections in the United States. GSK and Vir announced on Friday that they are putting together a bundle of data to support a higher dose of sotrovimab for the BA.2 variant than the presently approved 500 mg. The data will be shared with regulatory authorities around the world for discussion.

The FDA's decision is a setback for companies who have witnessed a surge in demand for sotrovimab after it was discovered to be one of the few COVID-19 therapies that has been proved to function against the Omicron variant. GSK and Vir claim that the therapy still has neutralizing effect against the BA.2 sub-variant, but others, including Columbia University experts, disagree. The FDA also said on Friday that Eli Lilly's newly approved antibody therapy bebtelovimab, as well as Merck and Pfizer's antiviral tablets and Gilead Sciences Inc's remdesivir, are predicted to be effective against the BA.2. The BA.2 variant is already circulating with a frequency surpassing 50% in many parts of the U.S., according to the Centers for Disease Control and Prevention (CDC).