U.S. Purchases 600,000 Monoclonal Antibody Treatments

London-based GSK and Vir Biotechnology, Inc. today announced that the U.S. Government would purchase in the first quarter of 2022 an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody (mAbs) for the early treatment of COVID-19.

Including the U.S. government's commitments announced on January 11, 2022, GSK and Vir have received binding agreements to sell approximately 1.7 million doses of sotrovimab worldwide.

The companies are forecasting manufacturing approximately 2 million sotrovimab doses globally in the first half of 2022.

However, data for GSK and Vir indicate this mAbs will remain in limited supply.

As of January 10, 2022, the U.S. government only distributed 52,128​ Sotrovimab treatments throughout the U.S.

And in total, the U.S government distributed 726,876 mAbs and antiviral treatments this week.

Sotrovimab, which the U.S. FDA granted Emergency Use Authorization in May 2021, is an investigational single-dose intravenous (IV) infusion SARS-CoV-2 mAbs to treat mild-to-moderate COVID-19 in certain adults and pediatric patients.

George Scangos, Ph.D., CEO of Vir, said in a related press statement, "As the Omicron variant continues its rapid spread alongside the still prevalent Delta variant, we are pleased to once again work with the U.S. government to provide more access to sotrovimab for people in the U.S. at high risk of progression to severe COVID-19."

"Data from multiple pseudo-virus and live virus preclinical studies, generated by industry and academia, continue to demonstrate that sotrovimab retains activity against all tested variants of concern and interest."

"We are proud of our ongoing contributions to the fight against the COVID-19 pandemic here in the U.S. and around the world."

GSK and Vir confirmed preclinical pseudo-virus data demonstrate that sotrovimab retains activity against all tested variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organization, including, but not limited to, Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).

Preclinical live virus testing has also been completed, with data further demonstrating that sotrovimab retains activity against the Omicron variant.

Sotrovimab is an investigational SARS-CoV-2 neutralizing mAbs. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, making it more challenging to resist resistance develop. 

The U.S. NIH's OpenData Portal publishes real-time information regarding mAbs effectiveness against the Omicron virus variant.