New findings by Gilead Sciences suggest that Velkury's antiviral COVID 19 treatment will continue to be active against the new omicron variant.
After doing an initial genetic analysis of more than 200 available sequences of the omicron variant, the biotechnology giant has found no new mutations present in the strain, which is expected to alter the viral RNA polymerase compared to previous COVID 19 variants. Remdesivir targets the viral RNA polymerase in order to prevent replication of SARS-CoV-2 inside infected cells.
Gilead continues to evaluate remdesivir through in vitro antiviral testing.
Gilead said in a statement Wednesday that Veklury's antiviral activity has been confirmed in vitro against all major previously identified variants of SARS-CoV-2 including Alpha, Beta, Gamma, Delta and Epsilon. Due to the similarities in the viral RNA polymerase, these laboratory findings suggest that Veklury will continue to be active against the Omicron variant and Gilead will conduct laboratory testing to confirm this analysis. The company is working with government and academic experts to obtain viral isolates and conduct in vitro lab testing of the remdesivir's antiviral activity against omicron, and will share the data with regulators, physicians and public health authorities when testing is completed.
No major genetic changes have been identified in any of the known COVID 19 variants of concern and variants of interest that would significantly alter the viral RNA polymerase targeted by remdesivir, but all identified variants have mutations at different locations in the SARS-CoV- 2 spike protein, the target for all neutralizing antibodies.
Remdesivir, which is authorized for temporary use in approximately 50 countries worldwide, has been made available to 9 million patients, including 6.5 million people in 127 middle and low-income countries.
In addition to Gilead, Pfizer and BioNTech, Moderna and Johnson Johnson are all evaluating the effectiveness of their current vaccines against omicron. Both Moderna and Johnson Johnson are developing omicron-specific booster shots of their vaccine, while Pfizer has started its own neutralization tests on the strain.
A Pfizer and BioNTech spokeswoman told FOX Business that if a variant emerges that it escapes protection, Pfizer and BioNTech expect to be able to develop and produce a tailor-made vaccine against that variant in approximately 100 days.
Pfizer has an emergency use authorization for its antiviral COVID 19 pill Paxlovid, which showed nearly a 90% reduction in hospitalization and death in a recent study. The spokesperson said Pfizer expects Paxlovid to be effective against the omicron variant, and that it will manufacture 80 million courses of the pill, up from its original goal of 50 million. The Biden administration has already reached a $5.29 billion agreement last month.
Gilead's announcement came as the first case of the omicron COVID 19 variant was discovered Wednesday in California.
The Centers for Disease Control and Prevention said the impacted individual was a traveler who returned from South Africa on November 22. The person who was fully vaccinated and had mild symptoms that are improving is self-quarantining. All close contacts have been contacted and have tested negative.
The agency recommends that all Americans aged 5 and older get vaccine booster shots, and all Americans ages 18 and older get vaccine booster shots.