Excerpted from Children's Health Defense.
As Omicron Surges, FDA’s Vaccine Strategy Called Into Question
Madhava Setty, MD
The Omicron variant is the predominant COVID-19 strain in the U.S., prompting a pause in the distribution of certain ineffective monoclonal antibody therapies. Yet the push for vaccines, also ineffective against the variant, continues unabated.
The first case of Omicron in the U.S. was reported on Dec. 1, 2021. As of Dec. 25, 2021, the Centers for Disease Control and Prevention (CDC) estimates Omicron accounts for 58.6% of SARS-CoV-2 infections in the U.S.
Omicron’s rapid emergence is indicative of the variant’s increased transmissibility and the lack of efficacy vaccines have against this strain.
The predominance of the Omicron variant prompted the Office for the Assistant Secretary of the U.S. Department of Health and Human Services (HHS) to pause allocation of two commonly used monoclonal Antibody therapy combinations — bamlanivimab/etesevimab (Eli Lilly) and REGN10933/REGN10987 (Regeneron) — to regions of the country that have greater than 80% prevalence of the Omicron variant.
According to HHS, “These two products are not expected to be effective in patients infected with the Omicron variant…”