The “combined frequency” of the P.1 variant (first identified in Brazil) and the B.1.351 variant (first identified in South Africa) now exceeds 10% in Arizona, California, Florida, Indiana, Oregon and Washington; in Illinois and Massachusetts, the P.1 variant has been “consistently bred to more than 10% frequency,” the ad says.
The discontinuation is not related to the safety of the cocktail – in which the drugs bamlanivimab and etesevimab are given together – but rather concerns the fact that it is not as effective against these variant strains. The break will not impact distribution in other parts of the country, according to the bulletin.
The treatment received emergency use authorization from the Food and Drug Administration in February. Monoclonal antibody treatments like these are intended for use in the early stages of COVID-19 infection for outpatients who are at high risk of progressing to serious illness, in order to prevent them from developing enter the hospital. It should be administered within days of diagnosis.
For now, the FDA recommends that healthcare providers in those states instead use the Regeneron monoclonal cocktail approved for patients with COVID-19.
So far, clinical trial data has shown that Regeneron’s cocktail is slightly more effective against current major variants than that of Lilly, which in its own laboratory studies has shown decreased efficacy among all variants, except variant B.1.1.7, or UK variant.
In a statement to ABC News, Lilly said she is “constantly monitoring the COVID-19 environment, evaluating the neutralization of our antibody therapies against a wide range of existing and emerging mutations and variants,” and that she will continue to work with all governments and regulatory bodies to ensure their treatments go to the “right patients”.
Regeneron told ABC News that its cocktail “still looks good” compared to the worrying variants, including those in India, and that it will continue to test new variants as they emerge.
Lilly’s solo monoclonal antibody treatment, bamlanivimab, was halted in March – first in three western states, then nationwide – for the sake of effectiveness against the variants. The following month, Lilly asked the FDA to revoke the EUA from the treatment – a request that was satisfied the same day – so the company could focus more on its cocktail treatment.
Although Lilly’s antibody treatment has been affected by variants, research so far has shown COVID-19 vaccines to be effective against them. All three licensed vaccines have been shown to be effective against the UK variant, which is the most dominant COVID strain in the United States