The distribution of COVID-19 antibody treatments from Eli Lilly and Regeneron Pharmaceuticals has been put on hold by the US government since they’re unlikely to be effective against the Omicron coronavirus variant.
Lilly’s drug, first authorized for emergency use in February, is a cocktail of two antibodies, bamlanivimab with etesevimab.
Monoclonal antibodies are lab-made molecules that mimic the natural antibodies the immune system produces to ward off viruses by attaching the virus, neutralizing it, and preventing its replication in new cells.
The antibody drugs, which are only administered via injection or infusion by a nurse or other healthcare professional, are different from vaccines, which train the immune system to fight off the virus and to produce antibodies.
The US Food and Drug Administration (FDA) and the office of Assistant Secretary for Preparedness and Response said in the joint statement that the allocation of the therapies will not continue until new data emerges on their efficacy.
Omicron has been resurrecting restrictions and stretching the country’s testing infrastructure since it became the dominant strain in the US with lightning speed.
Eli Lilly and Regeneron’s treatments have been found to lose most of their effectiveness when exposed to Omicron in laboratory tests, German researchers have also confirmed.
FDA has issued last week emergency authorization of Eli Lilly’s monoclonal antibody drug in children under the age of 12, including newborn babies. The authorization also allowed the therapy to be used as a preventive measure in children who were exposed to the virus.
This is the first antibody drug cleared for use to treat mild to moderate symptoms of young children at high risk of developing severe cases – including hospitalization or death – which have tested positive for Covid-19 or have been exposed to the virus.
FDA has based its authorization on clinical trial data of pediatric and infant patients after the initial approval that only covered children aged 12 and older weighing at least 40 kg. That is also the limit for antibody treatments that Regeneron developed with GlaxoSmithKline and Vir Biotechnology.
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