Vaccine Delays in Europe Lead to German Direct Purchase of $486m of Lilly & Regeneron Monoclonal Antibody Products Despite No Formal Approval

Vaccine Delays in Europe Lead to German Direct Purchase of $486m of Lilly & Regeneron Monoclonal Antibody Products Despite No Formal Approval

As frustration mounts in places such as Germany with what is perceived as a slow and inefficient vaccine rollout, calls for other treatments, such as monoclonal antibodies, grow. This has led to a large order of the novel therapy from two major American biopharmaceutical companies. Although the EU hasn’t approved the use of monoclonal antibodies from Regeneron and Eli Lilly, Germany went ahead and ordered 200,000 doses from the two companies for a deal of $486 million ($2,430 per dose). Of course, as TrialSite has reported, these drugs are not proven yet, cumbersome, expensive to administer, and don’t have the support necessarily of prominent physician groups in the U.S. even though the U.S. Food and Drug Administration (FDA) issued an emergency use authorization. The deal coincides with growing COVID-19 cases and mounting frustration with the pandemic, shares German health minister Jens Spahn. In a goodwill gesture, the German government will cover the cost of the actual doses but it’s not clear if there will be consumer costs associated with the administration of the novel therapies, which require infusion facilities.

The European Medicines Agency hasn’t made any formal decis...

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