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 TrialsiteN

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 decision on American-based monoclonal antibody products as of yet, despite the emergency authorization edicts by the FDA across the Atlantic. With vaccine delays and growing frustration, Germany sought to strike out and do its own deals with prominent American companies.

Vaccine Delays in Europe

Both Pfizer/BioNTech and AstraZeneca report “production problems” that are unfortunately hampering COVID-19 vaccine rollout in Europe, reports Euronews. Recently, a European Commissioner named Stella Kyriakides issued a tweet sharing a “deep dissatisfaction” with the process. The AstraZeneca vaccine is expected to be approved this week but delays are anticipated as is occurring with the Pfizer/BioNTech vaccine. This raises concern as new highly transmissible strains emerge; the UK reports record daily hospitalization and deaths associated with COVID-19.

Meanwhile, Pfizer reported that less vaccine doses would be available in late January and February due to quality tests at a Belgium production facility.

Tension Builds in Deutschland

As the second wave of the pandemic is worse than the first, tensions mount across the country. Health minister Spahn cautioned all against finger pointing and blame in this pandemic in comments to media outlet Bild. “We should be careful that 2021 does not become the year of blame,” directed Spahn emphasizing understanding fault can descend into counter productive dynamics, reported DW. The health minister acknowledged that their government should have acted with more force against the coronavirus back in October.

Germany Makes its Own Moves

In Germany, the monoclonal antibody products known as Bamlanivimab (Lilly) as well as the contact of Casirivimab and Imdevimab from Regeneron aren’t formally approved in any way in Germany either. However, a spokeswoman for the ministry of health there shared that “ in principle,” the regulator there known as the Paul Ehrlich Institute, the research center and regulatory body will allow use of the drugs on a “case by case basis” giving discretion to local physicians.

What about Generics?

With University of Oxford announcing The Principle Trial—involving the testing of both ivermectin and Favipiravir as potential low cost, easy to administer treatments, at least for early onset COVID-19 cases—could Germany possibly sponsor a rapid test? Favipiravir is approved in a number of countries, including Russia. While vaccines are in delay, monoclonal antibody products, while showing some promise (they were given to Donald Trump when he was diagnosed with COVID-19), are expensive and cumbersome to administer. Perhaps Germany and other individual EU nations should expand their horizon and look to what other primarily low to middle-income countries are looking into due to necessity.

Source: DW