... and the race to authorize

Sonia Elijah

Opinion Article

Trial Site News recently were able to review leaked internal emails from the European Medicines Agency (EMA) and meeting report between the agency and Pfizer. The EMA oversees the evaluation and supervision of medicinal products for the European Union. Like other regulatory health bodies, its main responsibility is to protect and promote public health. Snapshots of internal EMA email correspondence; a November 26, 2020, PowerPoint presentation from a pivotal meeting between Pfizer and the agency, as well as a confidential 43-page Pfizer report were provided by an anonymous source because of their trust in Trial Site’s commitment to transparency, accessibility, and accountability in furtherance of a highly ethical, quality-focused and public health-centric biomedical research industry.

Regulatory agencies, like the EMA, the Food and Drug Administration (FDA) in the U.S. and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are chartered to make decisions based to better the public. External influences such as political or media pressure are not meant to be a driving factor in their decision-making, however, when it came to pandemic conditions and the fast-tracked conditional marketing authorization of the Covid-19 vaccines (particularly for the mRNA-based vaccines produced by Pfizer-BioNTech and Moderna), it appears the latter won the day.

The time period of the email correspondence in question stretches from November 10 – 25, 2020, just weeks before the EMA granted CMA (conditional marketing authorization) for the Pfizer-BioNTech Covdid-19 vaccine on December 21, 2020. The FDA granted EUA (emergency use authorization) for this vaccine on December 11 with the MHRA making it first to the finish line on December 2. Here this author uses the term ‘finish line,’ as the emails do reveal an intense, almost competitive-like rush to authorize the Covid-19 vaccines, as quickly as possible. Understandably, the world was gripped by a pandemic at the time, where there was immense impetus to authorize a vaccine to protect people from the novel coronavirus.