UK First Country to Approve Pfizer-BioNTech Vaccine

On Wednesday, Great Britain became the first nation to approve distribution of the COVID-19 vaccine recently developed by American drug-maker Pfizer, in conjunction with German company BioNTech. The decision is expected to put extra pressure on the US Food and Drug Administration to accelerate approval for the vaccination to be distributed in the United States.

The FDA, which has the most stringent criteria in the world for approving the use of pharmaceuticals, has been under pressure from the Trump administration to move quicker in reviewing the vaccine test data for approval. Critics have expressed concern that the push is politically motivated and emergency use authorization should not take priority over safety and effectiveness evaluation by career health and science experts. The FDA has a panel meeting scheduled to begin their review process on December 10.

On Tuesday, White House chief of staff Mark Meadows held a meeting with the commissioner of the FDA, Stephen Hahn, asking for an explanation as to why the process is not moving as fast as the Trump administration expects. Commissioner Hahn stated the rigorous evaluation involves inspecting safety and efficacy data thoroughly, as well as independent reviews of statistical results of the clinical trials. Details of trial results have only been in the form of press releases thus far, not in expert medical journals, which is the customary process for releasing definitive evaluation data.