Univadis Medical News 2020.12.07

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) allowed the use of one of the first vaccines against SARS-CoV-2 last week under an expedited emergency authorization procedure. With the availability of the vaccine came more information about its  clinical results to date , and guidance and training materials for UK physicians.

Reactions from other health experts and regulators were mixed. American infectious disease expert Anthony Fauci initially criticized the UK’s decision as hasty, he later apologized for his comments. The European Medicines Agency (EMA)  also stated that the UK moved too quickly and that the EMA’s longer procedure was more appropriate.

Other reporting pointed out that the the UK’s expedited process relies more on drug manufacturer reports, while the FDA reanalyzes raw data from the trials.

While many countries have promised transparency in vaccine-related matters, it remains to be seen what, if any, the effects of new vaccines will be when expanded beyond the tens of thousands of trial volunteers to the hundreds of millions to billions of vaccine recipients. Fortunately, most initial trials’ results have been encouraging, with high efficacy rates and low numbers of adverse events.