Does the FDA Really Think These Data Justify the First Full Approval of a Covid- 19 Vaccine?

Senior Editor of Major Medical Journal: Does the FDA Really Think These Data Justify the First Full Approval of a COVID-19 Vaccine by Dr Suneel Dhand

The FDA should demand that companies complete the two year follow-up, as originally planned (even without a placebo group), writes Peter Doshi, associate editor at The British Medical Journal and assistant professor of pharmaceutical health services at the University of Maryland.

Since COVID-19 vaccine efficacy wanes over time, the question becomes what level of effectiveness will it provide when a person is exposed to the virus? Unlike COVID-19 vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.

The FDA should demand adequate, controlled studies using patient outcomes. Regulators should bolster public trust by ensuring everyone can access the data.