One of the great unsung heroes in my lifetime was a polymath named Frances Oldham Kelsey who, in an era when women had to overcome so much, earned both a PhD in pharmacology(1938) and an M.D.(1950). In 1960 she became “one of just a handful of medical officers” at the FDA.
“One of the first applications she was assigned was for thalidomide, which was already available in dozens of countries around the world. Dr. Kelsey, despite constant pressure from the company, refused to approve the application because of its inadequate evidence.”
(See: https://www.fda.gov/about-fda/virtual-exhibits-fda-history/frances-oldham-kelsey-medical-reviewer-famous-averting-public-health-tragedy )
The relevance to the horrid times we are living through now? Well, the FDA has released its guidance for how a vaccine candidate can achieve approval and there is a there there! No October surprise, no early rush to judgement via a “Emergency Use Authorization”. This is so important because an early approval, without good data, would rival the horrors of thalidomide’s early approval outside the United States and, moreover, poison the well for all Covid 19 vaccines that might follow.
To quote the all important safety section from the “Development and Licensure of Vaccines to Prevent COVID-19” (https://www.fda.gov/media/139638/download)
F. Safety Considerations
The general safety evaluation of COVID-19 vaccines, including the size of the safety database to support vaccine licensure, should be no different than for other preventive vaccines for infectious diseases. Safety assessments throughout clinical development should include:
- Solicited local and systemic adverse events for at least 7 days after each study vaccination in an adequate number of study participants to characterize reactogenicity (including at least a subset of participants in late phase efficacy trials).
- Unsolicited adverse events in all study participants for at least 21–28 days after each study vaccination.
- Serious and other medically attended adverse events in all study participants for at least 6 months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms (e.g., those that include novel adjuvants).
- All pregnancies in study participants for which the date of conception is prior to vaccination or within 30 days after vaccination should be followed for pregnancy outcomes, including pregnancy loss, stillbirth, and congenital anomalies.