The continued success of the global vaccination effort relies upon both the use of safe vaccines and public confidence in their benefit and safety. We need to assess and quantify potential vaccine risks using scientifically rigorous methods in a timely manner for benefit-risk decisions. Uncommon Adverse Events Following Immunization (AEFI) are rare and include outcomes that are delayed and outcomes that occur beyond clinical trial study follow‐up. AEFI, including those among subpopulations excluded from initial clinical programs (e.g., pregnancies, immune-compromised), can only be evaluated in post introduction pharmacovigilance (PIPV) studies. Historically, PIPV has relied on spontaneous reports or passive surveillance for AEFIs. Such passive systems suffer from many weaknesses such as biased/under-reporting, lack of denominators and comparison groups. They can generate hypotheses of new safety concerns but cannot test them to see if they are likely to be caused by vaccines or not.
- New Zealand takes first steps to monitor the safety of COVID-19 vaccines February 18, 2021
- As Millions Get Shots in USA, the F.D.A. Struggles to Get Safety Monitoring System Running February 15, 2021
- Understanding mRNA COVID-19 Vaccines January 11, 2021
- Ensuring safety of COVID-19 vaccines November 26, 2020
- Will it be safe? Vaccine safety science from the Cow Pock to COVID-19 November 25, 2020