Robert M. Kaplan and Sander Greenland
A new bivalent COVID vaccine will become available this week.
Last week, along with an international group of physicians and scientists, we published a study suggesting that the risks of COVID-19 vaccines may be greater than previously reported. Using publicly available data from Pfizer and Moderna studies, we found one serious adverse event for each 800 vaccinees. That translates to about 1,250 serious events for each million vaccine recipients. DHHS reports the rate for other vaccines is only 1 or 2 per million.
Many physicians and scientists believe that vaccination programs are the key to ending the coronavirus pandemic. Some warn that our analysis might harm public health by stimulating more vaccine hesitancy. Yet, if some concerns are valid, remaining quiet could also result in harm and further erode public trust in science.
The FDA used results from mouse experiments and the original vaccine trials to reassure the public that the new boosters are safe. Is this evidence sufficient?