The group, led by Dr. Daniel Shepshelovich of TAU Sackler School of Medicine, studied 57 vaccines approved by the Food and Drug Administration between 1996 and 2015 that yielded 58 safety-related problems associated with 25 of them. They found that a large proportion of safety concerns were identified through the FDA’s Vaccine Adverse Event Notification System (VAERS) and that those identified were of limited clinical importance, infrequent and they were not life threatening.
The study said this indicates that the initial approval process is robust and demonstrates “the robustness of the vaccine approval system and post-marketing surveillance,” as well as its reliability and comprehensiveness.
Any detection of a new side effect, or a known side effect that occurs more frequently than expected, leads to an immediate review of safety and continued use of the vaccine. In just one case in the past 20 years, a vaccine went off the market. The RotaShield vaccine for rotavirus was phased out a few months after approval after it was discovered to have mild intestinal side effects in one in 5,000 to 10,000 people who took it.
The bottom line: vaccines are very safe, much more so than drugs and medical devices whose side effects are many and more dangerous, according to the study.
Shepshelovich said they did the research to help show the importance of vaccines to humanity. A statement explained that vaccines prevent millions of cases of illness, disability and death worldwide each year.
The study comes after a survey published earlier this summer by the Associated Press-NORC Public Affairs Research Center that found that only half of Americans say they would receive a COVID-19 vaccine if scientists manage to create it.
“Vaccines are one of the great achievements of modern medicine, and any information that strengthens the safety of their use and can help persuade parents of children not to avoid vaccines contributes both to the health of these children and to the health of the general public. ” Shepshelovich said.
Their research was published this week by peer-reviewed. Annals of internal medicine.
