FDA-approved vaccines ‘remarkably safe’ new study finds
“Vaccines are one of the great achievements of modern medicine."
By MAAYAN JAFFE-HOFFMANDr. Daniel Shepshelovich(photo credit: LIOR TSUR / SOURASKY)Vaccines are “remarkably safe,” a new study by researchers from Tel Aviv University and Sourasky Medical Center has shown.The group, led by Dr. Daniel Shepshelovich of TAU’s Sackler Faculty of Medicine, studied 57 vaccines that were approved by the US Food and Drug Administration between 1996 and 2015 that yielded 58 safety-related issues associated with 25 of them.A large proportion of safety issues were identified through the FDA’s Vaccine Adverse Event Reporting System (VAERS), and those which were identified were of limited clinical significance, rare and not life-threatening, the study found.It said this indicates that the initial approval process is solid and proves “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 occurring at a higher-than-expected frequency, leads to an immediate examination of the safety and continued use of the vaccine.In only one case in the last 20 years was a vaccine pulled off the market. The RotaShield vaccine for rotavirus was removed within months of approval after it was found to have mild bowel side effects in one out of every 5,000 to 10,000 people who took it.The conclusion: 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 how important vaccines are to humankind. A press release explained that vaccines prevent millions of cases of illness, disability and death worldwide each year.“The coronavirus highlights what a world would look like with infectious disease without an effective vaccine – and how much we depend on effective vaccines given to the general public to allow us to live our lives without fear of being infected by another person with a dangerous disease such as polio, measles or mumps,” the statement said.The study comes after a poll published earlier this summer by the Associated Press-NORC Center for Public Affairs Research found that only about half of Americans say they would get a COVID-19 vaccine if scientists succeed in creating one.“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 to both the health of those children and the health of the general public,” Shepshelovich said.Their research was published this week by the peer-reviewed Annals of Internal Medicine.
