- A new comprehensive study spanning 20 years and including 57 vaccines found that they are “remarkably safe”, especially compared to pharmaceuticals and other medical devices.
- The study found that safety-related labeling changes were largely minor, such as pointing out that people with vaccine allergies should stay away.
- The results may comfort those concerned about a coronavirus vaccine that the people responsible for ensuring that the vaccines are safe and effective are competent.
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A new comprehensive study spanning 20 years and 57 vaccines reveals that vaccines are “remarkably safe,” in fact, safer than “almost any other modern medical intervention,” lead author Dr. Daniel Shepshelovich told Business Insider. .
For the study, he and other researchers at Sourasky Medical Center in Tel Aviv analyzed the labels, including changes related to safety, of 57 vaccines that were approved by the FDA between early 1996 and late 2015.
They found that there were 58 label modifications among 25 vaccines due to minor safety concerns. The most common reasons a label was updated, for example, were to indicate that it should not be used in certain populations (such as premature babies) or to point out that people with a vaccine allergy should stay away.
Only one vaccine was withdrawn due to potential safety concerns nine months after approval.
The results demonstrate “the quality and thoroughness” of the FDA-approved and post-marketing surveillance processes, Shepshelovich said.
By similarly studying prescription drugs and medical devices, he and his colleagues “came to expect a trade-off of efficacy versus risk: a drug can help people and save lives, but at the cost of possible side effects,” he said. Shepshelovich. “With the vaccines, there were almost no significant side effects identified, which I think is remarkable.”
The study also showed how effective the FDA’s Vaccine Adverse Event Notification System is.
Most of the vaccines studied, all against infectious diseases, were approved after being safe and effective in randomized controlled trials, the “gold standard” of research methods. The average number of participants in these trials was 4,161, which made them quite large, increasing their credibility.
The research team also examined hundreds of thousands of reports from the FDA’s Vaccine Adverse Event Reporting System (VAERS), a database of negative responses after vaccines, to see how well vaccines are continuously monitored, even after they are proven to be safe and effective.
Of the 58 label modifications tracked over the 20-year period, 95% would include additional safety information, such as warning patients that it is possible to pass out after receiving an injection.
Only one vaccine was withdrawn (a 1998 rotavirus vaccine) due to a rare (potentially somewhere between 1 in 5,000 to 1 in 10,000 babies) but potentially dangerous effect. The VAERS system helped mark it up and remove it from the market within a year.
Because the surveillance system is what tends to generate the updated tags, too, the researchers say their study shows it works and works very well.
Crystal Cox / Business Insider
Jennifer Reich, a sociology professor at the University of Colorado at Denver who studies parents who are hesitant about vaccines, told Business Insider that VAERS is among several “rigorous” systems that monitor vaccine safety and efficacy.
“Some allow voluntary reports and other electronic health records and billing data to examine more subtle things, such as an increase in the emergency room or visits to the doctor after vaccination that could indicate a pattern or adverse reaction,” he said.
“It is a shame so few people are aware of these systems and understand how well vaccine safety continues to be monitored long after a vaccine is licensed.”
Americans are increasingly hesitant about vaccines
Vaccination about vaccines has increased in the United States in recent years.
That is tragic, Shepshelovich said, because “vaccines are one of the greatest achievements of modern public health, saving countless lives and eliminating diseases that were once prevalent, such as mumps, measles and polio.”
“The current COVID-19 pandemic is a terrifying reminder of life with contagious infectious diseases without an effective vaccine,” he added.
But instead of attracting more to the pro-vaccine field, the pandemic has awakened even more skeptics. A May survey, for example, found that only half of Americans would receive a coronavirus vaccine, if one were available, while 31% were unsure.
Shepshelovich said he does not expect his study, which includes all of the pre-coronavirus data, to change the minds of all vaccine skeptics. But he hopes he can influence some who are looking for legitimate evidence to develop his position.
“I would tell people who doubt the vaccine that science and evidence are clearer about the safety of the vaccine than about almost any other modern medical intervention. The benefits are enormous. And the risk is very, very small,” he said. Shepshelovich.
He also said his study highlights the competence of the teams responsible for ensuring that vaccines are safe and effective before reaching the market and beyond.
“We show that the people in charge of approving, regulating and following vaccines have shown that they can be trusted with this responsibility,” said Shepshelovich. “They have done it many times before.”
