A review of 58 different changes in vaccine labels made between 1996 and 2015 has shown very few dangers in vaccination, and the changes that were made were primarily to ensure that people vulnerable to side effects or allergies were protected, They found.
“These data underscore the robustness of the vaccine approval and post-marketing surveillance processes and confirm vaccination of the population as an important public health strategy,” the team at the Sourasky Medical Center in Tel Aviv wrote in their report. , published in Annals of Internal Medicine.
Vaccine experts worry about a small but expressive group of vaccine skeptics who have questioned the safety of vaccines, which go through a rigorous testing process before being approved by the US Food and Drug Administration. And other global drug regulators.
The director of the National Institutes of Health, Dr. Francis Collins, said he was concerned about some Americans’ skepticism about vaccines and said it could affect people’s acceptance of the vaccine.
The first phase III trial of a possible coronavirus vaccine began in the United States on Monday, and Collins emphasized that while development was rapid, the NIH was not cutting corners in safety.
“One of the things that worries me is that there is a lot of skepticism in the United States about the vaccine and something like 25% of people say that I’m not sure if I take that vaccine,” Collins told CNN’s Wolf Blitzer to earlier this month.
Collins said it is important that everyone receive the vaccine when it is available. “It will be really critical to do that if we are to develop the level of herd immunity across the country so that this does not come back next time, next fall, next summer. We will not. You know,” he said.
When asked if he was concerned about the anti-vaxxer movement, Dr. Anthony Fauci said, “Yes, I do.”
“We have to admit and realize that there is an anti-vax movement that we have had to fight with in this country,” said Fauci, director of the National Institute of Allergy and Infectious Diseases, speaking earlier this month at PBS Newshour. . .
“I think the solution to that would be community involvement and community outreach, to get trusted people in the community to come out and explain to them the importance of not just participating in the vaccine trial, but the importance of, when the vaccine has been shown to be safe and effective for taking the vaccine. “
It could save lives, he said, “and it would certainly be the solution to this terrible pandemic.”
Fauci said he is “cautiously optimistic” that the country will have a vaccine by the end of 2020 or the beginning of 2021. “When it comes to vaccines, things cannot be guaranteed,” he said.
“I feel optimistic, nobody guarantees it, but I feel optimistic, that we will have a vaccine, one or more, that we can start distributing to people,” added Fauci.
Post-marketing vaccine monitoring
Once approved and released for public use, the vaccines will still be monitored, to ensure that there is no need to modify how the vaccines are used after they have reached the market and have been used in hundreds of thousands or millions of people.
The Tel Aviv team analyzed each label change with 25 vaccines manufactured since 1996. Most were done in response to reports made to the Vaccine Adverse Event Reporting System. Around 30,000 of these reports are made each year, and many are found to be unrelated to vaccination, after all.
“The FDA continually monitors VAERS for unexpected patterns or changes in adverse event rates,” the researchers noted. They found that it seemed to work well to identify hazards.
The most common reason for a safety-related labeling change was an expansion in population restrictions, for example, recommending that pregnant women or immunocompromised individuals not be vaccinated with live viruses. These accounted for 36% of the changes.
The team found that allergy-related warnings, often with the latex used in the packaging, accounted for another 22% of the label changes. Twelve changes in the warning label warned of the risk of fainting after vaccination.
The only vaccine that was withdrawn for safety reasons, the RotaShield rotavirus vaccine, was withdrawn from the market less than a year after its initial marketing. It was linked to a rare condition called intussusception, which can cause the intestines to become entangled in babies. It can be fatal
“The safety issue that triggered the single vaccine recall was quickly identified by the post-marketing surveillance program,” the researchers said.
The research found that seasonal flu vaccines, which were the most common vaccine in the study population, were less likely to be associated with safety modifications. Three of 21 flu vaccines had a modification, compared to 22 of 36 vaccines for other infections.
The average time between vaccine approval and a safety modification was five years, and the number of safety modifications that occur each year has been stable, the researchers said.
“With such an impressive track record, vaccines are rightly regarded as one of the greatest achievements in biomedical science and public health,” they wrote.
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