Despite endless laymen’s claims that some children’s vaccines cause everything from paralysis to autism, a new Israeli study that analyzed all the changes made by the US Food and Drug Administration (FDA) in the safety profile of all vaccines approved over a 20-year period proves that these shots are safe.

During this period, hundreds of millions of doses of 57 different kinds of children’s vaccines were given in the US. The study, conducted at Tel Aviv Sourasky Medical Center and Tel Aviv University, was just published in the prestigious scientific journal Annals of Internal Medicine under the title “Postmarketing Safety of Vaccines Approved by the US Food and Drug Administration: A Cohort Study.”

Most of the new side effects discovered in vaccines after FDA approval were rare and not life-threatening, stated Dr. Daniel Shepshelovich, the lead researcher who worked with Dr. Noam Tao from Sheba Medical Center and Dr. Dafna Yahav from the Rabin Medical Center. “Vaccines are very safe – much more so than drugs and medical devices whose side effects are many and more dangerous. Vaccines prevent millions of cases of illness, disability and death worldwide each year.”

COVID-19, he added, “highlights what a world looks like with infectious diseases lacking an effective vaccine and how much we depend on them. They allow us all to live our lives without fear of being infected by another person with a dangerous disease such as polio, measles or measles.”

The vaccines given today, he continued, are not only very safe, but they are accompanied by very meager side effects, if any. In addition, the existing system for monitoring and identifying rare side effects that were not detected before the vaccination was approved is efficient and high-quality, he declared.

Children’s vaccines must be very safe to use so as to prevent health damage to a healthy baby and so that the parents know that they are not endangering their children by giving the vaccine. Rare side effects appear years after vaccination may not be detected before approval of a new vaccine.

For this purpose, a special system for the detection of vaccine side effects was established in the US. Called VAERS – Vaccine Adverse Event Reporting System – this system receives about 30,000 inquiries from medical staff and the general public each year and tries to identify and locate those that reflect new or dangerous side effects of existing vaccines.

Any report of a new side effect or impression of a higher-than-expected frequency of a known side effect leads to an immediate examination of the safety of continued use of the vaccine. If necessary, warnings are issued to relevant physicians around the world

In the current study, the researchers analyzed all the changes made by the FDA in the safety profile of all vaccines approved between 1996 and 2015.

The vast majority of vaccines was approved by randomized controlled trials that included many thousands of patients and compared the new vaccine to a previously approved vaccine.

Fifty-eight changes were identified in the safety profile of 25 of the vaccines. The vast majority of new side effects were mild and without significant health consequences, such as mild allergic warnings to various components of the vaccines or momentary loss of consciousness immediately after vaccination among a very tiny number of those vaccinated.

Other warnings dealt with situations in which it was better to avoid vaccination, as in patients who are have suppressed immune systems due to a medical condition, patients with various background diseases, pre-term infants and pregnant women.

This study, the largest and most comprehensive of its kind to date, shows that the system that approves and monitors the use of vaccines presents a high safety profile, even when examining data of many different types of vaccines over many years, the team said.

In recent years, largely due to falsehoods spread on the Internet, there has been a decline in parental approval for vaccination for children. “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,” they concluded.”

 

 

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