As Fauci Touts Flu and COVID-19 Shots, Study Finds Vaccines Are 'Remarkably Safe'

Vaccines have been found to be "remarkably" safe in a study spanning 20 years.

Amid concerns that the speed at which the COVID-19 vaccine is being developed may compromise its safety, which have been dismissed by experts including Dr. Anthony Fauci, the co-author of the study said the research shows the vaccine-making process is safe.

Daniel Shepshelovich, deputy chief of medicine at Israel's Tel Aviv Medical Center and co-author of the paper published in the journal Annals of Internal Medicine, told Newsweek via email the study did not look at the safety of potential COVID-19 vaccines.

However, he said: "When a vaccine for COVID-19 is approved, take it. I know I will. I currently work in a general medical department transformed into a COVID-19 unit. When we will have an approved vaccine, I might be one of the first people offered one. And I will take it without the slightest hesitation."

Over the weekend, Fauci urged members of the public to get the flu vaccine to "blunt" the disease's effect amid the COVID-19 pandemic. And last week, Fauci, a member of the White House coronavirus task force, said the speed at which COVID-19 vaccines are being developed does not affect their safety, and the risk was a financial one.

He has previously expressed worry that herd immunity from a vaccine would not be reached due to the "alarmingly large" percentage of the U.S. population which is anti-science, anti-authority, and anti-vaccine.

To conduct the study, Shepshelovich and colleagues investigated all 57 vaccines approved by the U.S. Food and Drug Administration (FDA) over a 20-year period. The approval of 53 were supported by randomized controlled trials, with an average of over 4,161 participants.

The team examined the labels initially put on vaccines approved between January 1, 1996, and December 31, 2015, and took into account the most recent labels published before January 1, 2020. The team consulted a database on the FDA website, a Freedom of Information Act request to the agency, and the DailyMed website.

Licensing new vaccines involves "extensive and time-consuming" pre-approval studies, the researchers said. Once this happens, vaccines continue to be monitored for side effects in diverse populations, and for long-term problems. In 1990, the FDA established the Vaccine Adverse Event Reporting System for this purpose, which can be used by everyone from healthcare workers to the public.

The most common vaccines in the study were for seasonal flu, followed by combinations of vaccines for diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, hepatitis B and hepatitis A, meningococcus, human papillomavirus, and rotavirus.

A large proportion of safety issues were found through programs set up for that purpose, and were not serious, according to the study.

The researchers wrote in their conclusion: "Over a 20-year period, vaccines were found to be remarkably safe."

During the period of study, there were 58 safety-related changes to labels after FDA approval, in 25 vaccines. 55 were related to additional safety information, and three to the removal of prior warnings and precautions.

The most common safety issue was related to which populations could have the respective vaccines, followed by allergies—mostly due to packaging containing latex.

Only one vaccine, for rotavirus, was withdrawn, due to the risk of intestinal blockage. The problem was "swiftly identified" by the surveillance program, the team said.

The study was limited, the authors wrote, because the source of the data may not represent all safety data received and processed by the FDA.

"Vaccines are rightly considered as one of the greatest achievements of biomedical science and public health," the authors wrote, citing research showing they have greatly reduced illness, disability and death from many infections, including measles, mumps, and rubella.

But in recent years, vaccination rates have fallen, "partly driven by reduced public trust and parental concerns over safety," they wrote, and have been linked to reemergence of infections like pertussis and measles.

"In this context, we believe our findings are of considerable importance for public health," they said.

Shepshelovich was surprised by "how safe vaccines were." His team have done similar studies in prescription drugs and medical devices and came to expect a similar trade off in efficacy and risk. "A drug can help people and save lives, but at a cost of potential side effects. With vaccines, almost no significant side effects were identified, which I think is remarkable."

Shepshelovich said the message for those worried about vaccines is that the science and the evidence are "clearer on vaccine safety than on almost any other modern medical intervention. The benefits are huge. And the risk is very very small."

He went on: "The reported findings do not support vaccine hesitancy; rather, the aggregated data clearly shows that vaccines are safe, and that public vaccination should remain as a major public health strategy."

Regarding the COVID-19 pandemic and the dozens of vaccines under development, Shepshelovich said the study shows "the people in charge of approving, regulating and following vaccines have proved that they can be trusted with this responsibility. They have done this (many times) before."

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A stock image shows a child having a vaccine. Researchers have investigated the safety of vaccines.