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What's Considered Acceptable Risk for Adverse Reactions Among Popular Vaccines?

By    |   Monday, 22 June 2015 03:23 PM

Concerns about adverse reactions to vaccines have caused more parents and medical professionals to push for increased study of vaccine safety and a determination of how much risk is acceptable.

One illustration acceptable risk for adverse reactions is the rotavirus vaccine. The rotavirus is a common cause of severe diarrhea in infants and young children.

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A child receiving a vaccination against rotavirus has a small chance of developing a condition called intussusception, a bowel obstruction with the potential for symptoms such as acute stomach pain, vomiting, and intestinal bleeding, according to the U.S. Centers for Disease Control and Prevention.

The odds of the rotavirus vaccine causing this reaction are somewhere between 1 in 20,000 to 1 in 100,000, the CDC reported. But the rotavirus vaccines are still on the market, and still widely used in an child immunization program that calls for up to three doses to ensure protection.

Many medical professionals see that incidence and severity of reaction fall within what acceptable risk, given the estimated risks to a person's health of not getting the vaccine.

In 1999, however, a rotavirus vaccine called RotaShield was pulled from circulation in the United States and never reintroduced. The CDC found at the time that RotaShield held an increased risk of intussusception, "20 to 30 times over the expected risk for children of this age group within 2 weeks following the first dose" and "3 to 7 times over the expected risk for this age group within two weeks after the second dose."

Although the third dose showed no increase in risk for the bowel obstruction, the CDC discontinued RotaShield in the United States based on the spikes in risk associated with doses one and two.

In another area under study, the amount of aluminum contained in vaccines, the U.S. Food and Drug Administration reported that vaccines containing aluminum, in six decades of use, "have only uncommonly been associated with severe local reactions."

The FDA concluded that "the benefits of aluminum-containing vaccines administered during the first year of life outweigh any theoretical concerns about the potential effect of aluminum on infants."

"Whenever you talk about safety in anything, in any intervention, there’s never zero risk, ever," Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, told PBS Frontline in 2010. "But when you do an intervention, particularly an intervention in a well person, which is what vaccines are mostly given to, you weigh the risk-benefit," he said. "So if you’re talking about safety in the context of risk-benefit … the safety record of these vaccines is very clear."

A study published in the Journal of General Internal Medicine found that people assessed acceptable risk based on a variety of factors, and they shifted their opinion depending upon their relationship to the person at risk, the New York Times reported

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People hate the risk of bringing bad things on themselves," Dr. Peter Ubel, the study's lead author, told the Times. "but a sense of responsibility makes them overcome these instincts to think about what's best for others. "That may be what makes doctors feel so strongly about recommending to patients what they ought to do."

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Concerns about adverse reactions to vaccines have caused more parents and medical professionals to push for increased study of vaccine safety and a determination of how much risk is acceptable.
adverse reactions, vaccines, vaccinations
Monday, 22 June 2015 03:23 PM
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