FDA to patients: Yes, the MMR vaccine really is safe and effective

As U.S. measles cases continue to surge at a record-setting pace, FDA on Monday issued a statement in which it reaffirmed the measles, mumps, and rubella (MMR) vaccine is safe and effective.

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Background

CDC data show there have been 626 measles cases reported in the United States as of April 19, putting this year on pace to set the record for the largest measles outbreak since the disease was eliminated from the country in 2000. The largest measles outbreak in the United States since 2000 occurred in 2014, when there were 667 measles cases reported.

As of April 19, measles outbreaks were ongoing in five states, with measles cases in 17 other states reported to CDC.

FDA says MMR vaccine is safe and effective

Peter Marks, director of FDA's Center for Biologics Evaluation and Research, in the statement issued Monday said, "We cannot state strongly enough—the overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health." Marks continued, "Vaccinating against MMR not only protects us and our children, it protects people who can't be vaccinated, including children with compromised immune systems due to illness and its treatment, such as cancer."

According to CDC, the two-dose MMR vaccine is 97% effective against measles.

Marks noted there are potentially mild side effects tied to the MMR vaccine, including rash and fever. He urged parents with concerns about the MMR vaccine to discuss the benefits and risks of the vaccine with their health care providers.

Marks said, "It's an urgent public health priority to monitor these diseases and raise awareness of the importance of timely immunizations, especially as outbreaks are taking hold among unvaccinated populations in this country."

Reaction

Paul Offit, director of the vaccine education center at Children's Hospital of Philadelphia, said FDA's statement is helpful because it provides further proof that the MMR vaccine is safe and effective for parents who are hesitant to vaccinate their children.

Offit noted that 18 studies have confirmed the MMR vaccine's safety, including a decade-long study comparing the outcomes of more than 650,000 children in Denmark who received the MMR vaccine with those who did not. The study found children who received the MMR vaccine did not have an increased risk of autism. Offit said, "I am not sure how many more studies need to be done. I can't believe we are still talking about this issue that from a scientific standpoint has been resolved" (Alltucker, USA Today, 4/22; Weixel, The Hill, 4/22; Maddipatla/Borter, Reuters, 4/22; Sun, Washington Post, 4/22; CDC website, 4/22).

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