FDA Issues Statement on Agency's Continued Confidence in Safety of MMR Vaccine

Peter Marks, MD, PhD, director of the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research, has issued the following statement on the agency's continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine:

"The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities. The World Health Organization recently named vaccine hesitancy one of the top 10 threats to global health. In this time of multiple measles outbreaks, and as we approach National Infant Immunization Week, we want to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases.

"The MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. However we’re seeing an increasing number of outbreaks of measles in communities across the country, including those in New York, New Jersey, Washington, California, and Michigan.

"Considered eradicated within the U.S. since 2000, measles has persisted in other areas of the world where the vaccine is not as readily available, including countries in Europe, Asia, the Pacific Islands, and Africa. Unvaccinated U.S. residents may be exposed to measles while they are abroad and bring the disease back into the U.S. and spread it to others. Worldwide, about 20 million people get measles each year. According to the Centers for Disease Control and Prevention (CDC), there have also been outbreaks of mumps reported. 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.

"These diseases start with symptoms that may mirror the common cold, but they can cause serious illness and in some cases, even death. Measles – a respiratory disease that causes a skin rash, fever, cough and runny nose – can be dangerous, especially for babies and young children. It is one of the most contagious diseases and can cause severe complications, including pneumonia, swelling of the brain and death. In fact, one to two children out of every 1,000 who contract measles dies from complications of the disease and one in four people who get measles need to be hospitalized. Mumps causes fever, headache, loss of appetite and the well-known sign of swollen cheeks and jaw from the swelling of the salivary glands. Complications, though rare, can include deafness and meningitis (an infection of the lining that surrounds the brain and spinal cord). Rubella, once a common disease that occurred primarily among young children, causes fever, rash, and -- mainly in women -- arthritis. Rubella infection during pregnancy can also lead to birth defects.

"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.

"Vaccinating against measles, mumps and rubella 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.

"We do not take lightly our responsibility to ensure the safety and effectiveness of vaccines, and work diligently to assess safety and effectiveness of all licensed vaccines for their intended uses. The MMR vaccine is very effective at protecting people against measles, mumps, and rubella. It also prevents complications caused by these diseases. And we have nearly 50 years of experience and evidence supporting that fact. In fact, according to the CDC, two doses of the MMR vaccine beginning at 12 months of age (the recommended dosing schedule) are 97% effective against measles, 88% effective against mumps, and 97% effective for rubella.

"Like many medical products, the MMR vaccine has known potential side effects that are generally mild and short-lived, such as rash and fever. If parents have concerns about these side effects, we recommend that they speak with their health care providers about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases.

"The FDA will continue to closely monitor these outbreaks of vaccine-preventable diseases alongside our federal partners at CDC and the Department of Health and Human Services, and will provide any new information about vaccine safety or effectiveness to the public. But just to be clear, the FDA has determined that the MMR vaccine is both safe and effective in preventing these diseases. We join our colleagues at HHS, CDC, National Institutes of Health and state and local health departments across the country in the continued effort to encourage vaccinations against these preventable diseases."

Source: FDA