Health: Vaccination safety — no question about it

After we noticed the safety of vaccines here in the U.S. being called into question, we wanted to let you know the facts: Not only is the quality and integrity of your vaccines held to the highest standards, but every year the Centers for Disease Control and Prevention goes to great lengths to provide an easy-to-follow, appropriate vaccine schedule that’s as safe as possible for children, adolescents and adults.

Perhaps you weren’t aware that you’re also the beneficiary of a robust National Vaccine Plan that’s administered by the office of the secretary of health from Health and Human Services. That has helped greatly to improve vaccine safety over the past three decades.

Getting a Vaccine Approved

It all starts with the Food and Drug Administration. No vaccine can be administered unless it’s approved by the FDA. That means it goes through extensive and expensive phase I, II and III clinical trials.

Then the Advisory Committee for Immunization Practices, chaired by the director of the CDC, weighs in. The ACIP is an advisory panel made up of 15 voting members (mostly M.D.s), eight ex officio members and 29 liaison organizations.

The ACIP was established in 1964 by the surgeon general to help ensure safety in vaccine manufacturing, not long after Jonas Salk developed the first effective polio vaccine. To become part of the recommended vaccine schedule, the vaccine not only must go through clinical trials, but the developers must subject their vaccine to the lengthy process of data presentation and review. It can take months or years before an ACIP vote is even considered.

To gain a recommendation, the ACIP requires the use of an explicit evidence-based format. All meetings are open to the public.

Protection from Adverse Reactions

A representative from ACIP also serves as a liaison on the National Vaccine Advisory Committee, which was created in 1987. A division of the Office of Health and Human Services, the NVAC is the federal advisory committee responsible not only for recommending “ways to achieve optimal prevention of human infectious diseases through vaccine development,” but also for providing “direction to prevent adverse reactions to vaccines.”

The NVAC is made up of 11 members with various degrees, from M.D.s (six) to M.B.A.s and Ph.Ds. Their recommendations go to the National Vaccine Program Office. The NVPO is responsible for “coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities” to make sure the goal of the National Vaccine Plan — the prevention of infectious diseases through immunizations — is met. The National Vaccine Plan was created in 2010.

Other federal agencies that are involved in making sure your vaccinations meet the highest standards include: the Agency for Healthcare Research and Quality; the Health Resources and Services Administration; the Department of Defense; the U.S. Agency for International Development; the Veterans Health Administration; and the Department of Veterans Affairs. There are many state and local agencies involved, too.

Since the ACIP was established, the number of vaccines included in the recommended child/adolescent immunization schedule (for birth through 18 years) has increased from six to 16. Only one vaccine was removed from the schedule, and that was in 1972, when smallpox was declared eradicated.

If you still have doubts about the safety of vaccines, we hope this will put them to rest: We (Drs. Roizen and Oz) spent a month reviewing every study on vaccine safety and interviewing 150 experts on all sides of the issue. Our conclusions: Vaccines aren’t perfectly safe, but the chance that the childhood vaccines will effectively and safely prevent disease is more than 40,000 times greater than the chance that they will cause any serious side effects. So getting your childhood vaccines is like winning the lottery.

You can see a synopsis of our findings in a chapter in “YOU: Raising Your Child.” Read it at

Mehmet Oz, M.D. is host of The Dr. Oz Show, and Mike Roizen, M.D. is Chief Wellness Officer and Chair of Wellness Institute at Cleveland Clinic. To live your healthiest, tune into The Dr. Oz Show or visit

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