The Province

Vaccinatio­n safety — really no question about it

- Michael Roizen, MD, and Mehmet Oz, MD

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 Americans are 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 “co-ordinating 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 involved in making sure 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.

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.

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 doctoroz.com/ article/book-excerpt-you-having-baby-vaccines.

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