Group of agencies constantly monitoring safety of vaccines

By Marie A. Abate

We wish to respond to the recent commentary (DP-July 29) regarding vaccines since it did not accurately address vaccine safety monitoring in the U.S.

While the National Childhood Vaccine Injury Act (NCVIA) of 1986 removed manufacturer liability for vaccine-related injuries to ensure that needed vaccines would continue to be produced, a federal compensation program was created for vaccine injured persons.

The NCVIA also established the National Vaccine Program Office to coordinate immunization-related activities among all Department of Health and Human Services (DHHS) agencies.

These agencies include, but are not limited to, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA), all of which actively monitor vaccine effectiveness and safety.

It takes years to develop a vaccine due to the rigorous testing required by the FDA to show that the vaccine is safe and effective.

Clinical trials for vaccines as well as other medications gather data from hundreds to thousands of volunteers and patients before a product reaches the market. These trials must show that the benefits of a vaccine outweigh the potential adverse effects and risks before the vaccine is available for public use.

Even with extensive pre-marketing testing, adverse effects that are less common or rare might not be detected until a product is used by large numbers in the population. For example, an adverse effect that occurs in only 1 in 100,000 individuals might not be recognized until that product is used in millions of persons. As a result, there are ongoing monitoring and oversight programs for vaccine safety.

The CDC and FDA actively monitor vaccine safety through programs to identify problems that occur after a vaccine is marketed, including side effects that might take weeks or months to develop. These programs, such as the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink, are designed to find adverse effects as early as possible.

For example, continuous and ongoing monitoring of Gardasil vaccine safety by the FDA since the vaccine was available has not identified any new safety concerns among the millions of doses distributed. Adverse effects that have been reported were generally mild and similar to what is already known from prior studies.

Anyone who feels they had a reaction to a vaccine can report this to VAERS through its web site ( Reported data are available to the public. In addition, health professionals are required to report certain adverse effects, and vaccine manufacturers must report all vaccine-related adverse effects to VAERS.

Health care providers are also required to provide patients or their legal guardian with vaccine information statements, created by the CDC, after administering a vaccine. These statements contain a short description of the disease and the risks and benefits of the vaccine.

The dangers from failing to vaccinate should not be overlooked. For example, in 1990 the United States reported 27,872 measles cases resulting in approximately 89 deaths. About 84 percent of those infected were not vaccinated before their first birthday (recommended by the CDC). Of those affected, 6,274 people reported non-fatal complications including diarrhea, ear infections, pneumonia, and encephalitis (brain inflammation).

Recently, Minnesota had its worst measles outbreak in 30 years. As of May 2017, 65 cases occurred during the outbreak, with most involving children under 5 years old. Almost a third of these patients required hospitalization. An additional 8,250 people in the surrounding area were “at-risk” of contracting measles, including three health care facilities, 12 child care facilities and five schools.

Further investigation found that the outbreak started in a suburban community known for having a low vaccination rate.

Regardless of whether the DHHS issues periodic reports, the federal government actively and continuously monitors the safety of all vaccines.

The FDA is mandated to take appropriate action, including removal of a product from the market, if serious or life-threatening adverse effects become evident. Disease outbreaks in unvaccinated individuals can lead to hospitalization and preventable deaths.

As with medications, vaccines may cause side effects, with most vaccine-related reactions being mild. However, the benefits of vaccines for preventing serious diseases or complications outweigh the risks in unvaccinated persons. Thus, CDC vaccination recommendations should be followed.

Marie A. Abate is a pharmacy professor who directs the West Virginia Center for Drug and Health Information. Other members of the Center, including Matthew L. Blommel, PharmD and Olivia Akubuilo, BS, PharmD contributed to this commentary. This commentary should be considered another point of view and not necessarily the opinion or editorial policy of The Dominion Post.

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