What Do Vaccine Safety Offices Do and Why Closing One Is a Bad Idea

Safety Team
Updated Dec 15, 2020
3 min read

Across the nation, doctors and healthcare professionals are scrambling to produce a viable vaccine to combat the COVID-19 pandemic. Once a vaccine arrives, patients who receive it must be closely monitored to understand the long-term health impacts. 

But what happens when the office tasked with this vital work no longer exists in its original form?

In March 2019, the National Vaccine Program Office shut its doors and was merged with the Office of Infectious Disease and HIV/AIDS Policy (OIDP). Secretary of Health and Human Services (HHS) Alex Azar said the organizational shift would “increase operational efficiencies by eliminating program redundancies and decreasing program costs,” as reported by the New York Times

The Pfizer-BioNTech vaccine has been approved by the FDA with COVID-19 vaccinations already in process for frontline health care workers and nursing home residents. However, the National Vaccine Program Office designed to monitor the safety of the vaccine after widespread use is no longer a standalone office. 

“The office was not ‘closed,’ but was merged with the Office of Infectious Disease and HIV/AIDS Policy and was strengthened. All the functions continue in this new organizational structure,” said an HHS spokesperson in a statement. 

What’s the National Vaccine Program?

The mid-1970s saw a rise in public concern over the safety of vaccines. These public concerns gave way to the National Childhood Vaccine Injury Act (NCVIA), passed by Congress in 1986. One result of the NCVIA was the creation of the National Vaccine Program Office (NVPO). The NVPO was created to “coordinate immunization-related activities between all Department of Health and Human Services agencies.” These agencies include big names like the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). Specifically, the National Vaccine Program is tasked with the following according to the HHS:
  • “Vaccine research”
  • “Vaccine development”
  • “Safety and efficacy testing of vaccines”
  • “Licensing of vaccine manufacturers”
  • “Production and procurement of vaccines”
  • “Distribution and use of vaccines”
  • “Necessity and effectiveness of vaccines”
  • “Adverse events related to vaccines and immunization activities”
These responsibilities are a lot to handle. Because the NVPO was designed as a coordinating entity, all of these duties are performed in concert with the various other health agencies in the United States.

How does vaccine safety work?

Vaccines go through an exhaustive testing process before they ever reach the market. Once a vaccine is approved for the general population, continued safety monitoring is required to ensure unexpected adverse events are found and understood, so that they can be compensated for during widespread vaccination. To accomplish these vaccine safety protocols, our government health agencies several tactics. Each one is an important part of the puzzle that makes up our nation’s vaccine safety response. Let’s look at three of these tactics to see how they fit into the bigger picture.

Vaccine Adverse Events Reporting System (VAERS) 

This is an “early warning system” for any adverse side effects that may occur after a patient receives a vaccine. VAERS is managed by the CDC and FDA, and the system uses data sourced from a variety of places, such as doctors, healthcare professionals, vaccine companies—and even patients themselves. Using the data, VAERS can track unexpected patterns as they come up. These reporting patterns could signify a possible safety issue with the vaccine. If a pattern emerges, further evaluation is conducted and necessary action is taken.

The Vaccine Safety Datalink (VSD)

This is another data-based reporting tool. It’s run as a collaboration between the CDC and various other health organizations nationwide. But instead of using self-reporting like VAERS, VSD relies on medical record databases. By drawing data from millions of medical records, VSD can look at vaccine safety in a large population. Then, VSD can run comparisons on the data to tell if any of the various side effects reported across the nation are, in fact, linked to vaccinations.    

Clinical Immunization Safety Assessment Project (CISA)

This is a project helmed by the CDC that draws on the expertise from the nation’s top academic medical centers. Under CISA, vaccine safety experts build vaccine case studies and recommendations. This research helps to identify any potential adverse effects associated with vaccinations. The findings can then be used in consultations with U.S. healthcare providers who are issuing the vaccine. 

Why is vaccine safety important?

Public health is the first reason why continued vaccine safety monitoring is vital, even after the vaccine is in use. Doctors don’t want to hurt people; they want to help them. By collecting and analyzing patient and health data from across the country, U.S. health agencies can stay on top of any side effects a vaccine might contain, even for small subsections of a greater population. Aside from health concerns, vaccine safety contributes to public trust in the vaccination process. According to a recent Gallup Panel Survey, 63% of Americans say they’re willing to get vaccinated. This number is up compared to an October poll showing 58% of Americans were willing.

The Bottom Line

Although the NVPO still exists in some form as a part of the OIDP, it’s reformation has caused concern. Hopefully, the tools at our national health agencies’ disposal will help to bolster the effects of a vaccine when it comes, while reducing any negative side effects that may occur in large populations. Clear communication and transparency from health agencies is usually the best cure for any doubts that come along with the introduction of new medicine. Photo By AFP / Getty Images 

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