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?
- “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”
How does vaccine safety work?
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.