Even though COVID-19 vaccines are being developed more quickly than usual, vaccine safety is still a top priority in all phases of vaccine development, vaccine approval, and post-approval vaccine monitoring.
While steps are being streamlined or overlapped, none of them are being skipped.
Below is what public health and medical experts in the U.S. are doing to make sure any COVID-19 vaccine approved in the U.S. is safe and works like it’s supposed to.
Just like all other vaccines in the U.S., COVID-19 vaccine candidates are first tested by vaccine manufacturers/researchers in three phases of clinical trials. The purpose of these trials is to see if the vaccine candidates are safe and effective. During the Phase 3 clinical trials, researchers compare the health of those who get the vaccine to that of those who didn’t. This helps researchers spot common side effects and see if those in the vaccinated group are less likely to get sick than those who got a placebo. (A placebo is a harmless, “fake” vaccine given to half the people in the clinical trial. People in the vaccine clinical trial are not told whether they received the actual vaccine or the placebo), COVID-19 vaccine trials done so far have generally included tens of thousands of people, including people of color.
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Researchers follow everyone in the clinical trials who gets the vaccine for at least two months after their last dose to make sure there aren’t any lingering issues or side effects that could be caused by the vaccine.
Vaccines and Related Biological Products and Advisory Committee (VRBPAC)/FDA
Before being approved for use in the U.S., the FDA’s Vaccines and Related Biological Products and Advisory Committee (VRBPAC) decided if each COVID-19 vaccine met its safety and effectiveness standard. If the known and potential benefits outweigh the known and potential risks of the vaccine, the FDA can make the vaccine(s) available for use in the U.S. by approval or emergency use authorization (EUA).
As of December 21, two COVID-19 vaccines (from Pfizer-BioNTech and Moderna) have been approved by the FDA for emergency use authorization in the U.S.
Advisory Committee on Immunization Practices (ACIP)/CDC
After each COVID-19 vaccine is authorized for emergency use (EUA) or approved by the FDA, the ACIP will meet to carefully review the available scientific research and make recommendations for the use of that particular vaccine. The CDC Director will review ACIP’s recommendations and decide whether or not to make them “official”.
As of December 21, the Pfizer-BioNTech and Moderna COVID-19 vaccines have been recommended for use in the U.S.
Post-Approval Vaccine Safety Monitoring Systems
After each COVID-19 vaccine is authorized for emergency use in the U.S. by the FDA, there are a number of vaccine safety monitoring systems that are working together to watch for rarer possible side effects that may not have been seen in the vaccine’s clinical trials.
Some of the vaccine safety monitoring systems have been around for a long time to monitor vaccine safety after being licensed for use in the U.S. population. These include:
- Vaccine Adverse Events Reporting System (VAERS) -U.S. system for reporting adverse events that happen after vaccination. Anyone can report to VAERS. Reports of side effects that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies.
- Vaccine Safety Datalink (VSD) – A network of 9 healthcare organizations that conducts vaccine surveillance and research. VSD is also used to figure out if side effects identified using VAERS are actually related to vaccination.
- Clinical Immunization Safety Assessment (CISA) Project -A collaboration between CDC and 7 medical research centers to provide expert consultation on individual cases and conduct clinical research studies about vaccine safety.
There are also systems being developed or expanded to add additional safety monitoring, giving the CDC, FDA, and others the ability to evaluate COVID-19 vaccine safety in real-time and make sure the vaccines are as safe as possible. These are:
- V-SAFE – A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-SAFE will use text messaging and web surveys from CDC to check in with vaccine recipients for health problems following COVID-19 vaccination. The system also will provide telephone follow up to anyone who reports medically significant (important) adverse events.
- National Healthcare Safety Network (NHSN) – An acute care and long-term care facility monitoring system with reporting to VAERS.
- FDA’s Biologics Effectiveness and Safety (BEST) System and FDA’s Sentinel Initiative— Systems that contain administrative and claims-based data for surveillance and research.
- Centers for Medicare and Medicaid Services (CMS) Database – FDA and CMS will collaborate to monitor the CMS database (includes approx. 650K nursing home residents).
- Genesis – National Institute on Aging awarded a grant to a team of researchers based at Brown University to design a monitoring system to identify and track adverse health impacts after nursing home residents receive COVID-19 vaccinations.
If any serious safety issues are detected, immediate action will be taken to find out if the issue is related to the COVID-19 vaccine and determine the best course of action.
Monitoring Vaccine Safety for Veterans
- Department of Veteran Affairs’ (VA) Data Warehouse and Electronic Health Records – A system of electronic health record and administrative data for active surveillance and research
- VA Adverse Drug Event Reporting System (VA ADERS) – A national reporting system for adverse events following receipt of drugs and immunizations
Monitoring Vaccine Safety for Members of the Military
Monitoring Vaccine Safety for Tribal Nations
- Indian Health Service (IHS): IHS VAERS data— Spontaneous adverse event reporting to VAERS for populations served by IHS and Tribal facilities
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