Vaccine Adverse Event Reporting System (VAERS) and Safety Monitoring Support for COVID-19 Vaccines

This project will fund a senior physician with Vaccine Adverse Event Reporting Subject Matter expertise to work on adverse neurological and other events associated with COVID-19

vaccinations. Currently there are two FDA-approved COVID-19 vaccines:

• Comirnaty (COVID-19 Vaccine, mRNA)
• Pikevax (COVID-19 Vaccine, mRNA)

See attached solicitation for more information.

There are four COVID-19 vaccines authorized for emergency use in the U.S.:

• Janssen (J&J) COVID-19 Vaccine
• Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent
• Novavax COVID-19 Vaccine, Adjuvanted
• Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

As with all vaccines and other medical products, although the vaccine development process and FDA’s evaluation are rigorous and comprehensive, after a vaccine for COVID-19 is authorized under EUA by FDA, or following licensure (approval) of a BLA, additional pharmacovigilance will be conducted to monitor COVID-19 vaccine safety and effectiveness. Additionally, the senior physician will be tasked with various projects identified by OBPV/DPV to fulfill statutory obligations, user fee commitments, specific Center or Agency goals.