SOLICITATION NOTICE
B -- Vaccine Adverse Event Reporting System (VAERS) and Safety Monitoring Support for COVID-19 Vaccines
- Notice Date
- 4/18/2023 8:20:35 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- FDA-RFP-116785
- Response Due
- 4/25/2023 1:30:00 PM
- Archive Date
- 04/26/2023
- Point of Contact
- Paige Eyberg
- E-Mail Address
-
paige.eyberg@fda.hhs.gov
(paige.eyberg@fda.hhs.gov)
- Small Business Set-Aside
- 8A 8(a) Set-Aside (FAR 19.8)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/be8fbe21ffd54f0c8eb944a8149580ad/view)
- Record
- SN06653969-F 20230420/230418230121 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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