COVID-19 News: FDA-CDC statement on J&J vaccine, SYMBIOTICA antibody test, PREPP plan update, Addressing health disparities, OTC and POC Tests
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
CDC and FDA are reviewing data involving six reported U.S. cases, out of 6.8 M doses administered, of a rare and severe type of blood clot in individuals after receiving the J&J vaccine
- Blood clot called cerebral venous sinus thrombosis (CVST) seen in combination with low levels of blood platelets (thrombocytopenia)
- Occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination
- Heparin, commonly used for clots, should not be used this type of clot
Advisory Committee on Immunization Practices (ACIP) on 4/14 to further review these cases and assess potential significance
- Recommending pause in vaccine use out of an abundance of caution
- Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
SYMBIOTICA COVID-19 Self-Collected Antibody Test System
Symbiotica
INDICATION: Qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick blood dried blood spot (DBS) specimens that are self-collected at home by an individual age 18 years or older or
collected by an adult from an individual 5 years of age and older using the COVID-19 Self-Collected Antibody Test System Collection Kit
Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
ADDRESSING UNMET NEED: First prescription use, home collection antibody test. Important in identifying individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection
DESCRIPTION:
- Enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick dried blood spot (DBS) specimens
- COVID-19 Self-Collected Antibody Test System Collection Kit for home collection
- eSTAD ELISA assay used in combination with Calibrator (IgG, Human), Positive control and Negative control
REGULATORY PATHWAY: Emergency Use Authorization
Update on COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative
An independent committee PREPP report identified a number of options for strengthening FDA’s COVID-19 response; five areas have been identified for initial focus
- Improving EUA process
- Timely and accurate information to public
- Further inspectional approaches by using next-gen technologies
- Improve supply chain resilience
Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities
All authorized vaccines tested in clinical trials including participants from racial and ethnic minority, American Indian and Alaska Native, and other diverse communities
- FDA review adheres to rigorous standards for safety and effectiveness
- Working working hand-in-hand with the FDA’s Office of Minority Health and Health Equity (OMHHE) to address concerns about vaccines among diverse communities.
Advancement of Over-the Counter and Other Screening Test Development
Point of Care (POC) testing and Over-the-Counter (OTC) tests important part of pandemic response
- Quidel QuickVue At-Home OTC COVID-19 test – authorized for OTC at-home serial screening
- Abbott BinaxNOW (multiple configurations)
- Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
- Abbott BinaxNOW COVID-19 Ag Card 2 Home Test – authorized for OTC at-home serial screening with telehealth proctor
- Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
- BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription
These authorizations based on efforts to streamline the process for test developers and information to help schools, workplaces, communities, and others establish screening programs.
Image credit: FDA