The New York State Department of Health (DOH) issued an information message (attached) to highlight for providers Food and Drug Administration (FDA) guidance against the use of the SARS-CoV-2 antibody test results to evaluate immunity or protection from COVID-19 after vaccination. The guidance notes that a negative or low result from a SARS-CoV-2 immunoglobulin G antibody test does not indicate insufficient vaccine-induced immunity, and no further doses of COVID-19 vaccine are recommended on the basis of post-vaccination serologic tests for person who have received a complete COVID-19 vaccination series. The FDA guidance aligns with guidance from the Centers for Disease Control and Prevention (CDC).
DOH’s informational message also includes recommendations for assessing COVID-19 immunity, including the following.
- A person is considered fully vaccinated against COVID-19 ≥2 weeks after receipt of the second dose in a two-dose series (Pfizer-BioNTech and Moderna) or ≥2 weeks after receipt of the single-dose Janssen vaccine
- People with a history of prior COVID-19 infection should be offered COVID-19 vaccine regardless of the results of pre-vaccination serologic tests
- People with an incomplete COVID-19 vaccine series (i.e., receipt of a single dose of a two-dose series) should complete the vaccine series as recommended by the CDC regardless of the results of post-vaccination serologic testing
- No additional doses of COVID-19 vaccine are recommended on the basis of post-vaccination serologic test results for people who are fully vaccinated against COVID-19