Vaccination Update
Guidance was issued at the end of the State Public Health Emergency (PHE) clarifying that New York State Immunization Information System (NYSIIS) and Citywide Immunization Registry (CIR) reporting of vaccination administration within 24 hours is still required of entities providing vaccinations under the State and City vaccination programs. The guidance is available here.
The State also issued updated guidance for COVID-19 State Vaccination Program providers on June 24th. The document includes two new sections of interest to members:
Shelf Life Extended for J&J Vaccine
On June 10th, the Food and Drug Administration (FDA) authorized an extension of the shelf life of the Johnson & Johnson (J&J)/Janssen single-shot COVID-19 vaccine from 3 months to 4.5 months (an additional 6 weeks). The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).
Vaccine providers that have J&J vaccine in storage should visit the Janssen COVID-19 Vaccine Product Quality Checker and enter the lot number to confirm the latest expiration dates of vaccine, including those currently available for administration throughout the U.S. This extension applies to refrigerated vials of J&J vaccine that have been held in accordance with the manufacturer’s storage conditions. The vials and carton must be marked with the new date displayed, and the date must also be updated in the NYSIIS or CIR inventory module.
If providers have vaccine in storage that expired prior to June 10th, those vials should be disposed of as medical waste and reported as wastage in NYSIIS/CIR (see NYSIIS wastage reporting guidance here and CIR guidance here). COVID-19 vaccines that are authorized under an emergency use authorization (EUA) do not have fixed expiration dates, and their expiration dates may be extended as the FDA receives and reviews additional stability data.
Vaccine providers should check the manufacturer’s website to obtain the most up-to-date expiration dates for COVID-19 vaccines they have on hand.
Special Considerations for Individuals Receiving COVID-19 Vaccine Outside the United States
The Centers for Disease Control and Prevention (CDC) guidance for fully vaccinated people states that “this [CDC] guidance can also be applied to COVID-19 vaccines that have been authorized for emergency use by the World Health Organization (WHO) (e.g., AstraZeneca/Oxford).”
For COVID-19 vaccines not authorized by the FDA, but listed for emergency use by the WHO:
- People who have received all recommended doses of a COVID-19 vaccine that is listed for emergency use by the WHO do not need any additional doses with an FDA-authorized COVID-19 vaccine.
- People who have not received all the recommended doses of a COVID-19 vaccine listed for emergency use by the WHO may be offered a complete FDA-authorized COVID-19 vaccine series.
For COVID-19 vaccines neither authorized by the FDA nor listed for emergency use by the WHO:
- People who received all or some of the recommended doses of a COVID-19 vaccine that is neither authorized by the FDA nor listed for emergency use by the WHO may be offered a complete FDA-authorized COVID-19 vaccine series.
COVID-19 Vaccines Listed for Emergency Use by the WHO:
As of June 15th, the WHO has listed the following COVID-19 vaccines for emergency use:
- Pfizer-BioNTech COVID-19 vaccines (e.g., COMIRNATY, Tozinameran)*
- J&J/Janssen COVID-19 vaccine*
- Moderna COVID-19 vaccine*
- AstraZeneca-Oxford COVID-19 vaccines (e.g., Covishield, Vaxzevria)
- Sinopharm COVID-19 vaccine
- Sinovac COVID-19 vaccine
*Also authorized by the FDA for emergency use in the United States
Contact: Meg Everett, meverett@leadingageny.org, 518-929-9342