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NYSHFA News May 23, 2022

Important COVID Vaccination Program Guidance: UPDATED clinical guidance, screening checklists, and consent forms – May 21, 2022

Recommendations and eligibility for COVID-19 vaccination are expected to be updated repeatedly in coming months and potentially years. As NYS clinical guidance is aligned with CDC clinical guidance, the format of NYS guidance documents are being updated to refer providers to CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for clinical guidance. The attached Guidance for the New York State COVID-19 Vaccination Program: Vaccination of Children Ages 5-11 has been updated in this new format. It retains a list of recent changes, key points, sections with NYS-specific information, sections for certain special situations, and sections or links with important information that is not included in CDC’s clinical considerations document (e.g., storage and handling). The Guidance for the New York State COVID-19 Vaccination Program for Individuals 12 Years of Age and Older will also be updated in the coming week to reflect the new format.

NYS clinicians are encouraged to read and become thoroughly familiar with the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, which is the best source for both general guidance and guidance for special situations.  

A summary of the most recent changes to the Guidance for the New York State COVID-19 Vaccination Program: Vaccination of Children Ages 5-11 is outlined below:

  • The CDC recommends a single Pfizer-BioNTech COVID-19 vaccine booster dose for person ages 5-11 years who are NOT moderately to severely immunocompromised at least 5 months after the primary series under the FDA’s EUA. 
  • The CDC recommends a single Pfizer-BioNTech COVID-19 vaccine booster dose for person ages 5-11 years who ARE moderately to severely immunocompromised at least 3 months after the primary series under the FDA’s EUA. 
  • CDC clinical considerations were amended to provide considerations for people who recently had SARS-CoV-2 infection to delay their primary series or booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic).  
  • Storage and handling requirements, including temperature monitoring and temperature excursion reporting requirements for COVID-19 vaccination providers have been outlined. 
  • The FDA has approved an amendment to the EUA for Pfizer Pediatric Vaccine (orange cap for ages 5 through 11, with diluent), extending the shelf life of the Pfizer product formulation from 9 to 12 months. 
  • The CDC has updated considerations for COVID-19 revaccination for patients who received one or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab) that were administered over a limited period of time.  
  • Updates were made regarding the considerations to initiate COVID-19 vaccination in children with a history of multisystem inflammatory syndrome in children (MIS-C). 
  • Updates were made regarding individuals who were vaccinated outside the US and individuals who were vaccinated as part of a clinical trial. 
  • The link to NYS Wastage Guidance has been updated to reflect updated guidance. 
  • The link to Redistribution Guidance has been updated to reflect updated guidance. 

Attached are updated documents:

Thank you for your ongoing participation in the COVID-19 Vaccination Program.

Sincerely,

The NYS COVID-19 Vaccine Team

Posted in Clinical & Quality
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