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New COVID-19 Vaccine Approved for Use

Posted Sep 19, 20233 min Read

Regulatory & Clinical
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On September 11, the U.S. Food and Drug Administration (FDA) approved for emergency use updated COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. These new vaccines are formulated to target current,​ more closely circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.

On September 12, the Center for Disease Prevention and Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) met to provide review the evidence and provide recommendations regarding use of these approved vaccines. The CDC recommends that if you have not received a COVID-19 vaccine in the past 2 months, to get the newly updated COVID-19 vaccine.

The newly approved COVID-19 vaccine has several important implications for long term care providers, as follows:

  • Facilitate Vaccinations for Residents and Staff
    • Long term care residents are at the greatest risk of serious illness, hospitalization and death from COVID-19. Providers must prioritize resident and staff vaccination for COVID-19, as well as flu and RSV.
    • AHCA has developed a comprehensive vaccine toolkit that includes a vaccination checklist providing best practices on getting residents vaccinated for all three respiratory viruses this fall.
    • In accordance with CDC’s General Best Practice Guidelines for Immunization, routine administration of all age-appropriate doses of vaccines simultaneously is recommended if there are no contraindications at the time of the healthcare visit
  • Change to NHSN “Up to Date” Definition
    • The NHSN surveillance definition of “up-to-date” will change with the release of this new vaccine. This will impact NHSN reporting and publicly reported vaccination rates.
    • This means that as of 9/25, most residents will not be up to date. This is expected by CDC and other public health officials.
    • NHSN is hosting four upcoming trainings to discuss these changes. Providers should register for one of the training dates offered.
  • SNF QRP Reporting
    • As a reminder, skilled nursing facilities are also required to report their weekly Healthcare Personnel COVID-19 Vaccination Summary data as part of the SNF QRP Reporting program.
    • The SNF QRP measure is a process measure and is not risk-adjusted. Therefore, it is only a pay-for-reporting measure. No QRP penalties will be issued based on rates of staff vaccine uptake, but percentages of staff uptake will be published on Care Compare.
  • Bivalent COVID-19 Vaccine No Longer Approved
    • Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States with the approval of the new COVID-19 vaccines.