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COVID-19: Pfizer Vaccine EUA, Hospital Reporting Requirements

The Food and Drug Administration (FDA) on Dec. 11 granted an emergency use authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 vaccine in individuals ages 16 and older.

The vaccine, which is administered in two doses three weeks apart, includes a small piece of the SARS-CoV-2 virus’ messenger ribonucleic acid. This triggers human cells to create the virus’ “spike” protein, which in turn triggers the immune system to respond against the virus.

The agency released fact sheets for health care providers and vaccine recipients and their caregivers. FDA’s Vaccine and Related Biological Products Advisory Committee will meet Dec. 17 to consider the Moderna vaccine for the prevention of COVID-19 in individuals age 18 and older. The agency released a briefing document ahead of the meeting.

CDC Vaccine Recommendation, Resources

Following the EUA announcement, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices convened Dec. 12 and issued an interim recommendation for the use of the vaccine. The recommendation is detailed in CDC’s Dec. 13 Morbidity and Mortality Weekly Report.

The agency also released a COVID-19 vaccination communication toolkit to help health care providers educate patients and answer questions about the vaccine. An addendum to the agency’s vaccine storage and handling toolkit outlines storage and handling requirements for the Pfizer vaccine and will be updated with specific information for future vaccines. The agency also released an on-demand online training module for health care providers who will administer vaccines, which includes information about emergency use authorizations, vaccine safety, and storage.

The Centers for Medicare & Medicaid Services (CMS) also has released toolkits for health care providers. CMS also issued Medicare Part B payment codes for the Pfizer COVID-19 vaccine.

HHS Updates Hospital COVID-19 Reporting Requirements

The Department of Health and Human Services (HHS) updated its guidance on COVID-19 data reporting as part of hospital conditions of participation (CoPs) to reflect changes made in a Dec. 2 interim final rule. The new CoPs expand COVID-19 reporting requirements to include current inventory supplies of COVID-19 therapeutics distributed and delivered to the hospital, as well as current usage rate.

Hospitals also must report incidence of acute respiratory illness, including, but not limited to, seasonal influenza virus. The guidance specifies that flu data reporting will be mandatory starting Dec. 18, and therapeutic data reporting will be mandatory starting Jan. 8, 2021.

HHS will hold a webinar on the updated reporting requirements on Dec. 17, at 4 pm ET. The webinar also will include information about automation projects  and Project Greenlight, an interagency initiative to validate health care facility data submitted to HHS. While the webinar will include a question and answer session, attendees also can submit questions to Protect-ServiceDesk@hhs.gov.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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