The Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee on Sept. 17 voted 16–2 against administration of a third or “booster” dose of the Pfizer-BioNTech COVID-19 vaccine, to all individuals age 16 and older.
However, the committee voted unanimously in favor of recommending a booster dose to people age 65 and older and people at high risk of severe illness from COVID-19. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to clarify who qualifies as high risk. ACIP will meet virtually Sept. 22, from 10 am—5 pm ET, and Sept. 23, from 11 am—2 pm ET.
CDC Announces More Than $2B for Infection Prevention and Control
CDC on Sept. 17 announced $2.1 billion in American Rescue Plan Act funding will be dedicated to improving infection prevention and control in health care facilities, citing a rise in health care–associated infections during the COVID-19 pandemic.
This allotment includes $1.25 billion administered to 64 state, local, and territorial health departments, over three years. Of that, $885 million will be distributed through initial awards in October 2021, including:
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- $500 million to support strike teams at state-based nursing homes, skilled nursing facilities, and long-term care facilities experiencing COVID-19 outbreaks; and
- $385 million to support state capacity to address infectious disease threats across health care settings; health care laboratory capacity; Project Firstline, a CDC program to educate health care workers about infection control; National Healthcare Safety Network data collection and monitoring; and antibiotic stewardship initiatives.
The overall allotment also includes $880 million over several years to support infection prevention, training, data collection, and technical assistance efforts from health care partners, academic institutions, and other nonprofit partners.
About $365 million is designated for future years.
FDA Revises Monoclonal Antibody EUA
FDA also revised its emergency use authorization of bamlanivimab and etesevimab, administered together, to include post-exposure prophylaxis (prevention) for COVID-19 in patients ages 12 and older and weighing at least 40 kilograms, who are:
- at high risk for severe illness, including hospitalization or death; or
- not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination due to immunocompromise and have been exposed to an individual with coronavirus or are at high risk of exposure in an institutional setting, such as a nursing home or prison.
The monoclonal antibody combination also remains authorized to treat mild to moderate COVID-19 in adults and pediatric patients (ages 12 and older, weighing at least 40 kg) who test positive for SARS-CoV-2 and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The Department of Health and Human Services’ assistant secretary for preparedness and response previously paused distribution of these therapeutics after tests showed the combination of drugs was ineffective against P.1 (gamma) or B.1.351 (beta) variants of COVID-19.
CDC Webinar on National Healthcare Safety Network COVID-19 Vaccination Module
CDC will hold a Sept. 22 webinar, from 1–2 pm ET, on upcoming changes to the weekly National Healthcare Safety Network COVID-19 Vaccination Data Collection Form for non–long-term care facilities.
The webinar will discuss new data reporting categories, the monthly reporting plan, and how to report additional or booster vaccine doses.
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.
