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COVID-19: Pfizer Booster Expanded; FDA Authorizes Preventive Monoclonal Antibodies

COVID-19 cases caused by the SARS-CoV-2 omicron variant have been reported in 29 states, the Centers for Disease Control and Prevention (CDC) reports. CDC now recommends booster shots for people as young as 16 years.

“Although we don’t have all the answers on the omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against omicron and other variants,” said CDC Director Rochelle Walensky, MD, MPH.

The Food and Drug Administration Dec. 9 amended its emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to include a booster shot for 16- and 17-year-old individuals at least six months after completing their primary dose series.

While the EUA for the Pfizer primary dose series included individuals 16 and older, the agency previously authorized Pfizer booster shots only for people ages 18 and older. FDA concluded the effectiveness data for individuals 18 and older support extending the eligible booster age population to those as young as 16.

As of Dec. 13, 60.8 percent of Americans are fully vaccinated and 26.6 percent of those fully vaccinated have received a booster dose. A study published Dec. 10 in Morbidity and Mortality Weekly Report shows that, from Aug. 13 to Nov. 19, 44.1 percent of eligible people ages 65 and older received an additional primary dose or booster dose.

CDC Tool Helps Health Care Facilities Plan Vaccination Clinics

CDC’s new COVID-Vac Tool helps health care providers anticipate scheduling needs for and efficiently run large-scale vaccination clinics. The downloadable Excel spreadsheet prompts users to enter staffing availability and clinic arrival rate for a 12-hour shift. Then, it calculates the optimal placement of staff at seven clinic stations and estimates the average and maximum time individuals spend at the vaccination site and the number of individuals at the vaccination site and at each station.

FDA Authorizes Monoclonal Antibodies for Pre-Exposure Prevention

FDA Dec. 8 issued an EUA for AstraZeneca’s Evusheld (the monoclonal antibody tixagevimab co-packaged and administered with cilgavimab) for the pre-exposure prevention of COVID-19 in certain individuals.

The EUA covers adults, as well as children ages 12 and older weighing at least 40 kilograms (about 88 pounds), who are immunocompromised due to a medical condition or immunosuppressive medications or who have a history of severe adverse reactions to COVID-19 vaccines or their components. Individuals must not have been infected with or exposed to SARS-CoV-2.

One dose of Evusheld, administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), might be effective for pre-exposure prevention for six months. In the primary analysis of a double-blind, placebo-controlled clinical trial, Evusheld recipients saw a 77 percent reduced risk of developing COVID-19 compared with those who received a placebo.

FDA released Evusheld fact sheets for health care providers and patients and caregivers.

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 communications manager at America's Essential Hospitals.

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