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COVID-19: Eli Lilly EUA, Pfizer Vaccine Analysis

The Food and Drug Administration (FDA) on Nov. 9 granted emergency use authorization (EUA) for Eli Lilly’s investigational neutralizing antibody, bamlanivimab (LY-CoV555), to treat COVID-19.

The antibody imitates the immune system’s attack on the virus. Under the EUA, the antibody may be used to treat mild to moderate COVID-19 in nonhospitalized adults, as well as pediatric patients who are 12 years and older and weigh more than 88 pounds, who are at high risk of progressing to severe COVID-19 or hospitalization.

Under Operation Warp Speed, the federal government will purchase 300,000 doses of bamlanivimab in November and December. The government also has the option to purchase up to 650,000 vials of the treatment through June 30, 2021.

Allocations will be made in two phases. During phase one, states and territories will allocate the product to hospitals and hospital-affiliated locations. Phase two will include expanded distribution to additional outpatient facilities, based on further assessment of drug administration requirements.

The Department of Health and Human Services (HHS) prepares to allocate and distribute more than 80,000 doses this week. HHS will update its allocation dashboard each week.

FDA issued fact sheets for health care providers and patients and caregivers, along with FAQs about the EUA. The agency also released a full Lilly Bamlanivimab Antibody Playbook.

Operation Warp Speed also updated its monoclonal antibody playbook to reflect the recent EUA.

Pfizer Releases Promising Vaccine Study Results

Pfizer and BioNTech announced promising results from the first interim efficacy analysis of their COVID-19 vaccine candidate. The two-dose, mRNA-based vaccine has an efficacy rate of more than 90 percent seven days after the second dose.

The study enrolled 43,538 participants, 42 percent of whom had racially and ethnically diverse backgrounds. Pfizer and BioNTech will not file for an EUA until half of the patients in the study have been observed for safety issues for at least two months after their second dose, which is expected the third week of November.

CDC Updates Recommendations for Health Care Personnel

The Centers for Disease Control and Prevention (CDC) on Nov. 4 updated its infection prevention and control recommendations for health care personnel. The new recommendations include different options for screening individuals before they enter a health care facility, including the implementation of an electronic monitoring system through which people can report before arriving at the facility:

  • absence of fever and symptoms of COVID-19;
  • absence of a diagnosis of SARS-CoV-2 infection in the prior 10 days; and
  • no exposure to others with SARS-CoV-2 infection during the prior 14 days.

The guidance also includes a summary of factors that can affect temperature readings, including the ambient environment in which the temperature is measured, thermometer calibration, and proper thermometer usage and reading. The agency notes that holding non-contact infrared thermometers too close or too far from the temporal artery in the forehead can affect the temperature reading.

Additionally, CDC added resources for evaluating and managing ventilation systems in health care facilities, and FAQs about the use of personal protective equipment.

NIH Study: Hydroxychloroquine Does Not Benefit Adults with COVID-19

A National Institutes of Health study published Nov. 9 in the Journal of the American Medical Association shows that hydroxychloroquine has no clinical benefit to hospitalized patients with COVID-19. Launched in April at 34 hospitals nationwide, the trial enrolled 479 of an expected 510 patients, half of whom received 10 doses of hydroxychloroquine and half of whom received a placebo. At day 14, patients who received hydroxychloroquine and patients who received a placebo had a similar health status, and the number of patients in each group who died was similar. The study stopped in June.

Biden-Harris Transition Team Names COVID-19 Advisory Board

President-elect Joe Biden and Vice President–elect Kamala Harris named 13 members to their COVID-19 advisory board, which will advise the new administration’s pandemic response.

The advisory board is co-chaired by David Kessler, MD, professor of pediatrics and epidemiology and biostatistics at association member University of California San Francisco (UCSF), along with Vivek Murthy, MD, MBA, former U.S. surgeon general, and Marcella Nunez-Smith, MD, MHS, associate professor of internal medicine, public health, and management at Yale University and the associate dean for health equity research at the Yale School of Medicine.

The board includes two additional representatives from association member UCSF’s School of Medicine: Robert Rodriguez, MD, professor of emergency medicine, and Eric Goosby, MD, professor of medicine.

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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