Pfizer and BioNTech have asked the Food and Drug Administration (FDA) to delay its review of the companies’ request to amend the emergency use authorization (EUA) for their COVID-19 vaccine to include children ages six months to four years.
The companies initially tested a series of two three-microgram doses but announced in December 2021 plans to amend the study to test a third dose. Pfizer and BioNTech initially filed for authorization of the first two three-microgram doses in a planned three-dose primary series, but, noting the fast pace of the study, chose to delay review until data from all three doses are available.
The companies anticipate data from all three doses will be available in early April. Following the companies’ request, FDA postponed its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15.
“Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered,” wrote Acting FDA Commissioner Janet Woodcock, MD, and Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a joint statement.
The Centers for Disease Control and Prevention (CDC) updated its Pediatric COVID-19 Vaccination Operational Planning Guide with information about vaccinating children six months to four years old. CDC anticipates a sequenced rollout of an initial 10 million doses; shipment will begin once FDA issues an EUA, but vaccination administration can only begin following the CDC recommendation. The guide also includes considerations for determining sites to receive initial doses and a pediatric readiness checklist. Additional resources are available on CDC’s COVID-19 Vaccination for Children webpage.
FDA Issues Monoclonal Antibody EUA
FDA on Feb. 11 issued an EUA to Eli Lilly and Co. for bebtelovimab, a monoclonal antibody product. Bebtelovimab is authorized to treat mild to moderate COVID-19 in adults and pediatric patients ages 12 and older who weigh at least 40 kilograms and are at high risk for progression to severe COVID-19.
Like other monoclonal antibodies, bebtelovimab functions by binding to the spike protein of SARS-CoV-2, the virus that causes COVID-19. In a randomized, phase 2 clinical trial that evaluated the use of bebtelovimab alone and with other monoclonal antibodies to treat COVID-19, treatment with bebtelovimab resulted in reduced time to sustained symptom resolution compared with a placebo. Reduction in viral load relative to placebo was also seen on day 5 after treatment.
Among high-risk patients, rates of COVID-19 hospitalization and death through day 29 were lower in those who received bebtelovimab alone or with other monoclonal antibodies than the placebo rate reported in previous trials of other monoclonal antibodies in high-risk patients. Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. FDA has released fact sheets for health care providers and patients and caregivers on the treatment.
The federal government has purchased 600,000 treatment courses of bebtelovimab. The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response has prepared 50,000 courses for distribution on Feb. 14, in addition to a scheduled distribution of 52,250 doses of sotrovimab. Orders may be placed through the Health Partner Ordering Portal.
For questions about COVID-19 therapeutics distribution, email COVID19Therapeutics@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 firstname.lastname@example.org or 202.585.0127 with questions.