The Food and Drug Administration (FDA) expressed the government’s commitment to transparency in vaccine and therapeutic developments to ensure public confidence in the system and any resulting drugs or products, specifically related to COVID-19 vaccines.
In a statement, FDA Commissioner Stephen Hahn, MD, explained that drug and biological product centers will publicly post reviews of the scientific data and information supporting the issuance, revision, or revocation of emergency use authorizations (EUAs) for all drug and biological products, including vaccines, as part of the agency’s COVID-19 response.
The Government Accountability Office (GAO) also released a report acknowledging more transparency is needed for EUAs. In a study, GAO reviewed federal laws and agency documents, including departments of Health and Human Services and Defense information on vaccine and therapeutic development and EUAs as of November. GAO recommends that FDA identify ways to uniformly disclose to the public information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines.
FDA Authorizes Monoclonal Antibody
On Nov. 21, FDA issued an EUA for two monoclonal antibodies to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients. In clinical trials, the monoclonal antibodies were shown to reduce hospitalizations and emergency department visits for patients with COVID-19. Fact sheets are available for health care providers and patients and caregivers, including dosing instructions, potential side effects, and drug interactions.
COVID-19 Vaccine Updates
Primary data in vaccine trials with AstraZeneca show the vaccine was highly effective in preventing COVID-19. On average, the vaccine had a 70 percent efficacy rate with up to a 90 percent potential efficacy rate based on dosing regimens examined.
On Dec. 10, FDA’s Vaccines and Related Biological Products Advisory Committee will meet to discuss the request for an EUA of a Pfizer COVID-19 vaccine. FDA will make background information available, as well as provide an agenda and committee roster to the public before the meeting.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.