Moderna on Nov. 30 applied for emergency use authorization (EUA) and conditional approval from the Food and Drug Administration (FDA) and European Medicines Agency. The primary efficacy analysis showed that the messenger RNA vaccine had a 94.1 percent efficacy rate against COVID-19.
FDA’s Vaccines and Related Biological Products Advisory Committee plans to meet Dec. 17 to review the vaccine’s safety and efficacy data package. An independent Data Safety Monitoring Board, appointed by the National Institutes of Health, continues to monitor safety data.
CDC ACIP Issues Ethical Vaccine Allocation Principles
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) on Nov. 27 published four ethical principles to guide allocation of the COVID-19 vaccine:
- maximize benefits and minimizing harms;
- promote justice;
- mitigate health inequities; and
- promote transparency.
The committee identified four initial groups to receive the vaccine: health care workers, other essential workers, adults with high-risk medical conditions, and adults ages 65 and older.
The latest Morbidity and Mortality Weekly Report describes how the agency plans to apply each ethical principle in allocating vaccines to each of the four groups.
CDC’s Immunization Action Coalition will host a Dec. 3 webinar from 1–2 pm ET on vaccine implementation.
CDC, FDA Update Mask Guidance
CDC updated strategies for optimizing the supply of face masks in health care settings. The guidelines include strategies for operating at three capacity levels:
- conventional capacity: measures that should already be implemented in general infection prevention and control plans;
- contingency capacity: temporary measures that should be used during periods of expected face mask shortage; and
- crisis capacity: strategies that do not meet standards of care but may need to be adopted during periods of known face mask shortage.
The updated strategies include recommendations for transitioning from contingency to conventional capacity, as well as clarifications on re-using masks and wearing masks for multiple patient encounters.
FDA also updated its frequently asked questions on face mask use, which includes information about reporting mask shortages to the agency.
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.