FDA panel recommends EUA for Johnson & Johnson COVID-19 vaccine candidate
The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee today recommended the approval of Johnson & Johnson’s COVID-19 vaccine candidate. The panel voted unanimously to recommend that FDA issue an emergency use authorization for the candidate, which is administered as a single dose.
Once FDA authorizes the candidate’s emergency use, Johnson & Johnson will turn doses over the Federal Emergency Management Agency’s contractor, McKesson, for shipment with administration kits. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is also scheduled to meet over the weekend to determine if limits should be placed on those who would receive the Johnson & Johnson vaccine.
AHA members will receive a Special Bulletin with details on the vaccine’s administration and storage, along with other important details, following FDA’s decision.