The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recommended tonight that the pause on the Johnson & Johnson (Janssen) vaccine be lifted and that use of the vaccine can resume. The Department tonight will notify vaccination Points of Dispensing that we are providing them with updated FDA fact sheets for patients and providers and that they may resume administration of the one-dose vaccine.
The action followed the Advisory Committee on Immunization Practices (ACIP) recommendation this afternoon by a vote of 10-4 with one abstention, to resume administration. The federal agencies said they have “confidence that this vaccine is safe and effective in preventing COVID-19.” The FDA “determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.”
The federal agencies said they will continue to monitor adverse event data through the U.S. Vaccine Adverse Event Reporting System (VAERS).
The decision came after the ACIP met for hours today reviewing data involving the cases of individuals who received the J&J vaccine and had adverse reactions. Federal officials recommended a pause in the administration of the Johnson & Johnson vaccine on April 13 out of an abundance of caution. Earlier today, the Department notified vaccination sites to be prepared to resume administration of the Johnson and Johnson vaccine. The FDA has since updated its fact sheets for patients and providers.
This process should demonstrate for the public that the federal vaccine safety monitoring system is strong and should instill confidence in receiving any of the three approved vaccines.
The CDC said this evening that ordering of the Johnson & Johnson vaccine will resume next week.