Emergency COVID-19 Vaccine Review Meeting Scheduled for April 14th

A joint media briefing conducted by three leaders from the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) was held at 10 a.m. ET on April 13, 2021, discussing the 'pause- recommendation' for the experimental Johnson & Johnson - Janssen COVID-19 Vaccine.

Held on the FDA’s YouTube page, this emergency media briefing was led by Dr. Janet Woodcock, acting FDA Commissioner, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, and Anne Schuchat, M.D., principal deputy director, CDC.

During this digital session, various questions were submitted by the media to these leaders. Each response was reasoned and appropriate, given the nature of the six cases related to Thrombotic Thrombocytopenia and life-threatening pulmonary embolism and other emboli after receiving a Janssen COVID-19 vaccination.

Since authorized by the FDA in March 2021, the Janssen vaccines have been administered about six million times.

The primary action plan focuses on an emergency meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), scheduled for April 14, 2021, from 1:30 p.m. to 4:00 p.m. ET. No registration is required to attend this open-to-the-public virtual ACIP meeting.

UPDATE: draft agenda posted for this ACIP meeting.

Additionally, the FDA and CDC teams are in contact with the European Medicines Agency, which launched its review of the Janssen COVID-19 Vaccine on April 9, 2021.

Regarding the vaccine risk-benefit debate, the Winton Center at the University of Cambridge recently offered this statement: 'All medical treatments have potential harms as well as potential benefits, and it's important to be able to weigh these against each other.'

'With vaccines, the benefits are particularly complex as they can involve benefits to others as well as to ourselves - and the harms can feel particularly acute because we take vaccines when we are healthy, as a preventative measure.'