“Out of Abundance of Caution” Johnson & Johnson COVID-19 Vaccine is Paused

Leadership From the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) spoke to members of the press this morning to explain their rationale for recommending a pause in the administration of the Johnson & Johnson COVID-19 vaccine.

Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, Janet Woodcock, MD, acting FDA commissioner, and Anne Schuchat, MD, principal deputy director, CDC were all in attendance to present information and answer questions from the media.

Schuchat acknowledged the serious nature of the news they were delivering. “I know the information we are providing today is going to be very concerning to Americans who’ve already received the Johnson & Johnson, or Janssen vaccine, and I want to let you know to what we are doing to learn more and protect people in the meantime.”

All three said these cases were “extremely rare”, with 6 cases of blood clots, including 1 fatality and 1 person in critical condition, after more than 6 million doses had been administered. All patients presented with cerebral venous sinus thrombosis (CVST) in combination with low-levels of platelets in the blood (thrombocytopenia) in women ages 18-48 who presented with symptoms 6-13 days after vaccine administration.

Treatment is different for CVST compared to other blood clots, Marks said.

“While we review the available data, out of an abundance of caution, the FDA and CDC are recommending a pause in the use of this vaccine in the United States,” Marks stated. “…COVID-19 vaccine safety is a top priority for the federal government and we take all reports of adverse events following vaccination very seriously. Health care providers who see people presenting to them with either a low blood platelet count or blood clots should establish whether or not the individual has recently been vaccinated in order to inform the appropriate diagnostic evaluation and management.”

Marks said no known cases of CVST combined with thrombocytopenia were seen in the m-RNA vaccines.

Marks and Woodcock remarked on the potential cause. While they both said the definitive cause was not known they had theories around the platform. “Immune response, potentially” with activation of blood clots and platelets Woodcock said.

They announced the CDC was going to hold a public Advisory Committee Immunization Practices (ACIP) meeting tomorrow to review the Johnson & Johnson COVID-19 data and these adverse events. “One of the things the ACIP deliberation will do is review the data on the cases and the context of risks, benefits,” Schuchat stated.

Woodcock remarked she believed it would be a “matter of days for this pause” in knowing the cause.