14 April 2021 - - On April 13 the The United States Centers for Disease Control (CDC) and the US Food and Drug Administration (FDA) issued joint statements regarding the safety of US-based healthcare company Johnson and Johnson's (NYSE: JNJ) (Janssen) COVID-19 vaccine. The agencies have recommended a pause in the use of this vaccine.

A joint statement put out Tuesday evening is attributed to Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC

As of April 12, more than 6.8m doses of the Johnson and Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J and J vaccine.

In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered.

Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance.

FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.

This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.
People who have received the J and J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

For its part, Johnson and Johnson said that, in addition to cooperating with US authorities, it have been reviewing these cases with European health authorities. Johnson and Johnson has made the decision to proactively delay the rollout of its vaccine in Europe and has paused vaccinations in all Janssen COVID-19 vaccine clinical trials while it updates guidance for investigators and participants.
Johnson said it continues to expect to deliver its COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.