'We know the information we are providing today will be very concerning to many people who already received the Johnson and Johnson vaccine,' explained Janet Woodcock, M.D., acting FDA commissioner. Marks said the pause is in part to make sure all healthcare providers are aware this can be an issue and to be alert if a patient presents with clots and low platelets and not to treat them with heparin and recognize this might be related to a vaccine. However, there are concerns that there could be more cases of CVST blood clots seen in combination with thrombocytopenia that might not have been connected yet to the vaccine, or patients may still present to hospitals or their primary physician with symptoms up to three week after getting the Janssen vaccine. Healthcare Workers Need to Recognize CVST and Low Platelets as Possible Side Effect of Janssen Vaccine It is available for use in the U.S for use in individuals 18 years of age and older. The FDA issued an emergency use authorization (EUA) for the Janssen Biotech COVID-19 Vaccine, the third vaccine for the prevention of coronavirus, Feb. 'Healthcare providers who see people who are presenting with blood clots and have low blood platelets should assess if the patient has received a COVID vaccine.'Īs of April 12, the FDA said more than 6.8 million doses of the Janssen vaccine have been administered in the U.S. 'Right now these events appear to be extremely rare,' Marks said in the press conference. Overall, the experts say the Janssen vaccine is very safe, with only 6 known cases of this severe adverse event out nearly 7 million doses of the Janssen vaccine administered so far. Janssen Vaccine Appears to be Safe in Vast Majority of Patients The CDC and FDA held a press briefing today and a recording will be available on the FDA’s YouTube channel. Healthcare providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at. 'We take all reports of adverse events following vaccination very seriously,' Marks said. 'Healthcare providers who see people presenting to them with either a low platelet count or blood clots should establish whether or not the individual has been recently vaccinated in order to inform the proper diagnostic evaluation and management.' However, Marks explained COVID-19 vaccine safety is a top priority for the federal government. He said right now, these adverse events appear to be extremely rare. 'This is important, in part, to ensure that the healthcare 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.' 'Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,' said Peter Marks M.D., Ph.D., director of the FDA Center for Biologics Evaluation and Research (CBER). FDA will review that analysis as it also investigates these cases. Usually, the anticoagulant heparin is used to treat blood clots, but in this setting, administration of heparin can be dangerous and alternative treatments need to be given.ĬDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, to further review these cases and assess their potential significance. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. In a joint statement from the CDC and FDA, they said there were six cases cerebral venous sinus thrombosis (CVST) blood clots seen in combination with low levels of blood platelets (thrombocytopenia). One patient has died from the complication and one remains in critical condition. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are calling for a pause in using the Johnson & Johnson/Janssen COVID-19 (SARS-CoV-2) vaccine today after several reports of a rare, severe, stroke-like type of blood clot in patients after receiving the J&J vaccine. (This story was updated in the last subheaded section)ĪpThe U.S.

Fda pauses johnson and johnson