Clotting cases are 'a devastating blow' to J&J vaccine: Dr. Kavita Patel
The Food and Drug Administration said Tuesday it is asking states to temporarily halt using Johnson & Johnson’s Covid-19 vaccine after six people in the U.S. developed a rare blood clotting disorder. Dr. Kavita Patel, fellow at the Brookings Institution, joined "Squawk Box" to discuss the news. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi
The Food and Drug Administration asked states on Tuesday to temporarily halt using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S. developed a rare blood-clotting disorder that left one woman dead and another in critical condition.
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “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.”
All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot. Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.
J&J said in a statement that “no clear causal relationship” has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.
People who got the J&J vaccine more than a month ago are at very low risk for developing the blood clots, Dr. Anne Schuchat, the principal deputy director of the CDC, told reporters on a conference call Tuesday.
“For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breathe you should contact your healthcare provider and seek medical treatment.”
The blood clotting generally occurs about a week after vaccination, but not more than three weeks after, with a median timeframe of 9 days, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said on the call.
“We know that for these vaccines, that for the first several days after vaccination, there are flu-like symptoms that can include headache,” he said, adding that those are likely common adverse events. “It would be more likely if someone presented to an emergency room with very severe headache or blood clots, that a history of vaccination be elicited” and a plan of care put in place. If the patient also has low platelets, doctors should consider that it may be related to the vaccine, he said.
Shares of J&J fell by almost 3% in intraday trading.
The FDA said the pause is expected to last a matter of days.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review the cases, federal health regulators said Tuesday. The FDA is also investigating the cases.
Last week, Europe’s medicines regulator said it found a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford and rare blood-clotting issues. AstraZeneca has not received authorization for use in the U.S.
Emer Cooke, executive director of the European Medicines Agency, said in a televised news conference last week that unusual blood clotting with low blood platelets would be added as a “very rare” side effect to the AstraZeneca vaccine’s product information, along with a slew of other possible adverse reactions.
Isaac Bogoch, an infectious disease specialist who has sat on several drug data and safety monitoring boards, said J&J and AstraZeneca use the same platform for their vaccines. The J&J and AstraZeneca vaccines use an adenovirus, a common type of virus that typically causes mild cold symptoms.
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