US FDA, CDC recommend pausing use of Johnson & Johnson vaccine after reports of rare but severe blood clots
Official: EU agency to confirm AstraZeneca blood clot link
ROME (AP) — A top official at the European Medicines Agency says there is a causal link between AstraZeneca's coronavirus vaccine and rare blood clots, but that it's unclear what the connection is and the benefits of taking the vaccine still outweigh the risks of getting COVID-19. Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, told Rome's Il Messaggero newspaper on Tuesday that the EU medicines regulator is preparing to make a more definitive statement on the topic this week.
The Food and Drug Administration and the Centers for Disease Control and PreventionCOVID-19 vaccine after reports of blood clots in individuals who received the vaccine.
The health agencies released a statement Tuesday morning recommending the pause “out of an abundance of caution,” saying blood clots still seem to be “extremely rare.” So far, the CDC and FDA are reviewing six reported cases in the U.S.
All six recipients were women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination, according to the statement. One woman died and one has been hospitalized in critical condition,
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The CDC’s Advisory Committee on Immunization Practices (ACIP) will hold a meeting Wednesday to analyze the cases. The FDA said it will review the committee’s analysis as it also investigates the cases.
“Until that process is complete, we are recommending this pause,” Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a joint statement. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
The type of blood clot reported in individuals who have received the J&J vaccine is called cerebral venous sinus thrombosis (CVST). In most clinical settings, an anticoagulant drug called herapin is usually administered to treat blood clots. However, health officials say using this drug could be dangerous and recommend alternative treatments.
What to Do if You Have an Appointment for the Johnson & Johnson COVID Vaccine
Those who have already made appointments for the J&J vaccine should consider rescheduling options that may be available to them. © Michael M. Santiago/Getty Images A dose of the Johnson & Johnson coronavirus (COVID-19) vaccine is seen on a table at the Northwell Health pop-up coronavirus (COVID-19) vaccination site at the Albanian Islamic Cultural Center in Staten Island on April 08, 2021 in New York City. NYC continues to have a 6.55 percent coronavirus (COVID-19) cases on a seven-day rolling average as the city continues to ramp up vaccinations.
A news conference is scheduled for 10 a.m. As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S. and approximately 9 million more has been shipped out to states, according to the CDC.
“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,” said Schuchat and Marks.
People who have received the J&J vaccine and develop a severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, health officials recommended.
The pause could complicate the country’s vaccination rollout plans, especially after Biden administration moved up the deadline to make all adults eligible for a COVID-19 vaccine from May 1 to April 19.
J&J Blood-Clot Pause Done to Educate Doctors, Monitor Cases
U.S. health officials urged a pause on the use of Johnson & Johnson’s Covid-19 vaccine due to dangerous blood-clotting to give them time to educate doctors on how to treat the exceedingly rare disorder and to “look in all the nooks and crannies” for other cases. That’s the message from Peter Marks, a top official at the U.S. Food and Drug Administration, after six women between the ages of 18 and 48 developed severe blood clots in the brain days after getting the one-shot vaccine and federal officials called for a temporary halt in its use.
The J&J vaccine received emergency use authorization from the FDA in late February.100 million single-shot doses to the U.S. government by the end of May.
Follow Adrianna Rodriguez: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY:
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