Federal authorities are calling for a temporary halt in the use of the Johnson & Johnson coronavirus vaccine until they assess the risk of the vaccine causing blood clots.
The Food and Drug Administration and the Centers for Disease Control and Prevention issued a joint statement Tuesday morning announcing the pause in giving the vaccine.
“As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine,” the statement said.
The statement said that “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.”
The statement said that treatment for this type of blood clot was different from most clots, and that the standard treatment, involving a drug called heparin, “may be dangerous, and alternative treatments need to be given.”
Until that process is complete, we are recommending this pause. 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.
— U.S. FDA (@US_FDA) April 13, 2021
A CDC committee will meet 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,” the statement said.
The statement noted that so far, very few cases have been reported.
“Right now, these adverse events appear to be extremely rare,” the statement said.
The statement noted that anyone who has developed certain symptoms after getting the Johnson and Johnson vaccine should notify authorities.
“People who have received the J&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,” the statement said.
Last week, several adverse reactions to the Johnson & Johnson vaccine led Colorado authorities to close a mass vaccination site in a Denver suburb.
Johnson & Johnson issued its own statement.
“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine,” the statement said, according to The New York Times.
Janssen is a division of Johnson & Johnson.
Earlier this year, the Astra-Zeneca vaccine, which is widely used in Europe, was put on pause after reports of rare blood clots in a few individuals who had been vaccinated. Officials in Europe have since resumed distributing the vaccine.
Johnson and Johnson, which developed a one-dose vaccine, is one of three vaccines given in the U.S.
Pfizer-BioNTech and Moderna, which are two-dose vaccines, are the major vaccine suppliers with more than 23 million doses a week, The Times reported. Aside from small-scale side effects, no major health concerns have been reported with those vaccines.
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