On Tuesday morning, the Biden administration called for a ‘pause’ in the administration of the Johnson and Johnson COVID-19 China coronavirus vaccine. The FDA and CDC have asked states to ‘pause’ the J&J vaccine while the issue is investigated, citing six cases of blood clots in women aged 18-48–including one fatality–out of around seven million vaccines administered.
AstraZeneca’s similar vaccine, which was also used in Europe, had similar clotting problems. The ‘pause’ was first reported by the New York Times.
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Breaking News: The U.S. will seek to pause Johnson & Johnson’s coronavirus vaccine after six women developed rare blood clots, officials briefed on the decision said.https://t.co/9cnE2E0Ehn
— The New York Times (@nytimes) April 13, 2021
Dr. Anne Schuchat, Principal Deputy Director of the CDC, and Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, are quoted in the following statement.
More than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the United States as of April 12. The CDC and FDA are reviewing data involving six confirmed cases of a rare and serious form of blood clot in people who received the J&J vaccine in the United States. A type of blood clot known as cerebral venous sinus thrombosis (CVST) was seen in these cases, along with low blood platelet levels (thrombocytopenia).
Symptoms appeared 6 to 13 days after vaccination in all six cases, which occurred in women aged 18 to 48. This form of blood clot needs a different treatment than other types of clots. Blood clots are usually treated with heparin, an anticoagulant medication. Heparin administration can be harmful in this situation, and alternative therapies must be provided.
The Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to further examine these cases and determine their possible relevance, according to the CDC. The FDA will look at the analysis as part of its investigation into these cases.
Out of an abundance of caution, we suggest a pause in the use of this vaccine until that phase is complete. This is critical in part to ensure that the health-care system is aware of the risk of these adverse effects and can prepare for adequate recognition and management as a result of the particular treatment needed for this form of blood clot.
These side effects tend to be exceedingly rare at the moment. The federal government places a high emphasis on COVID-19 vaccine protection, and we take all reports of health issues following COVID-19 vaccination very seriously.
Within three weeks after receiving the J&J vaccine, people who experience extreme headaches, stomach pain, leg pain, or shortness of breath should contact their health care provider. Adverse effects should be reported to the Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html. external symbol
At a press conference later today, the CDC and FDA will provide further details and address questions. The FDA’s YouTube channel will have a video of the press conference.