The FDA and CDC have called for a pause of the Johnson & Johnson vaccine amid reports of blood clots.
Last month, Johnson & Johnson Janssen vaccine became the third COVID vaccine approved for emergency use in the US. The single-dose vaccine received a stamp of approval by both the US Food and Drug Administration (FDA) and the Center of Disease and Infection Control (CDC). However, on April 13th, both the FDA and CDC announced an immediate pause of the Johnson & Johnson vaccine across the country. The decision came after 6 reported cases of a rare and severe blood clot among the recipients.
According to a joint statement by the FDA and CDC, all 6 cases occurred among women between the ages of 18 to 48 years. Symptoms began within 2 weeks of receiving the vaccine. The rare blood clot seen among them is called cerebral venous sinus thrombosis (CVST). It occurred along with thrombocytopenia – low levels of platelets in the blood. One woman has died, and another is in critical condition because of a blood clot.
Moreover, unlike other blood clots, this one is not treatable by anti-coagulants like heparin. Instead, the use of heparin can cause further damage and even result in death. Therefore, the pause is meant to help health care professionals become more aware of the symptoms of blood clotting and its proper management. Both the FDA and CDC are also currently reviewing the cases further.
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
Joint Statement by CDC and FDA
6 in over 6.8 million
To date, the US has administered more than 6.8 million doses of the Johnson & Johnson vaccine. Only 6 cases of a severe blood clot have come forward out of the millions of doses. A risk that is much less than that associated with the use of birth control pills, or a coronavirus infection. However, experts argue that despite the low risk, the severity of the condition still warrants an investigation. Moreover, the pause will help identify whether there are any more cases.
It isn’t a cancellation, it’s a pause
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases
Last month, the Oxford-AstraZeneca vaccine also caused similar blood-clotting events among vaccinated individuals in Europe. This led to a suspension of the vaccine in several European countries. Both Johnson & Johnson and AstraZeneca use an adenovirus vector for their vaccine. However, it is unclear whether their vaccine technology is the one responsible for the adverse events.
The FDA and CDC are currently asking those who have received the Johnson & Johnson vaccine within 3 weeks to look out for the symptoms of blood clots. These include headache, shortness of breath, leg pain, and abdominal pain.
