April 15, 2021

FDA and CDC Recommend Resuming Use of Johnson & Johnson COVID-19 Vaccine

In mid-April, the FDA and the CDC issued a joint statement on the Johnson & Johnson COVID-19 vaccine, noting that six women experienced rare and severe blood clots after receiving the Johnson & Johnson vaccine.

As of April 12, 2021, more than 6.8 million doses of this specific vaccine have been administered, making the occurrence of these blood clots rare. Out of an abundance of caution, the CDC and the FDA reviewed these cases, recommending a pause in the use of this vaccine.

The type of blood clot that developed across these women is cerebral venous sinus thrombosis (CVST), which was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred in women between the ages of 18 and 49, six to 13 days after vaccination.

Treatment for this specific blood clot is different from typical treatment for blood clots. In most scenarios, an anticoagulant drug called heparin is used to treat blood clots. However, for CVST, heparin may be dangerous, and alternative treatments may be required.

Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the FDA and CDC determined that the use of the Johnson & Johnson COVID-19 vaccine should be resumed. The FDA and CDC are confident that the vaccine is safe and effective in preventing COVID-19.

Current data shows that the vaccine’s known and potential benefits outweigh risks and that the chance of these blood clots occurring is very low.

Individuals who had already received the Johnson & Johnson vaccine who experience severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of getting this vaccine should contact their health care provider.

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