FDA Urges Pause of J&J COVID Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The FDA and CDC has recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies announced Tuesday.

In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to review the cases.

“This is important to ensure that the health care provider community is aware of the potential for these adverse effects and can plan due to the unique treatment required with this type of blood clot,” the FDA said on Twitter.

Johnson & Johnson in a statement said, “We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.”

The company said they are also reviewing these cases with European regulators and “we have made the decision to proactively delay the rollout of our vaccine in Europe.”

This is a developing story, please check back for continuing coverage.

Source: Read Full Article