Government health agencies resume use of Johnson & Johnson’s vaccine

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After an investigation, the CDC and FDA have reaffirmed that the vaccine is safe and effective

Vaccinations with the Johnson & Johnson COVID-19 vaccine have resumed after government health agencies lifted the pause that they had placed on it pending a safety review.

An advisory committee to the Centers for Disease Control and Prevention (CDC) spent about a week reviewing safety data. In particular, the medical experts looked closely at the cases of six women who formed dangerous blood clots within weeks of being vaccinated.

Late Friday, the advisory committee voted to recommend a resumption of Johnson & Johnson vaccinations. Within hours, the CDC and the U.S. Food and Drug Administration (FDA) lifted the pause after determining:

  • The Johnson & Johnson vaccine is safe and effective in presenting COVID-19.

  • The available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

  • The available data suggest that the chance of blood clot formation is very low.

  • Both agencies will continue to investigate the possible risk.

Examined all available data

While the vaccinations were suspended, medical and scientific teams at the FDA and CDC examined available data to assess the risk of the rare but serious blood clot condition called thrombosis, which involves the cerebral venous sinuses, or CVST, and other large blood vessels in the body.

Both agencies also contacted providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these conditions if they occurred in people who have received the Johnson & Johnson vaccine. Vaccinations resumed over the weekend.

“Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walensky. “Our vaccine safety systems are working.”

‘Exceptionally rare events’

Walensky said the two health agencies identified what she called “exceptionally rare events,” noting that the small number of reactions occurred out of millions of doses administered.

"As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere,” said Paul Stoffels, Johnson & Johnson’s chief scientific officer.

The company has also updated the emergency use authorization (EUA) fact sheets for health care providers administering the vaccine. The update includes information about the diagnosis and treatment of blood clot conditions. 

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