Saturday, April 24, 2021

U.S. lifts pause on Johnson & Johnson COVID-19 vaccine -

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) announced on Friday they have determined to lift the pause regarding the use of the Johnson & Johnson COVID-19 vaccine, allowing its resumed use for adults.

The decision was made following a thorough safety review, including two meetings of the CDC's Advisory Committee on Immunization Practices (ACIP), said a joint statement of the two agencies.

The pause was recommended on April 13 after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Johnson & Johnson COVID-19 vaccine.

During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body along with thrombocytopenia, or low blood platelet counts, according to the statement.

The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets.

The FDA has determined that 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 FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19," said the statement.

"At this time, the available data suggest that the chance of TTS (thrombosis-thrombocytopenia syndrome) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk," said the statement.

CDC's ACIP advisors met on Friday to discuss the latest data on TTS, and voted to recommend resuming the use of the Johnson & Johnson COVID-19 vaccine for adults.

"We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality," said acting FDA Commissioner Janet Woodcock.

Johnson & Johnson's COVID-19 vaccine was approved for emergency use in the United States in late February. It is the third COVID-19 vaccine that has received FDA's authorization, also the first single dose COVID-19 vaccine available in the United States.

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