USFDA, CDC announce Johnson & Johnson Covid-19 vaccine to administer for adults

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

The temporary suspension  Johnson & Johnson Covid-19 vaccine was recommended on April 13 after reports of six cases of a rare and severe type of blood clot in individuals happened.

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 recognise 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.

 

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