The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention have decided to lift the pause regarding the use of the Johnson & Johnson coronavirus 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 FDA and CDC have confidence that the COVID-19 vaccine is safe and effective in preventing coronavirus. ’
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, the Xinhua news agency reported on Saturday. 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.
"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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"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.
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Source-IANS