Home National FDA Restricts Janssen Covid-19 Vaccine Use Over Blood Clot Risk

FDA Restricts Janssen Covid-19 Vaccine Use Over Blood Clot Risk

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The US Food and Drug Administration (FDA) has restricted the use Janssen a covid-19 vaccine to avoid blood clot risk adding that the vaccine will now only be used in their country for cases where there is no alternative.

After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen Covid-19 vaccine, warrants limiting the authorized use of the vaccine, the FDA said.

The reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered, FDA said. The agency said the benefits of the J&J vaccine outweigh the risks.

According to ministry of health, Uganda has received 15.8 million doses of J&J and the majority was administered in hard-to-reach places.
At least 9.5 million doses of the vaccine for which the government paid Shs37b to acquire, have been dispatched to districts.

Mr Abiaz Rwamwiri, the spokesperson of the Uganda National Drug Authority, when asked if the country is registering such cases of TTS and whether some actions were taken said they are yet to find out.

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