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| WHO ‘awaiting’ J&J Covid vaccine reviews as US suspension prompts drug maker to delay Europe rollout amid blood clot fears | WHO ‘awaiting’ J&J Covid vaccine reviews as US suspension prompts drug maker to delay Europe rollout amid blood clot fears |
| (5 months later) | |
| The World Health Organization (WHO) has said it is awaiting regulatory reviews of the Janssen Covid-19 vaccine after US health authorities said the jab should be suspended due to rare blood clotting among some recipients. | The World Health Organization (WHO) has said it is awaiting regulatory reviews of the Janssen Covid-19 vaccine after US health authorities said the jab should be suspended due to rare blood clotting among some recipients. |
| “We're watching closely, waiting for EMA (European Medicines Agency) and FDA (U.S. Food and Drug Administration) reviews and monitoring the global database of adverse event reports to see if there have been cases anywhere else,” the WHO said in a statement to Reuters. | “We're watching closely, waiting for EMA (European Medicines Agency) and FDA (U.S. Food and Drug Administration) reviews and monitoring the global database of adverse event reports to see if there have been cases anywhere else,” the WHO said in a statement to Reuters. |
| On Tuesday, the FDA announced the suspension of the Johnson & Johnson's Janssen jab after it reported six cases of cerebral venous sinus thrombosis (CVST), where blood clotting prevents blood draining from the brain. The cases are all in women under the age of 50. | On Tuesday, the FDA announced the suspension of the Johnson & Johnson's Janssen jab after it reported six cases of cerebral venous sinus thrombosis (CVST), where blood clotting prevents blood draining from the brain. The cases are all in women under the age of 50. |
| Over 6.8 million doses of the US-developed vaccine have been administered across the country, the FDA and Centers for Disease Control and Prevention said in a joint statement. | Over 6.8 million doses of the US-developed vaccine have been administered across the country, the FDA and Centers for Disease Control and Prevention said in a joint statement. |
| The health authorities called for the Janssen rollout to be paused “out of an abundance of caution” while further reviews of blood clotting cases take place. | The health authorities called for the Janssen rollout to be paused “out of an abundance of caution” while further reviews of blood clotting cases take place. |
| In response to the US pausing its rollout, J&J announced in a statement that it will “proactively delay the rollout” of its vaccine in Europe, saying that it has been reviewing blood clotting cases with the EMA. | In response to the US pausing its rollout, J&J announced in a statement that it will “proactively delay the rollout” of its vaccine in Europe, saying that it has been reviewing blood clotting cases with the EMA. |
| Other nations have begun to react to the FDA's announcement, including South Africa, which has suspended its use of the Janssen vaccine, despite health services there not receiving any reports of blood clots. | Other nations have begun to react to the FDA's announcement, including South Africa, which has suspended its use of the Janssen vaccine, despite health services there not receiving any reports of blood clots. |
| “We cannot take the decision of the FDA lightly. We've voluntarily suspended the rollout until the causal relationship between the blood clot and the vaccine is sufficiently interrogated,” Health Minister Zweli Mkhize told a news briefing. | “We cannot take the decision of the FDA lightly. We've voluntarily suspended the rollout until the causal relationship between the blood clot and the vaccine is sufficiently interrogated,” Health Minister Zweli Mkhize told a news briefing. |
| Norway's head of infection control at the Institute of Public Health, Line Vold, said J&J's delayed rollout in Europe could cause delays of eight to 12 weeks in Norway, which has also halted its use of AstraZeneca's vaccine. | Norway's head of infection control at the Institute of Public Health, Line Vold, said J&J's delayed rollout in Europe could cause delays of eight to 12 weeks in Norway, which has also halted its use of AstraZeneca's vaccine. |
| Such a delay would be likely to affect the younger cohort of the population more, she added, given higher-risk persons have been prioritized already for vaccination. | Such a delay would be likely to affect the younger cohort of the population more, she added, given higher-risk persons have been prioritized already for vaccination. |
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