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J&J jabs expected to resume this week


J&J jabs expected to resume this week
By Claire Keeton - 19 April 2021
The pause in the rollout of Johnson & Johnson s Covid-19 vaccine to investigate a very rare blood clotting disorder is likely to be lifted soon. File photo.
Image: Dado Ruvic/Reuters
Prof Glenda Gray, co-principal investigator of the Sisonke implementation study, which is providing health-care workers with Covid-19 J&J vaccines, said on Monday morning the suspension of the inoculations is expected to be lifted soon.
The vaccinations were paused by the SA Health Products Regulatory Authority (Sahpra) on Tuesday night last week, the same day the US Food and Drug Administration paused its J&J rollout because of extremely rare and severe blood clots detected in six out of 6.8 million Americans vaccinated. ....

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Q&A with Sahpra chairperson Helen Rees on J&J vaccine pause


Q&A with Sahpra chairperson Helen Rees on J&J vaccine pause
The South African Health Products Regulatory Authority suspended authorisation of the J&J vaccine being used on health-care workers in the Sisonke trial after the US Food and Drug Administration said six women out of more than 7-million people vaccinated developed blood clots. Chris Barron asked professor Helen Rees, chair of Sahpra .
18 April 2021 - 00:00 By Chris Barron
Why suspend on the back of such minuscule numbers?
In fact, it wasn t suspended, it was paused. The decision to pause and find out more about this and check whether there s anything showing up in our own database from the nearly 300,000 health-care workers that could possibly be like this came initially from the ethics committees. That s what they re there for. To protect individual participants in the trial. We do need to look into this and see whether we can continue. ....

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Sahpra lifts suspension on J&J vaccines with 'conditions'


Sahpra lifts suspension on J&J vaccines with conditions
18 April 2021 - 10:07
The South African Health Products Regulatory Authority (Sahpra) has recommended that the temporary pause on the rollout of the Johnson & Johnson vaccine be lifted “provided that specific conditions are met”.
Image: Alon Skuy
The SA Health Products Regulatory Authority (Sahpra) has recommended that the temporary pause on the rollout of the Johnson & Johnson vaccine be lifted “provided that specific conditions are met”, the organisation said in a statement on Saturday evening.
“These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder. ....

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'No reason for widespread concern' over vaccines and rare clots, say MRC and Sisonke researchers


No reason for widespread concern over vaccines and rare clots, say MRC and Sisonke researchers
Risk of developing blood clots after a Covid-19 vaccination is much lower than the risk of clotting after being infected with Covid-19, a University of Oxford study found
16 April 2021 - 18:11
SA Medical Research president Glenda Gray, left, and UCT professor Linda-Gail Bekker, the two co-principal investigators of the Sisonke implementation study, carrying the first dose of vaccine through Khayelitsha Hospital.
Image: File photo
The risk of developing extremely rare blood clots after a Covid-19 vaccination whether the Johnson & Johnson, Oxford-AstraZeneca or the mRNA vaccines of Pfizer and Moderna is much lower than the risk of clotting after being infected with Covid-19, a new study by the University of Oxford has found. ....

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Johnson & Johnson to revise Covid-19 vaccine study, exclude pregnant health workers from trial


Johnson & Johnson to revise Covid-19 vaccine study, exclude pregnant health workers from trial
By Antony Sguazzin
(Bloomberg) – Johnson & Johnson will revise Covid-19 vaccine study protocols and exclude pregnant health workers from a trial in South Africa set to include 500,000 people after US regulators halted the rollout of the shot on concerns of rare and severe blood-clotting side effects.
While all studies are paused, plans to run trials on children and pregnant women in South Africa have been set aside for now, Glenda Gray, the co-lead of the South African studies, said in an interview on Wednesday.
The research team will meet with South African regulators later on Wednesday, she said. South Africa is relying on the vaccine for much of its planned rollout after it was found that AstraZeneca’s shot had reduced effectiveness against a variant first identified in South Africa. ....

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