J&J to Revise Trial Protocols, South African Study Lead Says
(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 U.S. 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 Plc’s shot had reduced effectiveness against a variant first identified in South Africa.
The study involving health workers known as Sisonke is expected to provide valuable date on safety because of its size. It will also shed light on the effect of the vaccine on HIV-positive people and the vaccine’s efficacy against the dominant variant in South Africa, Gray said.
Future participants will also be asked more detailed questions about previous bleeding disorders before being vaccinated, she said.
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