J&J Covid-19 vaccine study to resume on Wednesday

A research study in SA further evaluating Johnson & Johnson’s (J&J) Covid-19 vaccine in the field will resume on Wednesday, the health ministry said, after the study was paused over rare cases of blood clots in people who received the vaccine.

During the pause, it was established there is a one in a million chance of getting a clot after receiving the vaccine so regulators across the world have recommended the continued use of J&J’s shot, the ministry said.

The SA Health Products Regulatory Authority, SA Medical Research Council and health ministry have worked to ensure there is intensified pre-vaccination assessment and post-vaccination monitoring when the J&J study resumes, it said.

U.S. regulators recommended pausing the use of the single-shot earlier this month due to extremely rare cases of blood clots but on Friday said the United States could restart vaccinations. Europe's drug regulator has backed its overall benefits against any risk.

The Sisonke study is being carried out by the National Department of Health, SA Medical Research Council and Johnson & Johnson among others.

"It is much better to have the vaccine than to avoid taking it for fear of getting a blood clot," Health Minister Zweli Mkhize said in a statement released by the health ministry.

Some 290,000 healthcare workers have been given J&J's vaccine in the study so far out of a target of 500,000.

It comes as SA, the African country with the highest number of recorded coronavirus infections and Covid-19 deaths, is counting on J&J's vaccine to ramp up immunisations after a slow start.

The suspension of the J&J study was the latest setback for SA's immunisation efforts, after it ditched plans to kick-start vaccinations with AstraZeneca's shot in February. A trial showed the AstraZeneca vaccine had greatly reduced efficacy against the dominant local coronavirus variant, and the government has since sold its AstraZeneca shots to other African countries.

The country's health regulator approved Johnson & Johnson's Covid-19 vaccine in early April and the government has ordered 31 million doses, with the first commercial batch of 1.1 million doses due to be dispatched in the coming days.

SA has also secured 30 million doses of Pfizer's two-shot vaccine and expects the first 650,000 doses to arrive before the second phase of the country's vaccination programme, which starts on May 17 and targets the elderly and essential workers among others.

Reuters