SA regulator says J&J shot can be given to pregnant women

South Africa’s drug regulator has said that Johnson & Johnson’s Covid-19 vaccine can be given to pregnant women with co-morbidities or at high risk of contracting the coronavirus.

The South African health ministry said SAHPRA had previously said pregnant and breast-feeding women should be excluded from a local research study evaluating the J&J vaccine’s efficacy.

INSIDERGOLD

Subscribe for full access to all our share and unit trust data tools, our award-winning articles, and support quality journalism in the process.

That research study, which aims to immunise 500 000 health workers, resumed on Wednesday after it was temporarily suspended over extremely rare cases of blood clots in people given J&J’s vaccine in the United States.

But in recommendations posted on its website on Thursday, the regulator said pregnant women who have co-morbidities or are at high risk of exposure to Covid-19 like health workers “may be vaccinated in consultation with their health care provider”.

“Women who are breastfeeding should be counselled on the absence of information in this regard and a benefit-risk assessment should be made by the enrolling clinician,” it said.

Further studies were planned in the coming months to assess the risks of being given the vaccine during pregnancy, it said.

The worst-hit country on the African continent in terms of reported coronavirus infections and deaths has so far vaccinated over 307 000 health workers with J&J’s shot while it waits for its first batch of commercial doses to become available.

It has ordered 31 million doses of J&J’s one-shot vaccine and 30 million doses of Pfizer’s two-shot vaccine – enough for a combined 46 million of its 60 million people – and is counting on them to ramp up immunisations after a slow start.