The medicines regulator has reversed its decision to exclude pregnant and breastfeeding women from the Sisonke Covid-19 vaccine study, clearing the way for them to be included when the national inoculation drive starts in May.
The Sisonke study aims to vaccinate 500,000 healthcare workers with Johnson & Johnson’s (J&J) vaccine. It resumed on Wednesday two weeks after it was ordered by the SA Health Products Regulatory Authority (Sahpra) that it be put on hold pending a probe into reports of rare blood clots among vaccine recipients in the US.
The resumption had been widely anticipated, but researchers and clinicians were shocked by Sahpra’s exclusion of pregnant and breastfeeding women, among the most at-risk groups, as it went against scientific advice previously given to health minister Zweli Mkhize.
Sahpra CEO Boitumelo Semete-Makokotlela then threw a curve ball on Tuesday night, saying the regulator was reviewing “all the available data” on not only the J&J shot but also the Pfizer-BioNTech one, raising the spectre that pregnant and breastfeeding women might be excluded from the mass vaccination drive. These are the two vaccines the government has ordered for SA.
Semete-Makokotlela told Business Day on Thursday that Sahpra had reviewed the available data and reversed its decision on pregnant and breastfeeding women, who can now receive Covid-19 vaccinations in the Sisonke study as well as in the national rollout.
“The exclusion was to allow us time as the regulator to look at all the data.
“That is the exercise we have done. Based on that detailed review, we are able to say they can be included,” she said.
Sahpra would require data on vaccinated pregnant and breastfeeding women to be collected by the Sisonke study and by the national pregnancy registry once the rollout begins.
Pregnant women are particularly vulnerable to Covid-19 as they are at increased risk of severe illness and death, and the disease makes them more likely to deliver their babies early.
Those who are healthcare workers are at heightened risk of exposure to the disease and urgently need the protection offered by vaccines, said Medical Research Council president Glenda Gray, one of the co-principal investigators on the Sisonke study.
“The exclusion caused a lot of heartache. Healthcare workers are four to seven times more likely to get Covid-19 than the general population,” she said.
She said Sahpra informed the Sisonke study researchers on Wednesday night that it had reversed its decision, and pregnant and breastfeeding women could receive the jabs, pending approval of an amended study protocol.
Gray said it would take several days to get all the paperwork in place as an amended protocol would need to be approved by the research ethics committees overseeing study sites as well as Sahpra, and changes would need to be made to the electronic vaccine registration system to reflect the inclusion of pregnant and breastfeeding women.
“We welcome the change because we do not think the first decision was well thought out.
“But given the processes we have to implement to realise this protocol amendment, we are worried that by the time all the approvals are in place, we will only have a week left to enrol people,” said Gray, referring to the Sisonke study coming to an end in mid-May.
The national vaccination campaign, which aims to inoculate more than 46-million people by March 2022, begins on May 17.
Sisonke study co-principal investigator Ameena Goga previously told Business Day that Sahpra had told researchers there was insufficient data to justify the inclusion of pregnant and breastfeeding women, but Goga said that in her view all the available data indicated the vaccine is safe. No other country has excluded pregnant and breastfeeding women, she said.
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