Sahpra approves use of Covid-19 vaccine on high-risk pregnant women

The administration of the vaccination will be monitored under the Sisonke vaccination programme in consultation with health practitioners.

The country resumed the use of the Johnson & Johnson vaccine on Wednesday.

The initial clinical trials of Covid-19 vaccines excluded women who are pregnant, while most studies excluded women who were lactating.

The health regulatory body says the inclusion of pregnant women in trials is necessary to determine the risks.

“While caution about the inclusion of pregnant and lactating women in early clinical trials, evaluating new vaccines is common, there is a growing global realisation that pregnant and lactating women should be included in clinical trials at an early and safe point in product development so that they are not excluded from the subsequent use of the product,” it said in a statement.

“In addition, other vaccines are specifically recommended during pregnancy because of the heightened risk of harm to mother and /or her infant.”

Breastfeeding women who receive the vaccine will also be provided with counselling.

“It is not yet clear whether the Janssen COVID-19 vaccine is excreted in breast milk. 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.

"Pregnant women at high risk of exposure to SARS-CoV-2  or who have comorbidities which add to their risk of severe COVID-19 disease may be vaccinated in consultation with their health care provider.

“Vaccination data should be collected as part of the ongoing Sisonke Study and by national pregnancy exposure registries once the vaccine is being rolled out.”

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