Cape Town – Pregnant and breastfeeding women who have co-morbidities may now receive the Johnson & Johnson (J&J) jab under the Sisonke vaccination programme.
The South African Health Products Regulatory Authority (Sahpra) announced on Thursday, that pregnant women who are at high risk of exposure to Covid-19 may be vaccinated in consultation with their health-care provider.
“It is not yet clear whether the J&J 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.”
“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,” read the statement from Sahpra.
The regulatory body also mentioned that vaccines that use the same viral vector as the J&J vaccine have been given to pregnant people in all trimesters of pregnancy, including in a large-scale Ebola vaccination trial and that no adverse pregnancy-related outcomes, including adverse outcomes that affected the infant, were associated with vaccination in these trials.
The initial clinical trials of Covid-19 vaccines excluded women who are pregnant, and most studies excluded women who were lactating.
Two recent commentaries published in the SA Medical Journal, called for a more enabling, individualised and patient-centred approach to the question.
“While the theoretical benefit of maternal vaccination may outweigh the known risks associated with Covid-19 in pregnancy, pregnant and breastfeeding women have the right to autonomy and should be given the choice to vaccinate by making an informed decision in consultation with their health-care provider, using the data available,” said co-author of the report, Jarrod Zamparini.
The World Health Organisation (WHO) also does not recommend discontinuing breastfeeding after vaccination.