Covid-19: Sahpra approves vaccine use for high-risk pregnant women

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  • The SA Health Products Authority Regulator says the Covid-19 jab can be administered to pregnant women who have a high risk of contracting the disease.
  • Similarly, breastfeeding women can also receive the vaccine, although the effects of it are unclear.
  • South Africa's vaccination rollout resumed this week.

Pregnant women who have comorbidities or are at high risk of Covid-19 infection will be able to receive Covid-19 vaccinations, according to the South African Health Products Regulatory Authority (Sahpra).

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In a statement on Thursday, the regulatory body said pregnant women may receive the Johnson & Johnson vaccine, in consultation with their healthcare providers, as part of the Sisonke programme and national vaccine rollout drive.

The country's vaccination programme resumed on Wednesday, after the Johnson & Johnson vaccine rollout was halted. It was paused after it emerged that there were six cases of vaccine-induced thrombotic thrombocytopenia in America.

"It has since been established there is a one in a million chance of getting the clot after the vaccine and that it appears that women between the ages of 18 and 48 years...are particularly at risk. With such a low probability of developing a clot, all the regulators across the world have recommended the continued use of [the] Johnson & Johnson [vaccine]," Mkhize previously told News24.

Sahpra added that pregnant women had a higher risk of severe Covid-19 and that the disease was associated with an increased risk of pre-term birth.

"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," the organisation said in a statement.

"Pregnant women at high risk of exposure to SARS-CoV-2 (e.g., health workers) or who have comorbidities which add to their risk of severe Covid-19 disease, may be vaccinated in consultation with their healthcare provider[s]."

Similarly, women who are breastfeeding are also eligible for the vaccine, but uncertainty around the effects remains, according to the regulator.

"It is not yet clear whether the Janssen (Johnson & Johnson) 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for immunisation against Covid-19. It must be noted that the WHO (World Health Organisation) does not recommend discontinuing breastfeeding after vaccination."

BusinessLIVE reported that pregnant women had previously been excluded from the Sisonke vaccine study.

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