Thursday, 28 March, 2024
HomeSouth AfricaJ&J roll-out falters again despite SAHPRA clearing jab for pregnant women

J&J roll-out falters again despite SAHPRA clearing jab for pregnant women

While health regulator SAHPRA has given pregnant and breastfeeding women the green light to receive the Johnson & Johnson jab, the vaccine's rollout has been further delayed as a “precautionary” safety measure after problems at a US company contracted by J&J to make a key vaccine ingredient.

“Pregnant women are at higher risk of severe COVID-19 compared with women of childbearing age who are not pregnant, and Covid-19 has been associated with an increased risk of preterm birth,” the SA Health Products Regulatory Authority (SAHPRA) is quoted in TimesLIVE as saying.

The regulator announced that pregnant and breastfeeding women in South Africa “may be vaccinated” with the J&J jab “in consultation with their healthcare 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.”

TimesLIVE reported earlier that the vaccination of pregnant and breastfeeding mothers with the jab had been temporarily halted pending investigations into potential side-effects. Health minister Zweli Mkhize confirmed this while briefing parliament’s portfolio on health on developments regarding the J&J clinical trials and vaccine procurement for the country.

The Sisonke COVID-19 vaccine study, under which health workers in South Africa are being given the vaccine, resumed this week after being briefly halted in response to reports of recipients developing rare blood clots abroad.

However, the release of South Africa’s first commercial shipment of the Johnson & Johnson (J&J) COVID-19 vaccine from Aspen Pharmacare’s Gqeberha facility is being delayed as a “precautionary” safety measure after problems at a US company contracted by J&J to make a key vaccine ingredient.

 

BusinessLIVE reports that Health Minister Zweli Mkhize announced on Sunday (2 May) that while Pfizer’s planned deliveries are still on track, the delay in the J&J shots could slow the start of the vaccine rollout, which begins on 17 May. Mkhize said international regulatory agencies, including the US Food & Drug Administration (FDA) and the European Medicines Authority, are assessing J&J stock worldwide, and that these assessments are still under way.

The government has ordered 31m doses of J&J’s single-shot vaccine, which it is banking on to be the workhorse of its national inoculation drive since it is easier to administer and handle than Pfizer’s double-dose vaccine, which requires ultracold storage.

Aspen has 1.1m doses of J&J’s COVID-19 vaccine ready for dispatch, but cannot release the stock until medicine regulators in the US and Europe give the nod to J&J stock worldwide after mistakes by its US contract manufacturer, Emergent BioSolutions, Mkhize said. The government expects Aspen’s stock will be released by mid-May, he said.

It’s likely to take several days for the vaccines to make their way to inoculation sites once they are dispatched, meaning the 17 May target date for their roll-out may be missed. That’s a scenario the government will want to avoid, given it’s contending with Africa’s worst coronavirus outbreak and facing criticism that it has not been proactive enough in securing vaccines.

 

With the use of the J&J vaccine unpaused, SA on Thursday of last week hit a total of more than 300,000 doses of COVID-19 vaccines administered. Business Insider reports that in a per-population measure widely used to compare the rate of vaccination between countries, that equates to 0.5 doses per 100 residents – a rate slower than all its neighbours and chosen peers.

South Africa lags far, far behind the rest of the BRICS countries with which it considers itself aligned. In Brazil, total doses administered come to more than 19 per 100 people, for Russia that number is above 13, and India is approaching 11 doses per 100 people.

Business Insider reports that South Africa also ranks very low in regional and continental terms. Every neighbouring country has administered more doses per person than South Africa, with Zimbabwe above 3 doses per 100 people, and Namibia just barely above South Africa's level of vaccination.

Other countries on the continent significantly further down the line with vaccinations include Angola, Djibouti, Ghana, and Senegal.

 

Full TimesLIVE report (Open access)

SAHPRA statement

Full BusinessLIVE report (Restricted access)

Full Business Insider report (Open access)

 

See also MedicalBrief archives:

Mortality 20x higher in pregnant women with COVID but SAHPRA says no to vaccination

COVID may increase blood clot risk in women who are pregnant or taking oestrogen

CDC outlines who should — and shouldn’t — take J&J’s vaccine

SA awards first vaccine import and distribution contracts and makes up with J&J

EU medicines regulator clears J&J vaccine for continued use

J&J vaccine paused over rare blood-clots in US, Europe and SA

MedicalBrief — our free weekly e-newsletter

We'd appreciate as much information as possible, however only an email address is required.