- There has been a delay in the deployment of the J&J vaccine due to a lack of adherence to proper standards at a US manufacturing plant.
- The Director General of Health, Dra. Sandile Buthelezi said the U.S. Food and Drug Administration was expected to make an announcement Friday.
- This has delayed the launch of vaccines at the Aspen facility in Gqeberha.
Health Director General Dr. Sandile Buthelezi says the department expects the Food and Drug Administration (FDA) to make an announcement about the Johnson & Johnson (J&J) vaccine on Friday.
This is due to a delay in the delivery of vaccines to South Africa, which was caused by non-compliance with proper standards at a US manufacturing plant.
“We hope the FDA makes an announcement this Friday and we can get our J&J [vaccine] very soon, ”Buthelezi said.
On Wednesday he was practically speaking at a Black Business Council summit in Johannesburg.
The country has commissioned just over 30 million vaccines from J&J.
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In a statement in late March, J&J said its quality control process had identified a batch of pharmacological substance in Emergents Biosolutions that did not meet its quality standards.
“This batch was never advanced to the filling and finishing phases of our manufacturing process,” the company added.
The New York Times later reported that the FDA had not eliminated doses of Covid-19 at the plant.
According to reports, Emergency BioSolutions workers accidentally contaminated a batch of J&J vaccines with a harmless virus used to make the AstraZeneca vaccine.
This has led to a delay in the deployment of vaccines at the Aspen facility in Gqeberha. Aspen has a contract to fill and package the J&J vaccine at a local plant.
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Deputy Health Minister Joe Phaahla, who was also at the summit, said the department remained optimistic that the issue would be resolved sooner rather than later.
“Johnson & Johnson has suffered setbacks in the US, which unfortunately have also had a big effect on us, so we are still waiting for the results from the international regulatory authorities. Mainly in the US, where there were some challenges in terms of considers good manufacturing practices to be unfulfilled. “
Phaahla added that about two million vaccines were ready to be sent to Gqeberha’s facilities.
Launch of vaccines
Buthelezi said more than three million people have registered with the Electronic Vaccination Data System (EVDS), and that the country had 444 active vaccination sites.
With the opening of more non-governmental vaccination sites, he added that the country would be able to reach 150,000 vaccines daily.
Last Monday, the first vaccination site in the workplace began at Implats, a mining group, in Rustenburg.
Buthelezi said just under 600 people have been vaccinated so far.
“We have agreed to pilot the module to see how it works. We have chosen for now a place in the mining sector, which is Implats in Rustenburg, which has already started.
“Next week we will start a manufacturing site, we will also start a site in a state-owned company and an informal sector site. We will use the taxi sector here. We have been working very well with Midrand taxi drivers associations and we will establish a site there.” , added.
A public sector and local government site will also be created.