Government expecting an announcement from US FDA on J&J vaccine delay

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A Johnson & Johnson logo is seen in front of a medical syringe and a vial with coronavirus vaccine.
A Johnson & Johnson logo is seen in front of a medical syringe and a vial with coronavirus vaccine.
SOPA Images/Getty
  • There has been a delay in the rollout of the J&J vaccine due to a lack of adherence to proper standards at a manufacturing plant in the US. 
  • Health director-general Dr Sandile Buthelezi said the US' Food and Drug Administration was expected to make an announcement on Friday.
  • This has caused a delay in the rollout of vaccines that are at Aspen's Gqeberha facility. 

Health director-general Dr Sandile Buthelezi says the department expects the Food and Drug Administration (FDA) to make an announcement on the Johnson & Johnson (J&J) vaccine on Friday.

This follows a delay in the delivery of vaccines to South Africa, which was caused by a lack of adherence to proper standards at a manufacturing plant in the US. 

"We expect that this Friday, the FDA will make an announcement, and we might be able to get our J&J [vaccine] very soon," said Buthelezi. 

He was speaking virtually at a Black Business Council summit in Johannesburg on Wednesday.

The country has ordered just more than 30 million vaccines from J&J.

READ | SA’s last thousand doses of J&J Sisonke vaccine will go to rugby and Olympic stars this week

In a statement at the end of March, J&J said its quality control process had identified one batch of drug substance at Emergent Biosolutions that did not meet its quality standards.

"This batch was never advanced to the filling and finishing stages of our manufacturing process," the company added. 

Thereafter, The New York Times reported the FDA had not cleared Covid-19 dosages at the plant. 

Workers at Emergent BioSolutions reportedly accidentally contaminated a batch of J&J's vaccine with a harmless virus used to manufacture AstraZeneca's vaccine. 

This has caused in delay in the rollout of vaccines that are at Aspen's Gqeberha facility. Aspen has a contract to fill and package the J&J vaccine at a local plant.

READ | How much protection you get from one shot of Pfizer, J&J, and others, according to the best available data

Deputy Health Minister Joe Phaahla - who was also at the summit - said the department remained optimistic the issue would be sorted out sooner rather than later. 

"Johnson & Johnson has suffered setbacks in the USA, which unfortunately has had a ripple effect also on us, so we are still waiting for the outcomes from the international regulatory authorities. Mainly in the US, where there were some challenges in terms of what is regarded as good manufacturing practices which were not adhered to."

Phaahla added around two million vaccines were ready to be dispatched at the Gqeberha facility. 

Vaccine rollout 

Buthelezi said more than three million people have registered on the Electronic Vaccination Data System (EVDS), and the country had 444 active vaccination sites.

With the opening of more non-government vaccination sites, he added the country would be able to reach 150 000 vaccinations per day. 

Last Monday, the first workplace vaccination site went live in Implats, a mining group, in Rustenburg.

Buthelezi said they have been able to vaccinate just under 600 people so far. 

"We have agreed to pilot the module to see how it's working. We have chosen for now, one site in the mining sector, which is the Implats in Rustenburg, which has already started.

"Next week, we will be starting one site in manufacturing, we will also be starting a site at a state-owned enterprise, and one site in the informal sector. We will be using the taxi sector here. We have been working very well with taxi associations in Midrand, and we will be setting up a site there," he added. 

A site in the public sector and local government will also be set up. 

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