J&J vaccine rollout suspended, final decision expected soon

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A nurse loads a syringe with a dose of Johnson & Johnson's Covid-19 vaccine.
A nurse loads a syringe with a dose of Johnson & Johnson's Covid-19 vaccine.
Stephen Zenner/SOPA Images/LightRocket via Getty
  • The health ministry has temporarily paused the rollout of the J&J vaccine.
  • The MAC will meet on Wednesday to discuss the way forward. 
  • A final decision is expected soon. 

South Africa's Covid-19 vaccination plans have hit a new snag.

The health ministry decided to halt the Johnson & Johnson (J&J) vaccine rollout after the US Food and Drug Administration (FDA) made a similar decision.

The FDA reported that six women developed blood clots after using the vaccine. Over six million US residents have been injected with the vaccine.

Locally, more than a million doses of the J&J vaccine are supposed to be delivered next week by the Aspen facility in the Eastern Cape. 

Mkhize, in his announcement on Tuesday evening, said after consulting with health experts: "We have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated."

This is the second time the country has paused the rollout of a Covid-19 vaccine.

The AstraZeneca vaccine was halted just a few days before it was rolled out after it was found to not be efficacious against the 501Y.V2 variant. At the time, the pause was supposed to be temporary, but a decision was made to sell the one million vaccines to the African Union. 

The government then decided to roll out the J&J vaccine to healthcare workers as part of the Sisonke implementation study. Now, the vaccine, which was seen as a saving grace after the AstraZeneca debacle, is also facing international scrutiny.

READ | US to call for pause on J&J's Covid-19 vaccine after 6 recipients develop 'rare side effect' - report

On Wednesday morning, the Ministerial Advisory Committee (MAC) on vaccines is expected to meet.

The South African Health Products Regulatory Authority (Sahpra) is also investigating the link between the blood clots and the vaccine.

A decision on whether to continue using the vaccine is expected to be made in the next few days, Mkhize said. 

Professor Glenda Gray, the co-principal investigator for the local J&J trial, said no blood clots had been reported in the nearly 290 000 healthcare workers who took part in the Sisonke trial. 

"It's important to note that we have seen these rare thromboembolic events in other vaccines - the Johnson & Johnson, Pfizer, Moderna and AstraZeneca. We are trying to establish whether the occurrences of this are the same or different in the various vaccines."

Sahpra chairperson Professor Helen Rees said the halting of the rollout was about being cautious. She said they were investigating the link between the vaccine and the blood clots.

"The other thing that we have to think about is what is the benefit of vaccines to individuals and to society versus the risk that is tiny. That is the conversation that we must have, and the regulator will be very honest with the public."

Professor Mosa Moshabela, the University of KwaZulu-Natal's acting deputy vice-chancellor of research and innovation, said local authorities should closely monitor the US findings. 

Moshabela said the health department should be transparent in whatever decision it makes regarding the J&J vaccine.

He added that it would have been wise to roll it out, as it is the only vaccine the country currently has, and the number of reported blood clots was low.

"The one in a million risk is very rare," Moshabela said.  

Vaccine timelines

Phase 2 of the vaccine rollout is expected to start in May, targeting vulnerable groups.

Mkhize said, despite the pause in the J&J rollout, the country would still reach its vaccination targets.

An additional 10 million doses of the Pfizer-BioNTech vaccine have been secured.

"We expect just under two million to be delivered in May." 

This, he said, meant the country had secured 30 million doses of the Pfizer vaccines.

"It shows that in the extremely unlikely event that the Johnson & Johnson is completely halted, we will not have any impediment to continuing with phase 2 of our rollout."

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