J&J vaccine suspension: Mixed reaction from South African health professionals

The J&J vaccine has come under fire recently since six women in the United States (US) experienced blood clots after receiving the vaccine. There is yet to be any evidence made public if the blood clots were connected to the J&J vaccine or to other issues. As a precaution, the US’s Federal Drug Authority (FDA) has temporarily suspended use of the J&J vaccine to review the evidence of the situation. 

On Wednesday 14 April the South African Health Products Regulatory Authority (SAHPRA) issued a statement announcing that the use of the J&J vaccine in South Africa would also be temporarily halted while scientific reviews were conducted.

But not everybody is in favour of the suspension. 

Tebello Olga Sithole, a nurse who works at a pharmacy in Sasolburg in the Free State and who received the J&J vaccine in March, said the suspension was “unfortunate”. 

“My view is that all vaccines or medications have their adverse effects and looking at the large number of people who have been vaccinated, it’s only a handful who presented with this problem. I went to get vaccinated knowing the slight risks involved,” she said. 

In a statement, Sahpra noted that after the decision in the US by the Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) to pause the use of the J&J vaccine in that country, it met with the Sisonke study team and the manufacturer, Janssen Pharmaceutical, in South Africa on 13 April 2021. Sahpra said it was given updated data on the Sisonke study and awaiting further data from the manufacturer and the FDA. 

Sahpra chairperson Professor Helen Rees told Sahpra that the clotting risk was extremely rare. “There is no need to panic,” Rees said. “Over 290,000 healthcare workers have already received the J&J vaccine in South Africa and nearly seven million have received it in the US.”

Nonceba Mofu, a nurse at Livingstone Hospital in Gqeberha in the Eastern Cape who received the J&J jab, said that the news of the temporary suspension has left her feeling confused. Another Gqeberha nurse, Mbulelo Schultz is “not worried at all”, about the suspension or the safety concerns.  

But Rees said the data collected and analysed so far as part of the phase three Sisonke study, through which the J&J vaccine is being rolled out, has not shown any cases of clotting in those vaccinated in SA. 

“Firstly, we don’t know if there is any association [with the blood clots] and the vaccine, and secondly, if there was a link made, it equates to less than one case per million people which makes it extremely rare,” she said. 

She explained that because the J&J vaccine is being rolled out as part of a clinical trial, the trial’s ethics committee and Sahpra agreed to temporarily suspend use of the vaccine to “really just be cautious”. 

“We’re talking to the FDA [and] the World Health Organisation … to get a better sense of this information. We’re hoping for this to happen in a matter of a few days because we don’t want this to delay the roll-out,” she said.  

Dr Strike Stevens Mabasa, a general practitioner working in Bethlehem in the Free State, said he believed the vaccine’s suspension was the correct move. “I, for one, believe that it’s a good move by [SAHPRA] to temporarily suspend the vaccination pending new information that will come to light,” he said. 

Mabasa, who was vaccinated with the J&J vaccine in February, agreed with Rees that the relative risk of this yet-unproven side-effect is small. 

“Most people might regard six people out of seven million people vaccinated presenting with clots as insignificant, but a precautionary approach is prudent,” he said. 

Emilia Moloi, a nurse at the Tygerberg Hospital in Cape Town who has received the J&J jab, said she was “disappointed” that the vaccine roll-out was paused but agreed with the decision. 

“I believe that it was necessary for the government to pause the roll-out of the J&J vaccine temporarily, but I am concerned about the many workers who still need to get vaccinated,” she said. 

Tahulela Patience Lehaha, an oncology nurse at Polokwane Provincial Hospital in Limpopo, said she is not worried. “I received my jab a few weeks ago and I never experienced any side-effects. So far, I have never heard of anyone in South Africa who became sick or developed any condition after receiving the jab. My only worry now is that this will only delay people from getting their Covid-19 jabs. And the jab is the only way one can be sure that he or she has a better chance of not getting infected with this virus which has already claimed the lives of so many since the start of the pandemic,” she said.

Kgabo Mashala, a nurse at Tembisa Hospital in Ekurhuleni who has administered Covid-19 vaccines, said the suspension was “necessary”, but that there were risks associated with delaying the roll-out of the vaccine programme. “I think that the suspension is good because we need to follow precautions but I am concerned that it will further delay the roll-out and there are high-risk people who need the vaccine [such as] the elderly, those with comorbidities and those with compromised immune systems,” said Mashala.

She pointed out that since “we don’t yet have evidence that the vaccine is responsible for the clots, we should wait for the report confirming the cause. Plus, we also don’t know their medical history or what type of medication they might have been taking”.

Ntombifuthi Nhlapo, a lay counsellor in Mpumalanga who received the J&J jab last week, said the suspension was a “good thing”.

Cebile Madonsela, a clinical associate also from Mpumalanga, received the J&J vaccine earlier this month and is less sure than Nhlapo. “I think they did well with suspending the vaccine for now but I worry it will cause fear amongst the public and health workers,” she said. 

But there are those who are vehemently opposed to Sahpra’s decision.

Thabani Nqadu, who works at the Far East Rand Hospital in Gauteng and who has been vaccinated, said that “the suspension will negatively affect the vaccine rollout” and will create doubt about the safety and efficacy of the vaccine even among health workers. 

Madhi said although it’s important to be vigilant in identifying rare side effects, “acting on such information needs to be weighed in relation to risk and benefit profiling at an individual and societal level”.