HEALTH-E NEWS

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

By Amy Green for Health-e news 18 April 2021

(Photo: Gallo Images / Sharon Seretlo)

Healthcare workers and experts speak about their reactions to the suspension of the Covid-19 Johnson & Johnson (J&J) vaccine due to safety fears.

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”.

Professor Francois Venter, former senior member of the Covid-19 Ministerial Advisory Committee and head of the Ezintsha health unit at the University of the Witwatersrand, said suspending the vaccine roll-out, even for a few days, was a “terrible decision”. 

Venter, who has also received the J&J jab, said “the South African vaccine programme is in a very poor state”. “We’ve vaccinated 300,000 highly motivated health workers in eight weeks. But to hit government targets, we need to be achieving those numbers every day. And that’s if vaccines are delivered in time. It’s a crisis,” he told Health-e News

Lebohang Mokoena, an occupational health nurse from Johannesburg, agreed with Venter that the suspension was a bad idea.“I think the suspension of the vaccine has caused more confusion, fear and lack of trust in our health system.” Mokoena was vaccinated with the J&J jab in late March. “I think they should have continued with the roll-out of the vaccine as we don’t have blood clot cases here in South Africa. From my point of view, even if there was proof of a connection, it’s only six women out of seven million people, which is not such a big deal if you consider how extremely rare that is,” he said.

Tlhompo Magabe, a nurse from the Mahikeng Provincial Hospital in the North West was vaccinated with the J&J vaccine earlier in April and said that she would have liked to see the vaccine roll-out continuing because health workers are exposed to the virus every day. 

“I am a bit disappointed that the vaccine rollout has been paused due to fears of blood clotting. This vaccine has put our fears to rest because as frontline workers we are exposed to the virus every time we report for duty,” she said. 

Dean of Medicine at Wits University Professor Shabir Madhi said the pause is only appropriate in a clinical trial setting, but suggested South Africa shouldn’t react so quickly and without question to the decisions made by regulatory bodies of developed countries. 

“The pause of the J&J vaccine in SA [where it is being used as part of a clinical trial] is justified in that investigators need to update the consent form to alert the volunteers of this newly identified potential safety concern. However, the same does not hold true when used as part of a roll-out programme, where such risk can be communicated differently and the decision on the use of the vaccine needs to also consider the risk-benefit potential at an individual and societal level. The risk of the identified side effect is just under one in a million for the J&J vaccine. In contrast, the risk of developing the same condition in people with Covid-19 is 14-66 fold higher,” he said.

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”.

“Also, while it might be an option to pause vaccination with a particular vaccine if spoilt for choice with the number of vaccines that are available, this is unfortunately not the case for countries which have limited options of the number of Covid vaccines that are available. Hence, the decision-making should also be guided by the local context. We need to guard against knee-jerk reactions to decisions made by other regulatory authorities, which might be applicable to their setting, but not necessarily generalisable to our setting,” said the former head of the National Institute of Infectious Diseases. 

Dr Sandile Kubheka, internal medicine registrar at Inkosi Albert Luthuli Central Hospital in KwaZulu-Natal (who was vaccinated in March), agreed with Madhi. “My view is the decision might have been premature. The risk [small, if any] far outweighs the catastrophic effect of Covid-19. The roll-out should have continued,” he said.

Kubheka, who made news in 2018 when he graduated as a doctor at the age of only 20, said that “we’re doing so badly in terms of the numbers vaccinated and are lagging behind a lot of countries at this stage”. 

“We haven’t reached the third wave yet. Before it comes we need to have vaccinated enough people. This decision was made based on an international body and my view is that it is not the correct decision for our own context,” he said. 

For Madhi, Covid-19 is a far bigger concern. “The risk of dying from Covid-19 in SA right now is excessively higher than developing the type of side effect that is being investigated.” DM

Additional reporting by Ndivhuwo Mukwhevo, Marcia Zali, Bontle Motsoeneng, Max Matavire, Nthusang Lefafa, Lilita Gcwabe and Sandile Mbili.

Gallery

"Information pertaining to Covid-19, vaccines, how to control the spread of the virus and potential treatments is ever-changing. Under the South African Disaster Management Act Regulation 11(5)(c) it is prohibited to publish information through any medium with the intention to deceive people on government measures to address COVID-19. We are therefore disabling the comment section on this article in order to protect both the commenting member and ourselves from potential liability. Should you have additional information that you think we should know, please email [email protected]"

SPOTLIGHT

‘Lies and cover-ups’: What the Charlotte Maxeke fire tells us about health and safety at Gauteng hospitals

By Ufrieda Ho for Spotlight