- J&J Covid-19 vaccinations have been paused after extremely rare cases of blood clotting emerged in the US.
- US health agencies are conducting investigations to determine if there's a causal link between the clotting and vaccinations.
- Two local experts believe the Sisonke vaccine study will likely resume within the next few days.
The Johnson & Johnson Covid-19 vaccine rollout in South Africa was temporarily suspended on 13 April after reports emerged of six cases of severe blood clots among 6.8 million people who received the jab in the US.
"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," Health Minister Zweli Mkhize said in a briefing.
Healthcare workers are being vaccinated in the country as part of the Sisonke Covid-19 vaccine study.
As of 12 April, close to 290 000 healthcare workers received the jab.
On Wednesday morning, the SA Health Products Regulatory Authority (Sahpra) stated that it had reviewed the data from the Sisonke study and that no major safety concerns had been identified in the healthcare workers who took part in the study, Health24 reported.
"Sahpra has requested a pause in the implementation of the Sisonke study to enable it to review the relevant data and further updates will be communicated in due course. It is envisaged that this process will take a few days," it said.
In a statement on Saturday evening, the regulatory authority said that "based on a review of available data", it recommended the pause on the Sisonke study be lifted, "provided that specific conditions are met", News24 reported. These conditions include, among others, strengthening, screening, and monitoring recipients of the vaccine who are at high risk of a blood clotting disorder.
According to The Washington Post, the US Food and Drug Administration (FDA) and Centres for Disease Control and Prevention (CDC) are investigating this possible side-effect and a review is expected to conclude within days.
Study expected to resume
Professor Ian Sanne, an infectious diseases specialist, who is part of the Sisonke leadership team, told Health24 it is expected that the study will be taken off hold within a couple of days.
"The hold is just to update the regulatory information, the informed consent, and the protocol to be more specific on monitoring adverse events related to clotting," he said.
Sanne added that the call centre is available to anyone who received the jab and may be experiencing any adverse side-effects. Medical personnel will engage with and support these participants, he said.
J&J aware of events
J&J released an updated statement on Tuesday, noting that they are "aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our Covid-19 vaccine".
They, therefore, made the decision to delay the rollout of their vaccine in Europe and to pause vaccinations in all Janssen (the vaccine arm of J&J) Covid vaccine clinical trials, while they update guidance for investigators and participants.
Framing the 'pause' as positive
Professor Wolfgang Preiser, the head of the medical virology department of pathology at Stellenbosch University, said it was unfortunately "another one of those lose-lose situations" – that if inoculations were to continue, scientists and officials would be accused of risking people's lives, but that, on the other hand, a temporary suspension would end up delaying immunisation, which desperately needs to move ahead as quickly as possible.
However, the fact that these cases were found is comforting, although the challenge will be to frame this pause as something positive, said Preiser.
"I find it good that the systems seem to be working: the cases were found and the possible link is being investigated. This is as it should be and is very comforting.
"People will probably see it as something negative, especially if they are skeptical about the vaccine in any case. While I still hear the odd person claiming they do not know anyone who had Covid-19 badly or died from it, most people, like myself, have witnessed its potentially devastating effects first- or second-hand.
"Looking at colleagues, staff, neighbours and friends that succumbed, and their mourning relatives, I encourage all my friends to get vaccinated when they have a chance to – like I did," he advised.
Understanding the risk
As for whether we should be overly concerned about receiving the vaccine going forward, Preiser said: "It comes down to a small risk of serious illness due to the vaccine (yet to be confirmed) versus delaying the immunisation of susceptible people (which is risky for them and for their contacts).
"On balance, and based on what is known so far, I would argue for continuing the use of the J&J vaccine while informing recipients of the small risk, what they should look out for, and ensuring that any cases are recognised and treated promptly and well."
'One in a million complication'
Sanne weighed in, saying that if the news has fuelled vaccine hesitancy, he would remind everyone that in those people who do develop Covid, the disease caused by SARS-CoV-2, 16.5% develop coagulation abnormalities. And in those who die due to the disease, post-mortem results indicate that a certain number of cases have had clotting in the lungs.
"In my view, this is a rare, one in a million, complication in vaccines that are targeting severe disease. We need to be very careful with the vaccines, but I think that we don't have a choice but to move forward with the vaccination programme," he said.
Preiser echoed these thoughts, saying: "One has to keep in mind that the risk appears to be extremely small: one in a million or thereabout.
"It is absolutely expected that such small risks (assuming that there is a causal relationship with the vaccine, which has yet to be proven) are only found once a product (the same goes for drugs – side-effects kill tens of thousands every year, yet one does not usually hear about it) is used at large scale."
Fortunately, the few people who do end up developing the blood clots can be treated.
Professor Linda-Gail Bekker, co-lead investigator of South Africa's Sisonke Covid-19 vaccine trial, told Health24 that doctors are being cautioned against using heparin, a common blood thinner, but that there is an immune globulin treatment that can be used.
"We are trying to make sure that these protocols are widely known. This is available commercially and can be used to treat individuals with the problem," she said.
If you have received the vaccine and experience a severe headache, abdominal pain, leg pain or shortness of breath within three weeks after your vaccination, you should consult a doctor, Bekker advised.