Publications
- The decision to pause the Johnson & Johnson Covid-19 vaccination trial was the right thing to do, according to the Western Cape's head of health.
- Dr Keith Cloete explained that because the vaccine was still under trial, ethicists and scientific institutions were bound to pause it for the sake of caution while it investigates the six cases of clotting out of 6.6m people vaccinated in the US.
- No clotting cases were reported in South Africa, and health authorities are optimistic that the programme will resume.
The decision to pause the Johnson & Johnson Covid-19 vaccine trial was the right thing to do, the Western Cape's head of health believes.
Dr Keith Cloete explained that because the vaccine was still under trial, ethicists were bound to ask that the trial be paused to establish whether there was a causal link between the vaccine and the six cases of blood clotting reported out of 6.6 million vaccinations in the US.
"The big issue is just to explain the context," said Cloete during the province's weekly digicon on the management of the Covid-19 pandemic and the vaccination programme.
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"[The] J&J vaccine in this country has been made available via [the SA Health Products Regulatory Authority] for trial conditions," he explained.
"So we must remember that the Sisonke trial is still under trial conditions.
"So, what we are guided by, in terms of trials, is that you have ethics committees at various universities or research institutions."
Cloete said when the US Food and Drug Administration reported an "event" where six blood clots were reported out of the 6.6 million people vaccinated in the US, local scientific institutions and ethics committees were bound by trial ethics to stop the vaccinations in South Africa too.
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"So in a sense you would know from this that the research ethics committees contacted us and told us, guys as research ethics committees we are bound by the ethics. We know it's very, very cautious, we know it's probably a pause just to look at all the data, and in all likelihood, we will recommence again, but from an ethics perspective, it's the right thing to do."
Cloete said although the decision had implications in terms of trust in the vaccine and the vaccination programme, the decision to pause the trial was understandable.
Cloete said not a single clotting episode had been associated with vaccinations done in South Africa and local health authorities are optimistic the trial would resume soon.
Since launch of Sisonke J&J programme on 17 February, the Western Cape received 54 068 doses of the J&J vaccine. The Western Cape allocation of the final tranche of 200 000 is 36 240 doses received for the Sisonke J&J trial.
They will be split in two deliveries arriving 13 and 17 April respectively, but will only be used if the vaccine gets the go ahead again. As at 13 April, 53 507 healthcare workers in the province received the vaccine.
Vaccines
In the meantime, the Western Cape is proceeding with its planning for its part in the mass delivery of Pfizer and J&J vaccines for the next phase of the vaccination programme. It is also considering 30 unsolicited bids to provide vaccines.
This, while it has 736 patients with Covid-19 in hospital - 429 in public hospitals and 307 in private hospitals - 5% of the total of acute hospital admissions.
Cloete said the trial has been valuable not just in terms of providing protection to healthcare workers, but also helped fine tune planning for mass vaccinations.
If the pause on the J&J trial is lifted within the next few days, the remainder of the healthcare workers will be vaccinated, and from 16 or 17 May, the programme will shift to people who are 60 and older. From there it will progress to lower age groups.
Cloete said the people studying the trial logistics have picked up an element of "vaccine envy" among people, which makes it important to make sure that the registration systems are accurate and abided by.
The Western Cape's surveillance systems indicate that the province still has a relatively low number of cases of Covid-19, and it has been scouring for Easter holiday "clusters".
"As yet we have not picked up a big escalation of cases linked to Easter weekend activities," he said as he presented surveillance data.
Many of the newer cases coming from the Tygerberg north region are emanating from private sector testing before operations, and for travel purposes.
Cloete said there have been some outbreaks which have been contained, but poor compliance with non-medical interventions in Stellenbosch were still worrying.
Non-medical interventions include social distancing, mask wearing and limiting gatherings.
Good news for the department was that only 12 confirmed cases of Covid-19 were reported among healthcare workers in the Western Cape, compared with a horrific December period.
