- SA will continue with its Covid vaccination programme
- The roll-out was temporarily suspended last week after rare cases of blood clots were reported in the US
- People who receive the vaccine in SA will be monitored by medical professionals, and side effects can be reported on an app
South Africa's Johnson & Johnson Covid vaccine roll-out will resume after Cabinet agreed to lift the temporary suspension based on a data review, News24 reported.
The programme was halted after reports emerged of six cases of blood clots among 6.8 million people who received the single-dose jab in the US.
But European health authorities investigated the cases, and on Tuesday, a statement by J&J noted that the European Union drug regulator said a warning should be added to the jabs, indicating a possible link to rare blood clots, but that the product’s benefits far outweigh the risks.
According to the South African Health Products Regulatory Authority (Sahpra), no major safety concerns had been identified in the healthcare workers who took part in the study.
What will happen now?
More than 280 000 healthcare workers have already been vaccinated in SA as part of the Sisonke Covid-19 vaccine trial.
After the programme was put on hold in SA, Sahpra released a statement on 17 April recommending that, "based on a review of available data", the pause on the study be lifted, "provided that specific conditions are met". These conditions included strengthening, screening, and monitoring recipients of the vaccine who are at high risk of blood clotting.
In the announcement of the resumption of the study, Acting Minister in the Presidency, Khumbudzo Ntshavheni, reassured that scientists will continue to monitor those who receive the jab.
Health Minister, Zweli Mkhize, is expected to announce the exact date the roll-out will recommence.
The country has ordered 31 million J&J vaccine doses. Delivery of the first one million jabs is expected by Monday.
The registration portal is now open to people 60 years and older as part of the preparation for phase two of the roll-out which will begin on 17 May 2021.
Reporting adverse effects: new app
Sahpra also recently launched a free mobile-based application that allows individuals to report any adverse side effects to several medicines and therapies, including the Covid-19 vaccines, Health24 reported.
Named the Med Safety App, it offers users, among other features, a way to report adverse drug reactions (ADRs); report adverse events following Covid immunisation (AEFIs); and receive news about medicine safety from Sahpra.
The Med Safety App is compatible with the latest iOS (minimum version 8) and Android operating systems (minimum version 3.0).
What experts said
Professor Linda-Gail Bekker, co-lead investigator of South Africa's Sisonke study, previously told Health24 that it’s important to remind ourselves that Covid infection itself can cause blood clotting problems. The pause in the roll-out, she said, was “really just time for regulators and ethics committees to review the data”, and ensure the public is informed about any important information regarding the blood clotting occurrences.
Professor Ian Sanne, an infectious diseases specialist, who is part of the Sisonke leadership team, also told Health24 last week that the study would likely not be on hold for a very long time.
"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, and gave reassurance 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 explained.
He pointed out that while the news might have fuelled vaccine hesitancy, there is data to show that in those people who do develop Covid disease, 16.5% develop coagulation abnormalities. And in those who die due to the disease, post-mortem results indicate that a certain number of cases 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.
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