The government aims to scrap the controversial compensation scheme it was obliged to establish by Covid-19 vaccine manufacturers when it enters into new supply contracts, a top health department official said on Monday.
Pharmaceutical companies Pfizer and Johnson & Johnson (J&J) agreed last year to supply SA with desperately needed shots on condition the government establish a Covid-19 vaccine injury no-fault compensation scheme. The scheme was established in terms of regulations to section 27(2) of the Disaster Management Act, and indemnifies vaccine manufacturers and the government from claims.
“This scheme is solely for the commitments made in the two contracts (with Pfizer and J&J). If we buy more vaccine in future we will do it as a procurement without this condition,” said the health department’s deputy director-general for National Health Insurance Nicholas Crisp.
The government anticipates the scheme will come to an end once SA has used up the 24-million vaccine doses it has on hand, he said. About 11.5-million of the shots are from Pfizer, and the balance from J&J. Given SA’s sluggish vaccination rate, this is likely to take more than a year.
Crisp’s comments come as the government faces mounting legal and political pressure to end the national state of disaster, and use alternative means to manage the coronavirus pandemic. One of the sticking points has been how to manage the compensation scheme for vaccine injuries once the state of disaster is lifted.
The government has decided to maintain it as a stand-alone entity, using amended regulations to the act, as there are no suitable provisions in the National Health Act, said Crisp.
Proposed amendments to regulations issued in terms of section 27(2) of the Disaster Management Act, which breathed life into the scheme last year, were released for public comment on Thursday, with the public given until 5pm on Saturday to comment. The draft regulations were accompanied by directions that detail which vaccines are covered by the scheme, which include not only the vaccines purchased directly from Pfizer and J&J, but also donated supplies and stocks obtained via the international vaccine financing initiative Covax.
The scheme is funded by the government, without any contributions from vaccine manufacturers. While the government had made provision for R250m for the scheme’s first year of operation, it had yet to receive or pay out any claims, said Crisp.
“Last year there was no idea how many and how complex the injuries might be, so the solution was complicated and expensive. Now we know that the numbers are very few,” said Crisp.
An individual or their family can lodge a compensation claim with the scheme only after an investigation by the national immunisation safety expert committee (Nisec) concludes their alleged vaccine injury was caused by a Covid-19 vaccine. Serious health events following vaccination are reported to SA’s medicines regulator, the SA Health Products Regulatory Authority (Sahpra).
By March 18, the government had administered more than 32.2-million coronavirus shots, and Nisec had received 5,566 reports of adverse events following immunisation, according to figures published on Sahpra’s website. The number of such events determined by Nisec to have been caused by Covid-19 vaccines was “far below 100” , with no deaths, said Crisp.
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