- South Africa is swiftly moving towards setting up a no-fault compensation scheme for Covid-19 vaccination, which would remove a major roadblock for manufacturers.
- But many questions remain around the exact mechanism by which government would pay for vaccine injuries, so removing all risk for vaccine makers and those who administer jabs.
- People older than 60 can now put themselves on the list for vaccination
- Vaccines from China and Russia are currently undergoing tests for registration by the South African Health Products Regulatory Authority.
- For more articles, go to www.BusinessInsider.co.za.
One major roadblock to a mass rollout of Covid-19 vaccines in South Africa has started moving out of the way, with a draft plan published for the Covid-19 Vaccine Injury No-Fault Compensation Scheme.
The scheme, and an associated fund, was demanded by vaccine manufacturers. It will make them immune to any damages claim in the event of vaccine injury, and will also prevent claims against those who administer jabs. If anything does go wrong, causing serious injury or death, all claims will be against the government only.
The plan leaves out many details, though, including who would be compensated, how much they would be paid, how they would go about claiming, and who will ultimately run the scheme.
See also | SA now has a rough plan to deal with injury claims from Covid vaccines. Companies won't be liable
In the meanwhile, registration for vaccinations opened for people older than 60 on Friday. The expansion to the Electronic Vaccination Data System – which was previously reserved for frontline healthcare workers – is in preparation for Phase 2 of the rollout.
That phase aims to vaccinate more than 16 million people, even as the first phase lags behind, with fewer than 300,000 healthcare workers vaccinated out of a targeted 1.2 million.
South Africa’s use of the Johnson & Johnson (J&J) vaccine is due to restart on Wednesday 28 April after a two-week pause amid concerns around blood clotting reported in the United States (US). The decision to continue using the J&J doses for the remainder of Phase 1 of the rollout was confirmed by Health Minister Zweli Mkhize following a recommendation by the South African Health Products Regulatory Authority (SAHPRA).
The real-world Phase 3b clinical trial of the J&J vaccine was swiftly authorised following South Africa’s decision to abandon the rollout of the AstraZenecajab in February. The vaccine, procured from the Serum Institute, showed diminished efficacy against the 501Y.V2 variant prevalent in South Africa.
South Africa sold its consignment of AstraZeneca doses to the African Union and received a refund from the Serum Institute for vaccines ordered but not yet delivered.
And while the setbacks associated with both the AstraZeneca and J&J jabs are worrisome against the backdrop of South Africa’s already sluggish vaccine rollout, Mkhize says that the latest suspension is unlikely to result in significant delays to the country’s phased approach.
Mkhize pointed to the imminent arrival of vaccines produced by Pfizer as part of government’s procurement plan.
Here’s where South Africa’s vaccine authorisation, procurement and rollout plan currently stands.
Johnson & Johnson: ordered 31 million doses. Approved
All vaccine doses administered in South Africa up to 14 April were developed and produced by J&J. This vaccine is preferred due to its one-shot dose – while all other vaccines require at least two shots – and its standard storage requirements. The J&J vaccine can be stored at between 2°C and 8°C for three months.
It was officially registered by SAHPRA for widespread use in South Africa on 31 March 2021.
South Africa has secured a further 30 million doses of the J&J vaccine, which are being produced by Aspen Pharmacare in Gqeberha. The first batch of these SAHPRA-approved doses are due to arrive in the third week of April.
The J&J vaccine has been shown to be 66% effective in preventing mild to moderate disease and 85% effective in preventing severe disease associated with Covid-19. The vaccine has a 64% efficacy rate at preventing the more contagious 501Y.V2 variant, according to the FDA.
Its use in South Africa and the US was suspended on 13 April due to concerns around the formation of blood clots. The suspension was lifted two weeks later, with J&J doses administered from 28 April.
Oxford-AstraZeneca – suspended
The Oxford–AstraZeneca vaccine, sold under the brand name Covishield, was the first vaccine procured by South Africa through the Serum Institute of India. The first batch of one million doses arrived in the country on 1 February, with a further 500,000 jabs scheduled to arrive later that month.
The proposed rollout was, however, halted just a week after the vaccines touched down in South Africa. Results from AstraZeneca’s South African trial conducted among 2,000 participants showed low efficacy against mild and moderate disease, below 25%, caused by the 501Y.V2 variant.
A recent phase III clinical trial put the two-dose vaccine’s overall efficacy at 76% and has divided opinion regarding South Africa’s decision to abandon the AstraZeneca jab.
Use of the AstraZeneca jab remains suspended, and no further orders have been placed with the Serum Institute.
Pfizer-BioNTech: ordered 30 million doses. Approved
The mRNA-based Pfizer-BioNTech was approved for use in South Africa by SAHPRA on 16 March 2021. The two-dose vaccine has been shown to be 95% effective in an ongoing large-scale clinical trial, according to the World Health Organisation (WHO).
“In South Africa, where the 501Y.V2 lineage is prevalent and 800 participants were enrolled, nine cases of Covid-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%,” noted Pfizer in announcing the results of its latest phase III trial on 1 April 2021.
South Africa has ordered 30 million doses of the Pfizer vaccine – with 20 million doses already paid for – to fast-track the rollout. The first batch is due to arrive in the first week of May 2021.
Mkhize estimates that 6.5 million doses will arrive between May and June, while 16.5 million doses will be distributed between July and September. The remaining seven million doses will arrive in South Africa between October and December.
One challenge with the Pfizer jab, however, is that it needs to be stored at temperatures between -80°C and -60°C, far colder than the requirements of any other vaccine.
COVAX: allocated 2.5 million doses. Approved
The Covid-19 Vaccines Global Access programme – abbreviated as COVAX – is an initiative spearheaded by the WHO, which is aimed at ensuring equal access to vaccines, especially in developing nations.
The programme is funded by first-world countries and private-sector philanthropists. A total of 92 low and middle-income countries are inline to receive vaccines through donor-funded COVAX facility. South Africa is one of these countries.
The first batch of COVAX-acquired vaccines have already been allocated to various countries and are due to be delivered before May 2021. COVAX currently supplies vaccines produced by Pfizer and AstraZeneca.
South Africa is due to receive 117,000 doses of the Pfizer vaccine, according to the latest COVAX allocation document. Neither COVAX nor Mkhize have indicated when these doses will arrive.
South Africa has received a further allocation of 2,426,400 doses of the AstraZeneca vaccine. Due to the suspension of the vaccine’s use in South Africa, COVAX notes that these doses may be reallocated to other countries.
Sputnik V – being reviewed by SAHPRA
The viral vector Sputnik V vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia, is currently awaiting approval from SAHPRA.
The two-dose vaccine has been shown to be 91.6% effective in combatting Covid-19 but has a diminished efficacy against the 501Y.V2 variant.
“With regards to the ‘South African’ variant, the effectiveness of the antibodies produced by Sputnik V, like all other vaccines, against it declines,” explained Alexander Gintsburg, head of the Gamaleya Institute, on 9 April 2021.
While waiting approval from SAHPRA, no orders for the Sputnik V vaccine have yet been placed.
Sinovac – being reviewed by SAHPRA
The Sinovac vaccine – also known as Coronavac – is produced by the Chinese company Sinovac Biotech. A recently completed phase III study showed that the vaccine was only 50.4%% effective in combatting Covid-19.
SAHPRA confirmed that it had received documentation for the Coronavac vaccine developed by Sinovac on 10 March 2021 and is in the process of evaluating the jab’s potential use in South Africa.
Moderna - not submitted to SAHPRA
The Moderna Covid-19 vaccine was touted as being part of South Africa’s “immediate” rollout in February.
Developed by the United States National Institute of Allergy and Infectious Diseases (NIAID), the vaccine has shown to be 90% effective against all forms of the disease and 95% effective against severe disease.
Moderna is also developing a vaccine to specifically target the 501Y.V2 variant. According to reports, early trials of a Moderna vaccine specificall targeting the SA Covid variant has produced antibodies in mice.
But, as of 14 April 2021, Moderna has made no submission to SAHPRA and, according South Africa’s parliamentary Adhoc Committee on Covid-19, is unlikely to do so before the third quarter.
(Additional reporting by Phillip de Wet)