South Africa's drugs regulator SAHPRA has announced that it had approved a conditional "section 21" emergency use application for the COVID-19 vaccine developed by Pfizer and BioNTech. According to Business Report, SAHPRA added that the approval was subject to further efficacy and safety surveillance of the vaccine in the country, including monitoring its efficacy against the dominant local coronavirus variant.
South Africa is the hardest-hit country on the African continent in terms of recorded coronavirus cases and deaths and suffered a severe second wave of infections driven by the more infectious 501Y.V2 variant, first identified late last year.
It kick-started its vaccination campaign with Johnson & Johnson's one-dose vaccine last month in a research study targeting up to 500,000 health workers.
But it has so far administered only 150,000 doses of the Johnson & Johnson vaccine, lagging wealthier nations on other continents that have already vaccinated millions of their citizens.
The government says it has secured 20m doses of the two-dose Pfizer-BioNTech vaccine in bilateral negotiations, with deliveries ramping up from the second quarter of the year. It also hopes to receive 117,000 doses of the Pfizer-BioNTech vaccine before the end of the month from the COVAX facility, the global vaccine distribution scheme co-led by the World Health Organisation and partners including the Gavi vaccines alliance.
The approval is dependent on the guarantee of more safety and efficacy surveillance of the vaccine in South Africa. Daily Maverick reports that this will include how it fares against the variant 501Y.V2.
Pfizer and BioNTech applied for their vaccine to be approved through Section 21 of the Medicines and Related Substance Act, Act 101 of 1965. This allows for unregistered products to be sold in South Africa. The person who sells the medicine has to provide regular safety updates and progress reports on the use of the medicine to SAHPRA.
There are three ways in which South can legally roll out vaccines, said the co-chair of the Ministerial Advisory Committee on COVID-19, Professor Salim Abdool Karim in the DM report.
The first is when a Phase Three study is used – this is an implementation study and no placebo is used because the vaccine is known to be efficacious and real-world effectiveness is being tested. This is how the Johnson & Johnson vaccine is being rolled out.
“The research component of this is actually quite small, so it’s really a roll-out programme, but it’s done in the context of research,” Karim said.
This has the added benefit of being able to closely monitor safety, but it has limitations. Because there is a research component, only individuals approved by Sahpra can dispense the vaccine.
The second roll-out option is through a Section 21 approval. “This is quite a restricted approval because you can only use the vaccines in the way in which you have applied for and the number of doses applied for,” Karim said. The big advantage of this is that any pharmacist can dispense this vaccine.
The final option is full registration, which has no restrictions. The product is dispensed according to the schedule.
“Once you have a Section 21, you can really start ramping up,” DM quotes Karim as saying. The Pfizer vaccine is expected in South Africa in April, so the next few weeks are likely to be spent getting the system “up and running” to handle the cold-chain requirements of this vaccine.
While SAHPRA’s announcement means a key regulatory hurdle has been cleared, it still remains an open question when Pfizer’s vaccines will arrive in South Africa, says a BusinessLIVE report. The Health Department is poised to sign an agreement with Pfizer after it obtained special permission from the cabinet last week to agree to the pharmaceutical manufacturer’s terms, but, the report says, there there is still no clarity on exactly when shipments will land in South Africa.
The report says the Health Department had not responded to questions at the time of publication, but Health Minister Zweli Mkhize has previously indicated the government had secured 20m doses of Pfizer’s two-shot vaccine.
He told parliament last week that 600,000 doses of Pfizer’s vaccine were expected by end-March, about 100,000 of which were to be sourced from the international vaccine financing vehicle COVAX.
But, the report says, the Health Department had only been provided with a quarterly breakdown of the rest of the vaccines committed by Pfizer, with 5m shots due between April and June, 7.6m between July and September, and 7m in the last quarter of the year.
Full report in Business Report (Open access)
Full Daily Maverick report (Open access)
Full BusinessLIVE report (Open access)