CAPE TOWN (Reuters) – South Africa has given fast-track approval to AstraZeneca’s COVID-19 vaccine for emergency use and is reviewing applications by rival manufacturers Pfizer and Johnson & Johnson, the medicines regulator said on Wednesday.
As the country prepares to roll out a massive vaccination programme, South African Health Products Regulatory Authority (SAHPRA) chairwoman Helen Rees said: “In terms of the AstraZeneca vaccine … this has been granted emergency use (approval).”
South Africa has suffered a surge in infections driven by a new, more contagious variant of the virus called 501Y.V2, which drove daily new cases to 21,000 in early January, although they have now eased to below 10,000.
The government has agreed to pay $5.25 per dose for 1.5 million shots of AstraZeneca’s coronavirus vaccine produced by the Serum Institute of India (SII) which are expected to arrive this month and next. The shots will be used to protect frontline workers.
The health department said on Friday that SAHPRA had approved a Section 21 authorisation recognising it as the supplier of the SII vaccine. Normally valid for six months, a Section 21 authorisation is an instrument for emergency use access of a product that is unregistered, SAHPRA officials said.
Health minister Zweli Mkhize is expected to hold a news conference at 1800 GMT on Wednesday.
Speaking at the same media briefing as Rees, SAHPRA’s chief executive Boitumelo Semete-Makokotlela said further information was needed before J&J’s application could be approved.
The U.S. company was the first supplier to apply for registration in South Africa, in December, but has not yet published results of its vaccine’s Phase III clinical trials.
It said on Tuesday it expected to report the data early next week, and that it would be able to meet the delivery target for doses to countries with which it had signed supply agreements.
“These ones in particular are at a very advanced stage of Phase III studies wherein we’ve got initial data that indicates their safety and efficacy,” Semete-Makokotlela said, referring to the J&J vaccine.
“We are still at that point with J&J where additional information is still required.”
She said the regulator had held a number of pre-submission meetings with applicants, including suppliers from China and Russia.
The National Treasury said on Wednesday it could cost South Africa between 20 billion and 24 billion rand ($1.3 billion to $1.6 billion) to vaccinate around 40 million people against COVID-19.
A Pfizer spokesman did not want to divulge how many doses of the vaccine it developed with German partner BioNTech may be allocated to South Africa.
“Our discussions with both the government of South Africa and the African Union are ongoing, but details of these remain confidential,” he said.
Public health officials are increasingly counting on single-dose options like the one being tested by J&J to simplify and boost inoculations given the slower-than-hoped rollout of authorised vaccines that require a second shot weeks later.
On Wednesday, South Africa’s opposition Democratic Alliance (DA) announced court action to force President Cyril Ramaphosa’s government to release details of its COVID-19 vaccination plans.
(Reporting by Wendell Roelf; Editing by Catherine Evans)
