South Africa intends to fast track regulatory approval for Covid-19 vaccines and expects the first applications within a fortnight, says the South African Health Products Regulatory Authority (Sahpra).
In an interview with Reuters, the regulator said the government hopes to receive its first vaccines from the Covax global vaccine distribution scheme in the second quarter of next year.
“Sahpra will prioritise all Covid-19 applications and will apply an expedited approach to health products, including vaccines,” said spokesperson Yuven Gounden.
The expedited method will include a “rolling review approach” where vaccine candidate evaluation is done as data becomes available, he said.
The regulator will rely on guidance from the World Health Organization and work done by international counterparts, such as European and US pharmaceutical regulators, to avoid repeating work already done that could delay approvals.
“We expect the first vaccine applications in the next week or two,” Gounden said.
President Cyril Ramaphosa has said that South Africa is in the process of finalising its process in the Covax facility, which is a resource sharing initiative which will give countries suitable access to several possible vaccines.
“It is anticipated that we could have access to a suitable vaccine by the second quarter of 2021 and will initially receive quantities for at least 10% of the population,” he said in a statement this week.
“While this gives us hope, the reality is that it will take some time before we can vaccinate enough South Africans to be assured of little to no transmission of the virus, and it will be a costly undertaking.
“We need to prepare for this, and be ready to make the difficult decisions about where to find the money and when to deploy it,” he said.
South Africa will probably take its first delivery of coronavirus vaccines by the middle of next year after agreeing on an initial payment, the health ministry said last week.
“Our understanding from the production estimates we have been provided with at this stage is that we should expect to receive the first batch of stock in quarter two of 2021,” the department said.
The government is also considering buying vaccines from other potential producers, including Johnson & Johnson, Novavax Inc, AstraZeneca Plc and the Pfizer Inc and BioNtech partnership.
It needs to ensure it has funds and resources for the distribution, storage and administration of the vaccines, the ministry said.
“While the Covax facility is our favored vehicle for accessing vaccines, we will always explore all options to ensure that the process of rolling out vaccines is safe and cost-effective,” it said.