SA’s medicine regulator expects to make a decision on Chinese pharmaceutical company Sinovac’s Covid-19 vaccine within a matter of days, it said on Thursday.
Clearance from the SA Health Products Regulatory Authority (Sahpra) is vital, as the health department has indicated it will only enter into new negotiations with vaccine manufacturers if their products have been approved. While the government has already ordered millions of doses from Pfizer and Johnson & Johnson for its national inoculation programme, it has not closed the door on negotiations with other players.
The World Health Organisation approved Sinovac for emergency use in June, saying it prevented symptomatic disease in 51% of those vaccinated, and protected 100% of the studied population from severe Covid-19. But there are lingering questions about the shot’s efficacy. Indonesian officials recently reported dozens of healthcare workers who received the Sinovac vaccine were admitted to hospital. Chile has seen a sharp spike in cases despite having inoculated a large percentage of its population with the shot.
Sinovac’s local representative, Numolox, has offered to supply the government with five-million doses of its two-dose vaccine. It has applied for emergency-use authorisation and full market registration for the jab, branded CoronaVac.
Numolox compliance head Anton Arendse said the company had received correspondence from Sahpra indicating a decision would be made by early next week. “Sinovac has indicated they are able to ship as early as mid-July, contingent of course on Sahpra approval and discussions with the department of health,” he said.
Sahpra received additional data from the applicants for the Russian Gamaleya Institute’s Sputnik V vaccine earlier this week, which is expected to expedite the review process.
Lamar International CEO Jerome Smith said its offer to supply the government with 15-million doses of Sputnik V still stood. Lamar submitted its application to Sahpra five months ago, and is seeking both emergency-use authorisation and full market registration for the shot, he said, declining to discuss pricing.
Lamar International operations manager Naz Gamieldien said the first shipment of Sputnik V vaccines could potentially be shipped to SA in July.
Sahpra CEO Boitumelo Semete-Makokotlela said the regulator had “drastically reduced” its usual time frames for registration of Covid-19 vaccine, but had not cut back on the checks required to ensure the products were safe and effective. The vaccine registration process had previously taken about 20 months, and now took on average 90 working days, she said.
The regulator has come under intense pressure to approve Chinese and Russian coronavirus vaccines from the EFF, which marched on its offices last Friday and threatened a sit-in if it did not clear the shots within a week.
Sahpra has so far approved coronavirus vaccines made by Pfizer-BioNTech, Johnson & Johnson and AstraZeneca.
It said it received an application from Chinese pharmaceutical manufacturer Sinopharm for its Covid-19 vaccine last week.
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