Chinese coronavirus vaccine manufacturer Sinovac Biotech has offered to supply the government with 5-million doses of its CoronaVac shot, which could be provided within weeks, its local partner Numolux said.
Last week, health minister Zweli Mkhize said the government might miss its target of vaccinating 40-million people by the end of the year because of tight supplies, putting the country, which has the worst recorded Covid-19 caseload in Africa, at a greater risk of new waves of infections that lead to economically damaging lockdowns.
The economy slumped into its biggest drop of annual GDP in 2020 since records began and the country lost more than 1-million jobs.
Sinovac’s promise of swift delivery comes as the government faces delays in obtaining the vaccines committed by Johnson & Johnson (J&J) and Pfizer, most of which are only expected in the second half of the year. Sinovac’s vaccine has yet to be given the green light by SA’s medicines regulator, but once that hurdle is cleared a shipment could land in SA within “two to three weeks”, according to Numolux CEO Hilton Klein. Numolux licensee Curanto Pharma applied to the SA Health Products Regulatory Authority (Sahpra) last week for full registration, as well as emergency-use section 21 authorisation, which enables doctors to administer unregistered medicines approved by other regulators. Klein declined to disclose the price of the vaccines offered.
Applications to register new products with Sahpra typically take months, or even years, but section 21 authorisations can fast-track this. The health department’s section 21 authorisation to import AstraZeneca vaccines from the Serum Institute of India was approved by Sahpra in two weeks.
Pfizer’s section 21 go-ahead for its Comirnaty Covid-19 vaccine was granted earlier this week, six weeks after it submitted its application. Its application for full registration, submitted in early January, is still pending.
Sinovac’s vaccine requires
two doses, administered two weeks apart, and uses inactivated Sars-CoV-2 to prompt the body’s immune system to make antibodies to the virus. Separate phase 3 trials in Brazil and Turkey reported that it offers protection against Covid-19, but the results are difficult to compare because the trials were designed differently.
The trial in Brazil found it had an efficacy of about 50%, while the one in Turkey showed 83% efficacy.
The company has yet to publish the data in a medical journal, but its vaccine has been approved in China and several countries have begun administering it under emergency authorisation, including Brazil, Mexico, Indonesia, Turkey, Thailand, Malaysia and Zimbabwe.
The health department has signed an agreement with J&J for 9-million doses of its singleshot vaccine, with scope to purchase 20-million more.
It is also poised to sign a deal with Pfizer for 20-million doses of its two-dose vaccine.
Mkhize 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.
However, the health department has only been provided with a quarterly breakdown of the rest of the vaccines committed by Pfizer, with 5-million shots due between April and June; 7.6-million between July and September; and 7-million in the last quarter of the year.
It similarly has only a quarterly breakdown for the J&J vaccines: 3-million will arrive between April and June; 4-million between July and September; and 4-million between October and December, Mkhize said at the time.
Both the J&J and Pfizer deals have involved extensive negotiation as the government wrestled with the requirements set out by vaccine manufacturers.
A presentation by the health department to the cabinet on January 28 flagged some of the challenges it said it was facing with contracts proposed by vaccine manufacturers, including requirements that they be absolved from all product liability and face no penalties for failure to deliver on time.