Decision on Coronavac vaccine at advanced stage, says medicines health regulator

The prospects for a wider access by SA to a variety of vaccines may be looking brighter as the health products regulator's review of the Chinese Coronavac vaccine is at a “very advanced stage” and it is also conducting a rolling review of the Russian Sputnik vaccine.

The SA Health Products Regulator (Saphra) has so far approved the Pfizer and the Johnson & Johnson vaccines. Both vaccines were used for the Sisonke programme to vaccinate health workers but the supply of J&J vaccines was held up as a result of their contamination at a US plant.

In a statement Sahpra said applications for approval had been received for the Coronavac vaccine manufactured by Sinovac and the Sputnik V manufactured by Gamaleya Research Institute.

“The evaluation of the Coronovac application is at a very advanced stage. Furthermore, reports recently made available by the World Health Organisation (WHO) that articulate the basis for the emergency use listing are being considered,” Sahpra said. “The Sputnik V application is a rolling review, thus as data becomes available to the applicant it is submitted to Sahpra.”

An emergency use listing of a vaccine by the WHO gives the green light for its use to be rolled out globally. It allows countries to expedite their own regulatory approval to import and administer the listed Covid-19 vaccines.

Before an emergency use listing, a panel of experts assesses the quality, safety and efficacy of the vaccine, as well as its risk management plans and programmatic suitability, such as cold chain requirements. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The statement said that Sahpra could not approve any product if an application has not been submitted to the authority. No applications had been made for the Sinopharm and Moderna vaccines so no decision had been made on them even though they have a WHO emergency use listing.

The WHO has listed the Sinopharm vaccine produced by Beijing Bio-Institute of Biological Products, a subsidiary of China National Biotec Group for emergency use.

Now that the J&J vaccine has overcome its contamination problems, supplies have begun to flow into SA. A total of 300,000 doses arrived last Thursday for the vaccination of 582, 000 teachers and staff in the education sector. This week 1.2-million J&J doses are due to arrive as well as 1.274-million Pfizer vaccines.

Next week, a further 1.39-million Pfizer vaccines are expected and the following week 190,710 Pfizer vaccines through the Covax facility, a global initiative to supply countries with vaccines. The Pfizer vaccine requires two doses.

These figures were provided last Thursday by the department of health’s Nicholas Crisp — who is heading up the vaccination programme — at a media briefing. He also gave a perspective of the vaccine acquisition programme for the rest of the year. He said that in quarter three from July to September, 9.1-million J&J vaccines and 16.5-million Pfizer vaccines were expected. The figures for quarter four from October to December were 19.1-million J&J vaccines and about nine-million Pfizer vaccines. The total for the last three quarters of the year would be 31-million J&J vaccines and 30-million Pfizer vaccines.

SA has had a series of hiccups in its acquisition of vaccines. The first batch to arrive was one-million doses of the AstraZeneca vaccine in February from the Serum Institute of India. A week later a trial found they were not effective against the SA variant of Covid-19 and the government sold the vaccine to the AU in March.

The first J&J vaccines also arrived in February but in April the use of this vaccine was paused due to reports of it causing rare blood clots. Once this problem was overcome, J&J vaccine production was hit by the contamination of its vaccines at a plant in Baltimore in the US, and as a consequence SA had to destroy two-million doses at its Gqeberha plant of Aspen Pharmacare.

ensorl@businesslive.co.za