THE SA Health Products Regulatory Authority (Sahpra) says applications for the Chinese manufactured CoronaVac and the Russian Sputnik V Covid-19 vaccines have been received and were currently under review.
So far, the regulator has approved AstraZeneca, Pfizer and the Johnson & Johnson (J & J) vaccines.
Sahpra has now said that it has also received applications for CoronaVac (manufactured by Sinovac) and the Sputnik V (manufactured by the Gamaleya Research Institute) vaccines.
“The evaluation of the CoronoVac application is at a very advanced stage. Reports recently made available by the World Health Organization (WHO) that articulate the basis for the emergency use listing for CoronaVac are being considered,” the regulator’s chief executive, Dr Boitumelo SemeteMakokotlela, said.
The Sputnik V application was a rolling review. Thus, as data became available, it was submitted to be reviewed.
Semete-Makokotlela said they had fast-tracked all Covid-19 product reviews and, like other countries, approved products on an emergency-use basis with product specific requirements for ongoing monitoring.
In an effort to respond to the pandemic, Sahpra had introduced another mechanism to facilitate review of Covid-19 applications, which was the rolling review process.
“This is a mechanism that facilitates the submission of data as it becomes available. While reviews can commence earlier with a rolling submission, it is important to note that efficacy, quality and safety information is sometimes outstanding and would require review for consideration of such products for public use,” Semete-Makokotlela said.
When an applicant submits their respective dossiers, the regulator works closely with the applicant in evaluating the data.
The watchdog organisation also works closely with other regulators across the world, as well as with the WHO in assessing the quality, safety and efficacy of health products, and in this case, Covid-19 vaccines.
The regulator only reviews products submitted by a local applicant. If no application has been submitted, no regulatory review can be undertaken.
Thus, there is no decision on, for example, Sinopharm and Moderna vaccines – which have a WHO emergency-use listing – as there have not been any applications for these in
South Africa.
Semete-Makokotlela said, in considering whether or not a vaccine introduced into South Africa was likely to be effective, they take into account the local epidemiology, and specifically which SARS-CoV-2 variants were circulating in the country.
“All the Covid vaccines currently being used worldwide have been shown to be effective against the original Wuhan variant. However, all these vaccines are less effective against the SARS-CoV-2 variants of concern that have emerged in the past nine months.”
She explained that in South Africa’s third wave, the beta variant of concern was responsible for over 95% of infections.
For this reason, the regulator was asking vaccine applicants to provide laboratory and clinical studies supporting claims about vaccine efficacy when used in the context of the beta variant of concern.
If this data is not available, the regulator asks applicants to generate such.
In addition, it is working with the expert academics to develop a national protocol to monitor the effectiveness of all vaccines introduced as part of the roll-out.
“We are committed to prioritising all Covid-19 health products, including vaccines, as the world and South Africa grapple with ending the scourge of a pandemic of mammoth proportions.”
Semete-Makokotlela said they would not be pressured into allowing the public access to any product that had not met the necessary regulatory requirements.
Pretoria News
Credit IOL