POLITICS

Russian & Chinese vaccines being evaluated - SAHPRA

Coronovac application at advanced stage, Sputnik V application is a rolling review

SAHPRA UPDATE ON VACCINE APPROVALS

21 June 2021

SAHPRA as an independent health products regulatory authority focuses on the three pillars of quality, safety and efficacy. These core elements of its mandate also apply to COVID-19 vaccines as well.

The normal process for the evaluation of a vaccine, necessitates that all the required information regarding product safety, efficacy and quality be provided at the time of submission. In other words, all the clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality. The assessment is then conducted considering all information provided.

In an effort to respond to the pandemic, SAHPRA introduced another mechanism to facilitate review of COVID-19 applications, which is the rolling review process. The rolling review is a mechanism that facilitates the submission of data as it becomes available. Whilst reviews can commence earlier with a rolling submission, it is important to note that some very important efficacy, quality and safety information is sometimes outstanding and would require review for consideration of such products for public use. Therefore, Pharmaceutical companies can submit applications indicating a plan of when they will be submitting their data, i.e outline when the next rolling submission sequence is available for review.

When an applicant submits their respective dossiers, SAHPRA works closely with the applicant in evaluating the data. Technical, subject matter experts within SAHPRA and external members that are appointed by the CEO, comprise the team that evaluates these applications. SAHPRA also works closely with other regulators across the world as well as with the World Health Organisation (WHO) in assessing the quality, safety and efficacy of health products, and in this case, COVID-19 vaccines.

Thus far, SAHPRA has approved the Pfizer and the J&J vaccines. SAHPRA 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. Furthermore, reports recently made available by the WHO that articulate the basis for the Emergency Use Listing are being considered. The Sputnik V application is a rolling review, thus as data becomes available to the applicant it is submitted to SAHPRA.

SAHPRA cannot approve any product if an application has not been submitted to the authority. Thus, there is no SAHPRA decision on Sinopharm and Moderna vaccines which have a WHO Emergency Use Listing, as there have not been any applications for these vaccines in South Africa.

Of concern is the prevalence of variants of concern such as the beta variant in South Africa. This requires that SAHPRA ensure efficacy against such variants and hence information on studies supporting efficacy would be expected to be provided by the applicant.

“SAHPRA is committed to prioritising all COVID-19- related health products, including vaccines, as the world and South Africa grapples with ending the scourge of a pandemic of mammoth proportions. SAHPRA will not be pressured to allow the public access to any product that has not met the necessary regulatory requirements,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Statement issued SAHPRA, 21 June 2021