BOITUMELO SEMETE-MAKOKOTELA: SA medicines regulator streamlines approval process for Covid-19 vaccines

In an effort to enable and support the country’s response in fighting the Covid-19 pandemic, the SA Health Products Regulatory Authority (Sahpra) has put in place a streamlined approach for the expedited review process for Covid-19 vaccines.

Sahpra, as well as other regulators, have agreed on the minimum requirements to be met for the various countries to ensure the processes of reviewing Covid-19 vaccines are expedited. Each country considers the epidemiological context in their respective countries, including the prevalence of diseases such as HIV and TB. An additional critical consideration is vaccine efficacy, and effectiveness against the dominant variants of concern in each country.

To support scientific evaluation of the vaccines, Sahpra established a specialised working group called the Covid-19 Vaccine Registration Working Group comprising both external and internal Sahpra experts in areas of virology, vaccinology, manufacturing, clinical trials, epidemiology, vigilance and other specialisations informing the quality, safety and efficacy of Covid-19 vaccines.

Sahpra has also encouraged applicants to have pre-submission meetings with the regulator, where they are able to share the readiness of data for submission and receive guidance from experts. Sahpra has furthermore published various Covid-19 vaccine guideline documents to guide applicants on the process and requirements. For Covid-19 vaccine authorisations, the expedited processes includes the approaches indicated below, depending on the route of submission by the applicant.

1. If a product has World Health Organization (WHO) emergency use authorisation Sahpra will rely on the review of the product. This does not mean it does not review the dossier, it means questions posed by the WHO and the responses of the applicant will be considered in the review process. Sahpra’s experts also participate in the WHO global joint review of Covid-19 vaccines.
2. Sahpra also takes  into account assessments done by other regulators it is aligned with, such as the US Food & Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, and Australian Therapeutic Goods Administration, to name a few.
3. Lastly, Sahpra allows for rolling reviews of submissions; that is, reviewing data that is available and accepting ongoing data in batches for review.

This expedited review process is also dependent on the timeous submission of the required data, and the adequacy of responses to the queries raised by Sahpra to the applicant. Thus, the full review process also takes into account the time taken by applicants to satisfactorily respond to queries from Sahpra.

The Sputnik V application is currently under review by Sahpra, including by the WHO for emergency use authorisation, and by the European Medicine’s Agency. The submissions of the Sinopharm vaccine, which already has WHO emergency use authorisation, is also under evaluation by Sahpra.

• Dr Semete-Makokotlela is Sahpra CEO.