The South African Health Products Regulatory Authority (Sahpra) clarified on Monday that it cannot be influenced by political pressure to approve Covid-19 vaccines without adherence to the critical components of safety, quality and efficacy.

This could compromise public safety, the authority said.

In June the Economic Freedom Fighters marched to the Sahpra office calling for the use of Russia’s Sputnik V and China’s Sinovac vaccines. The Sinovac vaccine CoronaVac was later approved for use in the country with conditions.

Sahpra CEO Boitumelo Semete explained that the safety of the public was the most important priority for the regulator, which consistently applied its guidelines, regulations and rules.

Semete added that the medicines approval process entailed a rigorous process of assessment, where all information provided by the applicant was carefully evaluated by experts in their respective fields.

So far, Sahpra has approved the use of the AstraZeneca, Pfizer and the Johnson & Johnson vaccines in South Africa.

“While Sahpra has drastically reduced our usual time frames for the registration of Covid-19 vaccines, it has not cut back on the regulatory requirements to ensure that all these health products are safe and effective. Sahpra will not compromise on the safety of South Africans and will not endanger South African lives,” Semete said.

She further explained that Sahpra considered local epidemiology when making decisions.

Applicants have to provide data demonstrating vaccine efficacy against the variants of concern to Sapra. Therefore, a key contributor to the approval time frame was whether or not this data was readily available from the applicants.

Furthermore, Semete explained that the Sahpra board, which is appointed by the Minister of Health, was not involved in operational matters of the regulator, adding that all regulatory and operational decisions were the responsibility of the Sahpra CEO.

She said the chairperson of the board, Professor Helen Rees, did not act alone in terms of board decisions, but reflected a collective decision by the entire Sahpra board.