Regulator rejects vaccine pressure

The South African Health Products Regulatory Authority (Sahpra) says it will not be pressured to allow the public access to any product that has not met the necessary regulatory requirements.

So far, Sahpra has approved the Pfizer and the J&J vaccines and also received applications for Coronavac (manufactured by Sinovac) and the Sputnik V (manufactured by the Gamaleya Research Institute) vaccines.

It is in no position to approve the use of Sinopharm and Moderna vaccines in the country because an application for their review has not been submitted, it said yesterday.

Sahpra was responding to public questions on why other vaccines are not being used in the country amid the slow vaccine roll-out as the country battles the third wave of Covid-19.

Gauteng is the hardest hit province in the country, with the number of new cases this week exceeding the peak in previous waves. As a result, hospitals are reaching capacity and healthcare workers struggling. The provincial government has brought in SA National Defence Force medics in to assist in hospitals.

Meanwhile, the Economic Freedom Fighters will on Friday march to Sahpra head office in Tshwane to demand vaccines.

“We demand Sahpra finalise the approval and authorisation of Sputnik V and Coronavac within seven days,” it said.

While the evaluation of the Coronovac application was at an advanced stage, the Sputnik V application is a rolling review and as data becomes available to the applicant, it is submitted to Sahpra, the health body said.

Last week, Sahpra chair Prof Helen Rees said they were waiting for more information about the Sputnik V vaccine to properly review it. “There were two applicants and what they’re doing is called a rolling review. As they get data, they submit it to Sahpra and we’re reviewing that data on a continuous basis,” Rees said.

“This speeds things up because we’re not getting a huge file of information that the regulator has to suddenly try and evaluate. They’re still submitting some of that data, so we don’t have all the data that’s required for a complete review yet.

“What we have to do in the case of the vaccines is to ensure they are safe, of good quality and manufactured properly so that by the time they arrive in the country, they still have a very good standard and they are effective.”

The other concern, according to Sahpra, was the prevalence of variants of concern such as the beta variant in the country.

“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.”