Sahpra wants time to make all necessary checks before approving vaccines

Sahpra wants time to make all necessary checks before approving vaccines


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Pretoria – The South African Health Products Regulatory Authority (Sahpra) has pleaded with South Africans to have faith in its methods of approving vaccines, by allowing them to make all the necessary checks and balances before giving the distribution of upcoming vaccines the green light.

The regulatory authority made the plea during a briefing on the status of the registration of Covid-19 vaccines in the country earlier today.

Dr Boitumelo Semete-Makokotlela, the chief executive for Sahpra, said they wanted people to know that they were an independent regulator and that all the decisions made by them were arrived at using science.

She said this was particularly important when dealing with the Covid-19 pandemic as there was constant new scientific data emerging which they had to constantly keep an eye on.

Semete-Makokotlela said they did this so that in the likelihood they needed to change their decision for whatever reason it was still based on science.

She said it was important for the regulator to continue to be stringent with the approval of vaccines because their mandate required that they keep the public's safety of paramount importance.

Even though they understood the urgency for vaccines amid the third wave and had heard the numerous calls made by the public for vaccines to be rolled out speedily, Semete-Makokotlela said it was still important to make science-based decisions not influenced by any pressure.

“The public needs to have confidence in us so that whether they purchase paracetamol or any other medication they continue to do so without wondering at any point if that medication would do what it claims to do at the end of the day.”

“So whether it's the chronic medication, going for an MRI or chemotherapy at no point should there be doubts because our job is to ensure that whatever is contained in that leaflet is what is correct and it details what the contraindications and possible side effects are.”

The regulatory authority announced that they were in the final stages of approving China's Sinovac vaccine as they were at the advanced stage of the evaluation with them having had numerous engagements with the applicants.

The decision for that application would be communicated in the next coming days.

Regarding Russia's Sputnik V vaccine, Sahpra said they were continuing their engagements with the applicant as they had applied for an emergency use application and a rolling review submission, which would allow them to make data available as and when they received it.

Semete-Mokokotlela added that they've had numerous engagements with the applicant and the expectation was that it would now progress quicker as there was a lot of data they had recently submitted to them (Sahpra).

Pretoria News

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