The South African Health Products Regulatory Authority (SAHPRA) says it will not grant approval to vaccines that do not meet stringent standards and protocols, says chief executive Dr Boitumelo Semete-Makokotlela.
Semete-Makokotlela reaffirmed the stance during the authority’s webinar on the process of vaccine approval on Thursday.
This comes on the eve of a planned march to the SAHPRA offices by the Economic Freedom Fighters, which accuses the authority of not approving the use of the Sputnik V and Sinovac vaccines.
“Where products do comply, we will indeed authorise. We concern ourselves with only science and nothing else,” she said.
She said SAHPRA protocols ensure that the authority takes into account all facts.
“When we make a decision, we don’t only consider data generated from South Africa. We are working with experts – international experts – and we continuously review the emerging data around these vaccines,” Semete-Makokotlela said.
Regarding the march, she said it was the Constitutional right of every South African to protest.
“We just hope and urge the [marchers] to comply with the COVID-19 safety protocols of wearing masks and social distancing.
“Gauteng has high [infection] numbers and we really need to make sure that through non-pharmaceutical interventions, these are managed.”
The regulator’s position, she said, is that decisions are made based on the science that is behind every single vaccine.
“… The types of data we look at [are very] detailed, and the reviews that we go through. Our main concern is the science of these vaccines.
“We are evaluating the Sinovac vaccine. We are also evaluating the Sputnik vaccine. This week, we’ve received an application for Sinopharm. We are really quite busy as an organisation and the only thing we’re going to concern ourselves with is science.
“While the authority understands that this is a pandemic and understands that delays have been experienced, it is important to indicate that the safety of the public is paramount and needs to be safeguarded.
“The safety of the public takes precedence. Wherever we are of the view that the regulatory requirements are not met, we will not issue an authorisation.”
This is due to the SAHPRA’s intent to ensure that when the public gets a vaccine, the authority is confident that the vaccine is safe, said Semete-Makokotlela.
It is a similar stance that was taken on the Johnson & Johnson vaccine, of which two million doses had to be discarded due to manufacturing safety concerns raised in the United States.
“That should actually give the public confidence that as a regulator, while we are cognisant of the pandemic and the pressures that we under, where we are of the view that the safety of the public will be compromised, we will ensure that we remain independent, and we make decisions based on science.
“We will therefore not authorise what does not comply with these pillars,” Semete-Makokotlela said. – SAnews.gov.za
