A photo shows empty bottles of Pfizer-BioNTech Covid-19 vaccine at the Emile Muller hospital in Mulhouse, eastern France, on January 8, 2020. (Photo by SEBASTIEN BOZON / AFP)
One of the country’s top medical researchers Professor Helen Rees says in a worst-case scenario, current Covid-19 vaccines could be ineffective against variants detected across the globe – including the one found in South Africa.
Rees, board chairperson of the SA Health Products Regulatory Authority (SAHPRA), and officials briefed Parliament on the country’s vaccine approval process as well as the use of ivermectin.
On Wednesday, Rees told the legislature’s health committee that local and international scientists were hard at work conducting research on the variants.
“We have this variant in South Africa, and we are deeply concerned that this variant will affect the efficacy of some of our vaccines.
“Outstanding local researchers and global researchers are working very hard to look at what is the impact of the variant in terms of the effectiveness of that vaccine.
“At its worst, it can really make some of these vaccines ineffective… at its worst. We are hoping that will not be the case,” she said.
Rees said vaccine manufacturers were looking at variants found recently in the UK, US and Brazil.
“They are looking at how quickly they can change their vaccine if this variant is shown to not be as responsive to the original vaccines that were developed. That data comes in all the time. Regulators have to think about this data all the time,” Rees said.
SAHPRA also gave an update on its decision to allow for the controlled use of ivermectin in Covid-19 patients.
In January, the regulator released guidelines on its controlled, compassionate user programme for the use of ivermectin in Covid-19.
SAHPRA CEO Boitumelo Semete said that given the unavailability of data that indicated clinical benefit nor harm that can be caused, SAHPRA resolved to make ivermectin available under a controlled programme.
“The overall quality of the randomised trials involving ivermectin in Covid-19 patients is extremely low.
“Overall trend is positive, however the data is insufficient to enable a regulator to make a decision. SAHPRA encourages that clinical trials be conducted in SA,” she said.
Under SAHPRA’s programme: Only registered medical practitioners may apply for permission to prescribe ivermectin to a patient and if approved, the practitioner must comply with all reporting requirements related to a Section 21 approval.
As ivermectin for human use is not available in the country it will need to be imported.
Authorisation to import ivermectin will only be issued to registered applicants who hold a relevant license.
Licensed facilities may apply to hold emergency stock of ivermectin, which must be obtained by an authorised importer.
Rees said the data around ivermectin “will come in all the time”.
“We were thinking of ivermectin for months. Not just because of any court case, we have looked at the data, we have had meetings on it way before there was any court case.
“Our conclusion, having listened to both sides, was indeed to go the middle route,” she said.
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