‘We are sitting with quite a healthy pipeline of Covid therapies that are either in review or have already been approved,” South African Health Products Regulatory Authority (Sahpra) CEO Boitumelo Semete-Makokotlela told a webinar on Monday.

The purpose of the webinar was to provide an update on the latest Covid-19 therapy trends and to reiterate the facts of their safety and efficacy to mitigate against fake news and vaccine hesitancy.

“What you’ll see in what I would call ‘the bucket’ of the available therapies that are currently under investigation… you’ll find a lot of antivirals, which is the likes of remdesivir, molnupiravir etc, and then you also see a class of monoclonal antibodies that have also been submitted,” said Semete-Makokotlela.

“We have remdesivir, that was approved with conditions and the applicant here was Gilead. We also have… the generic form of the drug, registered also with conditions,” said Semete-Makokotlela.

Section 21 of the Medicines and Related Substances Act is used to authorise medicines and medical devices that are not registered by Sahpra but are needed based on clinical data. A healthcare professional or the National Department of Health would be a typical applicant and authorisation would be for a specific period and institution with specific quantities.

Semete-Makokotlela said as a result of supply challenges for remdesivir, there were companies that had applied for registration under section 21 and had also applied for registration from Sahpra.

“For us as a regulator, the ideal is that every product must be registered, it then enables access and continuous monitoring of the product,” she said.

“There is also baricitinib, which has been authorised and this is a drug that had been registered for other indications in the past and then these other indications have been added,” Semete-Makokotlela said. 

Last week the treatment molnupiravir was authorised under section 21. Sahpra is reviewing molnupiravir casirivimab/imdevimab, molnupiravir, amphotercin B and nirmatrelvir for authorisation.

Semete-Makokotlela noted that several drugs are being repurposed in the sector, which she said typically happens where the broad-acting drugs are considered for other indications but are still put through the regulatory process.

The Sahpra CEO said the regulator made its decisions based on scientific evidence and also took into consideration the decisions and assessments of other international regulators like the US Food and Drug Administration and the European Medicines Agency.

Some therapies have not been authorised. Semete-Makokotlela said that was because “the data that was made available to us was not sufficient for us to confidently say it can then be utilised for that indication. An example of that is ivermectin, favipiravir, convalescent plasma, as well as medicinal cannabis”.

The Covid-19 vaccines under conditional registration are Pfizer, J&J and Sinopharm. The conditions are about monitoring the vaccines’ safety, implementing their risk management plan, reporting to Sahpra as the regulator, and constant monitoring and evaluating of their efficacy against any emerging variants of concern.

The Sinovac vaccine has a section 21 authorisation and under review were vaccines such as Sputnik because of safety concerns.

Professor Andy Parish, the head of internal medicine at Walter Sisulu University, reminded the webinar that Sahpra decides whether to register drugs while the Department of Health decides whether to purchase them.

Parish, who also chairs the National Essential Medicines List Committee (NEMLC) Therapeutic Guidelines Sub-Committee for Covid-19, said when a product is registered it has to still go through the NEMLC. 

He explained that their recommendations for purchase to the Department of Health are based on having to look at things such as: “If we find that the clinical benefit is relatively small, if the side effects outweigh the benefits, if we are uncertain about the quality of the evidence, we are unsure about whether we’ve got the resources available, whether there are cost-effectiveness issues.

“Medication registration is about safety and efficacy and it doesn’t necessarily mean the state will regard it as a sensible purchase because they are taking into account all these other criteria which are quantifying the actual size of the benefit, equity issues, implementability, cost-effectiveness and affordability, but also as the Essential Medicines group we don’t want a whole bunch of products that are the same when we could deal with just one.”

The Sahpra chairperson, Professor Helen Rees, told the webinar, “The World Health Organization has a group that looks at things from a regulatory perspective and then they have other groups that look at the data from a more policy perspective.”

She said the regulatory group looks at therapeutics and vaccines from the context of an emergency such as the Covid-19 pandemic.

Rees explained that the WHO also runs a parallel process with a committee looking at the policy side of therapeutics and another committee called Sage that looks at vaccines from a policy angle. 

“Safety of vaccines is something that comes up very frequently and one other group that we work very closely with again from WHO is what’s called GACVS, which is the Global Advisory Committee on Vaccine Safety, and with other regulatory authorities globally to look at vaccines’ safety.”

Rees said it was very important for vaccine safety to work closely with the WHO and other regulatory bodies while new treatments are rolled out across the world. DM/MC

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