- Sahpra's vaccine approval process takes several aspects of safety, quality, and efficacy into account, says its CEO
- Although the process during the Covid pandemic has been expedited, these inspections won't be compromised, she added
- The regulatory body also continues to monitor a drug or vaccine post-approval
The South African Health Products Regulatory Authority (Sahpra) has dedicated a significant amount of their team members and resources to tackle the process of vaccine approval, Dr Boitumelo Semete-Makokotlela, CEO of the regulatory body said during a media briefing on Thursday.
“When it comes to vaccine regulation, we’ve expedited the process and we’ve included various mechanisms to ensure that as information becomes available, the applicant can make the submissions to us and provide us with data,” she said. There are currently two mechanisms that are part of Sahpra’s vaccine review.
The first one entails the information being made available to Sahpra, which is then reviewed. The regulatory body constantly engages with the applicant throughout this process, said Semete-Makokotlela.
“The second one is what we call a rolling review wherein the applicant makes a submission and as their data becomes available, they submit this to Saphra.
"This is to ensure we don’t have to wait for the full package of information to be made available for us to commence an evaluation process,” she explained.
Sahpra’s review process takes into account safety, quality, and efficacy, and includes questions around whether the vaccine has been manufactured in a mechanism that complies with good manufacturing practices.
The regulatory body also works with other regulators who conduct inspections at the site. If the site is based in South Africa, Sahpra conducts the inspection, Semete-Makokotlela said.
“We look at the safety of the product. This is where we look at pre-clinical as well as clinical data that has been collected from phase 1, 2, and 3 clinical studies,” she added.
In this case, Sahpra assesses whether the vaccine led to any adverse effects and if these adverse effects were associated with the vaccine itself, or if these are expected effects that can be managed.
The third element of their process involves efficacy and whether the vaccine does what it claims to do.
Safety: an ongoing collaboration
Professor Marc Blockman, Chair of the Pharmacovigilance Committee at Sahpra, explained that the safety aspect is an ongoing collaboration.
“There’s also been training of healthcare workers across the board to be able to recognise adverse events and report them to Sahpra in a timeous fashion so that one can look critically at these adverse events and decide whether it changes the benefit-risk ratio of the vaccine,” he said.
Sahpra recently launched the MedSafety app, which allows users to report adverse effects to hundreds of medicines and therapies, including the Covid-19 vaccines. The app, Blockman said, allows ease of access and availability of information to Sahpra. Semete-Makokotlela added that they’ve already received reports via the app.
Continuation of monitoring
“Our work doesn’t stop once the product has been registered,” reassured Semete-Makokotlela. “We follow a product throughout its life cycle. When it comes to these vaccines, we continuously monitor them. In our context, we’re looking at efficacy data as they’re being rolled out against the beta variant and any other prevalent variants of concern.”
The beta variant, also known as 501Y.V2, has been the predominant variant in South Africa since the second wave of infections.
Speedy process, but safe
When clinical trials are carried out, there aren’t very large numbers of people involved, said Blockman, which means rare adverse events are not always found in the clinical trial population.
“That does not mean to say it’s not safe. If we take a step back, one doesn’t go into a population until you really understand what this vaccine may or may not do,” he said.
“There will be animal data which one would look to see if there are signals of harm. One would also have biological data to understand its efficacy.
"And then there are different phases of vaccine development, despite it being accelerated, that will [include] different populations and give us an understanding of its safety."
Blockman stressed that the process is not done in isolation.
SA to produce mRNA vaccines
It was recently announced that South Africa fulfilled a number of criteria for it to become the first country in the world to host a new Covid-19 vaccine technology transfer hub, News24 reported.
The hub will allow SA to produce mRNA vaccine technology, which is currently used by manufacturers Pfizer-BioNTech and Moderna in their Covid vaccines.
One of the reasons South Africa was awarded the status to be able to develop this manufacturing practice was because of its regulatory authority, said Professor Helen Rees, Chairperson of the Sahpra Board. “You cannot put a manufacturing site for international vaccines into a country that doesn’t have strong regulation.”
Aspen's Gqeberha plant is currently manufacturing the Janssen Covid-19 vaccine by Johnson & Johnson.
Breakthrough infections are being seen both locally and internationally, where some people inoculated with the Covid-19 vaccine have still become infected with the disease, which poses the question of why countries are still continuing to immunise their populations.
Rees commented: “We are monitoring these breakthrough infections. We’re trying to identify which virus [variant] has caused the breakthrough infection.
"What we can say at the moment is although we are seeing breakthrough infections, it would appear, if we look at the [early] J&J data, which hasn’t been published yet, many of the breakthrough infections are mild to moderate disease.”
Experts are seeing a reduction in severe disease, Rees added, which is promising as less severe cases keeps people out of hospital and reduces the burden on the healthcare system.
Vaccine efficacy for both the Pfizer and J&J vaccines being rolled out in the country is very good, said Blockman. “It’s been shown [to have] 100% efficacy against severe disease and hospitalisation. So we are comfortable at the moment that the two vaccines are highly effective against serious disease from Covid-19.”
However, he added, “we must continue to accumulate data to make sure that data continues to be consistent with our approval. And we are committed to doing that.”
Sinopharm application received
Sahpra also announced this week that it had received an application for the Sinopharm vaccine which is being developed by the Beijing Institute of Biological Products Safety.
“The safety of the public takes precedence. If the regulatory requirements are not met, we will not issue authorisation,” said Semete-Makokotlela.
“We want to ensure that when you do receive a vaccine, you have confidence that it is a vaccine that is safe; is produced using quality mechanisms; and that it will be effective.”