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Infectious Diseases

14 August 2020

SA regulatory authorities won’t license Russian vaccine without access to evidence - Prof Gray

Professor Glenda Gray says regulatory authorities in South Africa will not license a vaccine unless they have seen evidence that it works.

  • Russia recently became the first country to approve a Covid-19 vaccine
  • Scientists worldwide are concerned over whether the vaccine is safe and effective
  • Local expert, Prof Glenda Gray, said SA will only license a vaccine based on evidence

Russia's Covid-19 vaccine, named Sputnik V, became the first vaccine to be globally approved by a healthcare regulator, President Vladimir Putin announced on Tuesday. 

While Putin explained that the vaccine “works effectively enough, forms a stable immunity and… has gone through all necessary tests,” there is a lack of transparency as no data has been made available, and the researchers have not yet completed phase 3 trials.

Scientists worldwide are therefore concerned that the country has jumped the gun and are sceptical about the efficacy of the vaccine.

On whether the vaccine might make its way to South Africa and be used on the population, Professor Glenda Gray, President and CEO of the South African Medical Research Council (SAMRC), and member of the Ministerial Advisory Committee (MAC), said that regulatory authorities in South Africa will not license a vaccine unless they have seen evidence that it works.

Gray was one of the panellists on the 2020 Thought-Leader Webinar Series on Health and Modelling during Covid-19, hosted by the University of the Free State on Thursday.

What are the chances of Sputnik V being registered in SA?

“You need preclinical data and data in non-human primate challenge models to see that there is proof of concept, and then you need safety data in humans to see what the right dose [for a vaccine] is,” said Gray.

More than this, scientists also need to assess the immune response of vaccine participants. Once that is complete, the study requires large-scale clinical development to investigate the efficacy of the vaccine candidate. Gray explained that any regulatory body would want to see this kind of data before licensing and rolling it out to a population.

Gray added that South Africa is “safe”, as drugs or vaccines cannot be registered in our country without our regulatory authorities inspecting the data, safety and efficacy of the vaccine, as well as inspecting the manufacturing procedures.

“Vaccines have to be manufactured in a safe way and so SAPHRA (The South African Healthcare Products Regulatory Authority) will investigate the vaccine developers, making sure there is consistency from lot to lot.

“Normally, scientists publish their data first and show the world how and why it worked, so we need to see the biological evidence that his vaccine works before we can endorse it.

“Luckily for us, most regulatory authorities would not license a vaccine without having access to all the data, whether it’s the FDA (Food and Drug Administration) or SAPHRA… So unless they can produce the evidence, it’s unlikely to happen,” Gray said.

Update on SA vaccine trials

Speaking on the SA vaccine trials, Gray commented that in the global race to find a Covid-19 vaccine, there’s been a lot of cooperation between countries and governments, as well as funders.

The SA Ox1Cov-19 Vaccine VIDA-Trial, which kicked off in June, and is a collaboration between the University of Witwatersrand (Wits) and the University of Oxford and the Oxford Jenner Institute, has opened up 12 sites across the country and will probably be one of the earlier trials to show results, Gray said.

South Africa is set to partake in two new international trials of vaccine candidates in one to two weeks, Gray added. Gray confirmed to Spotlight this week that a Johnson & Johnson product called Ad26.COV2-S and a Novavax product called NVX-CoV2373 will be trialled in the country.

“So there are different strategies for vaccines, and the more vaccines that work, the better. We don’t want just one vaccine to work – we want many vaccines to work, and from different strategies because they have varying levels of efficacy.

“And the more vaccines that work, the more affordable they will be and the more doses we’ll have for the country,” Gray commented during the webinar.

SA needs to be contenders for vaccine development

Touching on why SA hasn’t developed its own vaccine, Gray explained it “takes millions of dollars” to develop vaccines, and that we need to invest in basic, fundamental science instead, so that we can also be contenders for vaccine developments.

“I do think we are fortunate to be in a wonderful space in South Africa,” said Gray. “We have an amazing opportunity to engage in vaccine development, and if we want to avoid a second wave, we’re going to have to invest in biomedical interventions like vaccines because those are the only ways that we can manage the epidemic.”

Let’s not forget about NPIs

While the country is moving to an epidemic phase of the pandemic, we still need to ensure that we minimise community transmission. And this is best done via continuing to implement non-pharmaceutical interventions, such as physical distancing, wearing face masks, and avoiding crowds, said Gray. Our testing strategy will also need particular attention.

“In trying to contain the epidemic, we’ll have to look at our testing strategy. We need to move back into community testing, tracking and tracing, hotspot evaluation and try to put out the fires in a way to prevent a second wave. So the work is not done yet; we have to continue to manage this.”

Gray also referred to the “five million team” – a term given by New Zealand’s prime minister, Jacinda Ardern to the Kiwis who pulled together behind her to fight the epidemic. The country showed early success in controlling the crisis.

“The beautiful thing about their approach, about calling themselves the ‘five million team’,  means that New Zealand understands the interplay between the citizens of the country, the government and the health sector,” said Gray.

South Africa needs to introduce a similar engagement and ensure that there is communication at all levels, and that citizens understand they have an important part to play in containing the epidemic moving forward.

“We all have a role to play in preventing transmission. We all have to buy into behaviour change and maintain it,” said Gray.

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READ | Vaccine developments: Update on the SA trial, and more reaction to positive news from Oxford