The complex world of Covid-19 vaccine trials explained.
SOMEWHERE IN THE DEEP UNEXPLORED depths of Madagascar, an unknown herb is probably on its way to becoming a global panacea for the pandemic.
This is Africa, a continent ripe with possibilities, where you cannot rule out that a cure for Covid-19 could perhaps come from nature itself. Just like Madagascar, currently touting Artemisia Afra (umhlonyane in Nguni languages and previously used as an ingredient for treating malaria) as a potential cure for Covid-19, bigger economies like South Africa are also looking to the botanical world for answers. Its national Department of Basic Education has reassigned R15 million ($960,982) of its budget on Covid-19 interventions such as Artemisia. Nigeria has also made a move towards a more homeopathic approach, as a ministerial committee has been put in place to further examine the potential natural compounds hold in combating the Covid-19 pandemic.
But the focus of this story is exploring humanity’s race to uncover a universal vaccine – or any cure – that can assuage a health crisis confronting the entire world.
Currently, there are over 60 possible vaccines the world over being put through the paces. Of these, only nine are in the third phase of trials. The road to finding a Covid-19 vaccine since the start of the pandemic this year has been long and arduous. For the layperson, desperate to see an effective vaccine come online soon, the deluge of news on vaccine trials can seem complex. This article will discern the facts around them.
In comparison to its European and American counterparts, Africa has seen a relatively lower rate of virus spread and a lower death rate. As of November 11, Africa accounted for 3.7% of the world’s total number of cases; and southern Africa the worst hit with over 800,000 cases.
Scientists are yet to definitively map out the effects of the Covid-19 virus and its ability to recur within individuals who have had it before. Fear of public spaces and physical interactions have become the norm. Face masks and sanitizing products have become staples in every handbag and car cubbyhole.
Put simply, a clinical trial is a series of phases within an experiment being conducted to test a new drug, type of therapy or new medical device. It also looks at the efficacy of pre-existing medical interventions in the treatment of numerous illnesses and different types of patients.
Clinical trials can be performed on both healthy and ill participants. There are a number of protocols and regulations that accompany a clinical trial to ensure that the wellbeing of the participant is maintained as far as possible. It ensures that the benefits of the medical intervention being tested outweigh the risks and each phase of a trial plays a part in testing this.
Clinical trials usually happen in four phases. Before these phases occur, a preclinical test is done. Each phase needs to produce a favorable result in order for the next phase to be conducted. In order for a medical intervention to get to the stage of manufacturing and distribution, all four phases need to have occurred successfully. The success of each phase is measured by the number of medically adverse events that have occurred as a result of the medical intervention being tested. These adverse events include mild to serious medical side-effects that have occurred to the participants of the trial.
Dr. Sinead Delany-Moretlwe, Director of Research at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa explains how innovations made with expediting the clinical trials for the Covid-19 vaccine could reshape how clinical trials are done across the board. She has also been the lead on HPTN 084, an injectable form of an antiretroviral (ARV) used to prevent HIV in women in sub-Saharan Africa.
The frantic search for a Covid-19 vaccine is being closely watched by every country on earth. At the time of going to press mid-November, there were currently 51 trials between Phases I and III of the clinical trials. When they will be available to all is a question on everyone’s mind.
South Africa’s Health Minister, talking to FORBES AFRICA about vaccine manufacturers, says: “Collaboration across global institutions has led to the transfer of technology and therefore new developments and new discoveries in combating the pandemic.”
In an interview with Aspen Pharmacare CEO and founder, Stephen Saad, he highlights to FORBES AFRICA the need for efficient manufacturing and distribution channels for the vaccine, once it becomes available. Aspen recently partnered with Johnson & Johnson for their vaccine Ad26.COV2-S(now known as JNJ-78436735). This partnership will see the manufacturing and distribution capacity of Johnson & Johnson increase significantly.
Saad explains that Aspen uses just 40% of their current manufacturing capacity for their own products and the other 60% was available for use. “Covid-19 is prevalent everywhere. We were very committed to trying to find a partner that would use our capabilities to be able to provide a vaccine,” says Saad.
At the heart of the partnership is the transfer of technology as Johnson & Johnson share their protocols and blueprint for creating the vaccine so they are able to manufacture it once it has passed Phase III trials.
“We are very pleased because Johnson & Johnson have made big commitments to distribute their vaccine universally, so they’ve made commitments through the Bill & Melinda Gates Foundation and to their own public statements about offering up 500 million doses to the developing world,” says Saad.
The manufacturing site in Port Elizabeth in South Africa’s Eastern Cape province will be utilized in this partnership where as many as 300 million doses can be produced and this is expected to begin the second quarter of next year should the Ad26.COV2-S proves successful.
“So much depends on the trials and the success of these trials,” says Saad. Aspen, having been linked to the success of the steroid Dexamethasone, and now as a vaccine frontrunner, have proven their reputation as a pharmaceutical powerhouse.
With an investment of R3 billion ($194 million) into their “sterile site”, Saad is confident. “There’s not a lot of companies that can manufacture on this scale,” he says.
Saad recognizes the urgency for a vaccine. “Our first and only priority right now is to get the product out to the world and our focus is on the job that we have to do very quickly over the next period.”
Currently, the only African country involved in the trial phases of these vaccines has been South Africa across different sites. Progress is being made by Oxford University as they await final clearance to begin trials in Kenya and the Uganda Virus Research Institute is aiming to collaborate with the Imperial College London and begin trials in Uganda in December.
Historically, only 2% of all vaccine trials have occurred on the African continent, according to a report in The Lancet.
Despite being no stranger to viral outbreaks, Africa as a whole is often excluded from the vaccine process and as such there is a severe lack of understanding of the African context when trialing a potential vaccine or medical intervention.
There are several factors that could possibly hinder the efficient and comprehensive administration of a Covid-19 vaccine when it eventually becomes available.
Accessibility to the vaccine is seen as a key issue, particularly within developing countries. While there are several initiatives such as the investments made by Coalition for Epidemic Preparedness Innovations as well as the Bill & Melinda Gates Foundation, African countries are still amongst the last buyers of any possible vaccine that emerges.
There is surely light at the end of the tunnel but it may be a while before a cure will finally see the light of day.