Research

Protecting Africa from becoming vaccine test lab

Wagdy Sawahel

The University Times

Despite the lack of clinical trial and public data on the safety and efficacy of Chinese COVID-19 vaccines, several African countries, including Egypt and Morocco, have been gearing up to use them.

This turns the spotlight on universities and their role in protecting African communities from becoming vaccine-testing laboratories.

Some questionable practices have already emerged in the scurry to obtain doses.

Egypt’s health ministry sent out an invitation to doctors to be vaccinated against COVID-19 using a Chinese vaccine without making clear it was a clinical trial, according to an article published on 30 December 2020.

This corresponded with earlier reports in which the Egyptian Initiative for Personal Rights raised concerns about several legal, ethical, scientific and health aspects pertaining to Egypt’s participation in Chinese COVID-19 vaccine trails.

“African universities must stand against the use of Chinese vaccines until they are proven to be safe and efficacious via independent peer review mechanisms,” Ifeanyi McWilliams Nsofor, the director of policy and advocacy for Nigeria Health Watch, told University World News.

Nsofor, who is also Senior New Voices fellow at the US-based Aspen Institute and senior Atlantic fellow for Health Equity at George Washington University, said universities had to be proactive and should insist that regulatory authorities on the African continent follow science before approving COVID-19 vaccines in Africa.

This is because, without a doubt, any adverse reactions that might occur following vaccination could lead to vaccine hesitancy and derail efforts to vaccinate Africans, he said.

COVID-19 vaccines

But according to initial indications, many Africans appear willing to be vaccinated.

Nearly 80% of adults in 15 African countries said they would take a COVID-19 vaccine if was safe and effective, according to a 17 December survey conducted by the Africa Centres for Disease Control and Prevention (Africa CDC), in partnership with the London School of Hygiene and Tropical Medicine.

But the survey does beg the question about which of the several available vaccines are, in fact, safe and effective.

As of 15 January, the World Health Organization (WHO) COVID-19 candidate vaccine landscape database, which compiles detailed information on vaccine development, included 64 COVID-19 vaccines in clinical development and 173 vaccines in pre-clinical development.

At least two countries in the Middle East, including the United Arab Emirates (UAE) and Bahrain, have authorised the COVID-19 Chinese vaccine developed by Sinopharm’s Beijing Institute of Biological Products for emergency use for healthcare workers and other priority individuals.

The UAE, Bahrain and Sinopharm reported the Chinese vaccine was found to be 86% effective in the UAE and Bahrain and 79% in China, but the countries have not yet released the data used to make these efficacy claims.

The Sinovac Chinese vaccine underwent clinical trials in Brazil, Indonesia and Turkey, which reported efficacy rates of respectively 50.4%, 65.3% and 91.25%.

Professor Hildegund Ertl from the Vaccine and Immunotherapy Center of the US-based Wistar Institute, told University World News that, although China had approved vaccines, she was not sure about their safety and efficacy.

Pfizer-BioNTechModerna and Oxford-AstraZeneca COVID-19 vaccines have been shown to be safe, with varying degrees of efficacy of respectively 95%, 94.5% and about 70%.

On 31 December 2020, the WHO reviewed the data on the Pfizer-BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis and found that the vaccine met the must-have criteria for safety and efficacy set out by the WHO, and that the benefits of using the vaccine to combat COVID-19 offset potential risks.

Quality control

“Regardless of the source of the vaccine, Africans must do quality control of all vaccines that are imported or developed locally,” said Professor Vincent Titanji, a fellow at the African Academy of Sciences, the Academy of Sciences for the Developing World and an honorary dean at the faculty of science, University of Buea, Cameroon.

He added: “This is feasible and it can be done through the African Union or the Africa CDC. Only vaccines that have gone through clinical trials in Africa should be accepted in Africa. The research team should include African researchers at all levels.

“As far as I am aware, there are labs in South Africa, Kenya, Morocco, Senegal, Cameroon, Nigeria and Ghana which have the capacity to do this type of quality control,” said Titanji.

Professor Zeblon Vilakazi, the vice-chancellor of the University of the Witwatersrand (Wits), South Africa, agrees with Titanji.

He is also adamant that the correct protocols in vaccine research should be followed and “in collaboration with local leading institutions [with leading local experts] as co-partners,” he told University World News

Nsofor from Nigeria Health Watch agreed that African universities should get involved in local clinical trials on the continent. This could be achieved through their medical schools, teaching hospitals and medical centres, he said

To protect Africa from being used as a testing lab for COVID-19 vaccines, the Wistar Institute’s Ertl said, African universities should ensure the use of a vaccine that had been shown to be safe and effective in Phase III trials, including volunteers with a genetic make-up that was relevant to the African population.

“Ideally, the vaccine should undergo testing in Africa in a Phase III trial, but that may not be practical considering the urgency to get humans protected against COVID-19,” Ertl said.

As of 19 January 2021, out of 4,483 COVID-19 studies worldwide searching for drugs or vaccines, only 233 or 5% for COVID-19 were carried out in 26 African countries, including 158 studies in Egypt, 31 in South Africa, 11 studies in Tunisia and seven in Nigeria, according to the online platform of the US-based National Institutes of Health, which lists all registered, ongoing clinical trials globally.

Yet, there are a growing number of efforts to increase the visibility of African clinical trial sites and the investigators with the potential to participate in COVID-19 clinical trials.

The African Academy of Sciences launched the Clinical Trial Community online platform to promote and enhance intra-Africa collaboration around clinical trials with the aim of reducing duplication of work across the region as well as accelerating the fight against COVID-19.

One of the scientists involved in the trials as part of a quality control process is Professor Shabir Madhi, the executive director of the Vaccines and Infectious Diseases Analytics Research Unit at the University of the Witwatersrand, which has played a leading role in the Oxford COVID-19 vaccine trials in South Africa.

“This is pretty much the bottom line. There are no shortcuts to getting vaccines licensed, even if for emergency use,” he told University World News.

Madhi is a co-author of the 2020 study entitled “Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: An interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK”, which is an example illustrating the Oxford COVID-19 vaccine trial carried out at Wits.

The study showed that the Oxford-AstraZeneca vaccine candidate had an acceptable safety profile and was effective against symptomatic COVID-19.

Quality control, including trials, will help to counter the suspicions of many Africans that they are simply the ‘lab rats’.

This is necessary, said Nsofor, to ensure that people get the vaccine timeously.

In addition, African universities are central to ensuring acceptance of vaccines in the continent as they are well-placed to lobby national governments and their immediate communities.

Local manufacturing

But African universities are not only involved in quality control. Some experts believe they should join forces with the pharmaceutical industry and funding organisations to manufacture COVID-19 vaccines in the continent.

This has become pertinent as some of the vaccines demand special arrangements in terms of transport and storage.

“For instance,” said Nsofor, “Africa needs about 1.7 billion doses of the vaccine, assuming two doses per person, to vaccinate about 70% of its citizens (about 875 million persons) to achieve herd immunity. This means that, to fill this gap, Africa must produce the vaccine locally.

An October 2020 study entitled “Vaccine efficacy needed for a COVID-19 coronavirus vaccine to prevent or stop an epidemic as the sole intervention” concluded that a vaccine “has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures such as social distancing”.

Furthermore, up to 75% of the population has to be vaccinated. An efficacy percentage below these figures would require a potentially unachievable 100% coverage of the population.

In an initiative to support the vaccination effort, Afreximbank is providing a vaccine-financing framework for Africa.

Through this initiative, countries will issue promissory notes to Afreximbank, which will arrange about US$4 billion in revolving credit to back orders from African suppliers that have been certified by the Africa CDC in Addis Ababa.

“African universities should get involved,” said Nsofor.

COVID-19 vaccine development

But not everyone agrees with the idea that Africa should manufacture its own vaccine.

Ertl said it would take too long to make an ‘own vaccine’ on the continent. “But if you can identify a pharma company that is able to fill or finish a vaccine, that could be helpful to speed up vaccination,” she said.

Titanji from the African Academy of Sciences said there was another way. Whereas African universities and researchers should develop manufacturing capabilities, it might be more practical [at this point] to tap into existing initiatives aimed at providing Africa with a vaccine.

“It is urgent to develop the capacity to develop drugs and vaccines on African soil. This is feasible if we work together with bilateral and multilateral partners under the auspices of the African Union.

“But we need not invent the wheel, as it is easier for Africa to negotiate lower-priced vaccines developed in the Global North through the WHO’s COVID-19 Global Vaccine Access Facility – known as the COVAX facility – and bilateral agreements than to create our own vaccines for COVID-19 from scratch. The two approaches are not mutually exclusive,” Titanji said.

COVAX aims to pool resources and share vaccine development risk to ensure equitable access to vaccines when they become available through providing doses for at least 20% of countries’ populations.

A provisional 270 million doses of COVID-19 vaccines have been secured by the AU for distribution across the continent from three major suppliers: Pfizer, AstraZeneca (through Serum Institute of India) and Johnson & Johnson, along with 600 million doses already promised from COVAX, according to a 14 January press release.

Global common good

An appeal to declare the COVID-19 vaccine as a Global Common Good was issued calling for making it free from intellectual property so that it belongs to anyone, and the research results should be in the public domain, making it available to any production facility that pledges to operate under strict international regulatory supervision and only to such facilities.

“We urge the WHO to design a World Action Plan on COVID-19 vaccine … set up an international committee responsible for monitoring the vaccine research and to assure equal access to the vaccine for all countries and all people within a publicly announced predetermined time frame,” stated the call.

“The only way to definitively eradicate the pandemic is to have a vaccine that can be administered to all the inhabitants of the planet, urban or rural, men or women, living in rich or poor countries,” it continued.

Preparing for the next pandemic

The crux remains that African universities have a critical role to play during crisis times such as the current pandemic.

They should lead the way in voicing concerns over vaccine ethics and about quality control and should participate in generating the scientific knowledge needed to steer humanity through this rough patch.

Several institutions, like Wits, have been doing that, but Magdi Tawfik Abdelhamid, professor of biotechnology at Egypt’s National Research Centre in Cairo, told University World News that other universities also had an opportunity to get involved in the largest clinical trial of potential COVID-19 treatments on the African continent.

It was launched recently to test drugs with proven efficacy on participants with early- or moderate-stage infection to stop disease progression with the aim of preventing spikes in hospitalisation as well as protecting fragile and overburdened health systems in Africa.

“African universities must follow the example of South Africa-based Wits University in participating in clinical trails and test Western vaccines locally to be relevant for the genetic diversity of people in African countries and to act as a safeguard of any possible health risk and-or any bad side effect on the long term,” Abdelhamid added.

He said that, although there was no clear-cut evidence that the multiple COVID-19 variants circulating globally, and which have been detected in South Africa, the UK and Brazil, and the possible emerging of other new variants of the coronavirus are able to render all the vaccines useless.

“Mass vaccinations could drive the evolution of the virus, and we may have to regularly update the vaccines, as we do for flu, to keep up,” he emphasised.

As the battle against COVID-19 continues, scientists have warned that this will not be the last pandemic to sweep across continents.

An 8 October 2020 study indicated that Sub-Saharan Africa is one of the regions that have the largest number of cities at the greatest risk of having the next pandemic.

The University Times

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