Africa is in a very difficult corner. A third wave of the coronavirus, which is likely to be caused by the Delta and Delta Plus variants, is pulsing its way across the region, putting pressure on stressed and ailing health-care systems. Worse is that we simply do not know the scale of the challenge. SA is among few African countries that measure deaths attributable to Covid-19 causes. 

The consequences of an unvaccinated population are being felt across the continent, with many countries experiencing oxygen supply shortages, hospital beds at capacity, and mortuaries full. The world now needs to give Africa the attention it gave India some months back, lest the waves continue, more people die, and the virus keep mutating.

There is a welcome focus on investing in Africas capacity to make its own RNA-based vaccines, but such initiatives will take years to come on stream. The immediate pressure is to radically increase supplies of already developed vaccines to the continent and, once they arrive, to get them into peoples arms. 

There is no question that our efforts must focus on increasing supply. Set up with the aim of using pooled money to expedite Covid-19 vaccine research & development and to lower costs, the global Covax alliance is undergoing a major shake-up to improve its lacklustre performance. But we should work equally hard on ensuring  every vaccine is safe and taken up for use. It is now known that most individuals who hesitate to take vaccines are waiting on others close to them to take them first — the “wait and see” phenomenon.

It is also known that the longer it takes for vaccines to arrive, the more sceptical and suspicious people become. We make the case below that it is possible to counteract such understandable human tendencies by investing in the collection of vastly better safety surveillance data and communicating the results in real-time, so as to build public trust and confidence in what are among the greatest achievements of modern biology, technology, medicine and public health.

Postlicence vaccine safety surveillance, also known as postmarket pharmacovigilance (PMP), is the process by which approved drugs are monitored for adverse events and side effects. These include any unintended and harmful reactions that occur after administration of a medication such as a vaccine. They may be mild, such as pain in the injected arm following vaccination, or serious, such as a blood clot or myocarditis. PMP is of great value for two main reasons: the increased quantity and diversity of people getting vaccinated can show side effects that were not visible in preapproval clinical trials; and the more data available that shows vaccine safety, the more persuasive public health vaccination campaigns can be in boosting vaccine uptake.

There are two main forms of postlicence vaccine surveillance: passive and active. Passive systems collect unsolicited information such as voluntary reporting by health-care providers and the public. Active systems proactively request, collect and analyse data, usually in the form of clinical trials or large, interconnected health-care data systems. Though passive systems do serve a purpose by allowing committees to investigate potential adverse reactions if they are reported, active surveillance is the gold standard as it enables real-time, large-scale data collection and analysis.

The SA Health Products Regulatory Authority (Sahpra) and the department of healths expanded programme on immunisation co-ordinates PMP for vaccines in SA. In guidance released in January 2020, Sahpra stipulated that companies with approved medications must have full-time PMP employees and a system by which health-care workers can report adverse events. They must share their serious adverse event reports with Sahpra and the National Adverse Drug Event Monitoring Centre within 15 days of receiving them. Nonserious adverse events are shared in infrequent periodic safety update reports.

This year SA began offering the Med Safety app, an electronic alternative to the archaic paper-based adverse event reporting that has been occurring to date. Though the app is available to the public, only health-care workers are permitted to report adverse events after immunisations, according to a Sahpra representative quoted in April. Through the expanded programme on immunisation, SA shares its vaccine safety data with Vigibase, the World Health Organization’s  (WHO) worldwide platform. SA is also a part of the recently developed AU smart safety surveillance (AU-3S) programme, a Bill & Melinda Gates Foundation-funded project focused on increasing health safety surveillance capacity, which is piloting in four African countries.

SA is taking small, yet significant, steps towards bettering pharmacovigilance. Future improvement requires significant additional resources to be invested in the medical capability to investigate the causes of adverse effects and to support appropriate clinical interventions. In the US, for example, there are large medical teams associated with seven resource-intensive university medical centres working feverishly to do deep-dive research into the causes of adverse events that can take weeks if not months to resolve, if they are resolved at all.

Though SA is making crucial progress, most African countries are lagging behind. A 2019 study found that just 27 African countries  about 50% of the continent reported 10 or more adverse events to the WHO through expanded programmes on immunisation. This suggests half of African countries do not possess minimum country capacity for vaccine monitoring. A 2018 study revealed that a mere five African countries have enacted PMP measures as recommended by the Global Vaccine Safety Initiative.

The current PMP systems, both in SA and in other African countries, are insufficient. The latest data shows 64% of South Africans are vaccine-willing, well below the percentage needed to obtain herd immunity. Importantly, of those hesitant to get vaccinated 25% report that they do not yet know enough about the vaccine to make a decision.

These themes run true throughout Africa; in Ethiopia, 28% of those who do not want to be vaccinated cite a lack of knowledge on the vaccine as a reason. In Nigeria, that number is 26%. It is clear that investing in African PMP improvement will allow for more effective public health campaigns, increasing vaccine confidence and uptake.

The Vaccine Safety and Confidence-Building Working Group, based at Columbia Universitys Centre for Pandemic Research, is beginning a pilot in SA, with the intention of expanding to other African countries. This working group was set up to catalyse safety surveillance projects that generate, scale and analyse actively collected vaccine safety surveillance and pharmacovigilance data.

The aim of the project is to monitor side effects and adverse events so as to alert public health clinicians to intervene when necessary and to increase confidence and public trust in vaccines through the rigorous collection and dissemination of this data. Not only are these capabilities a crucial priority if Covid-19 is to be managed on the continent, they will also be essential infrastructure for future pandemics and rapid vaccination campaigns.

The Group of Seven finance ministers are meeting from July 8-9 to consider investments in the prevention, response to and recovery from the Covid-19 and future pandemics. We would like to put a safety surveillance system on their radar screen and in so doing work to defeat this pandemic and those to come.

• Pyne is a research assistant and Dr James a senior research scholar at Columbia University


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