Africans must be involved in vaccine trials, and prepare now for day one of the vaccine availability
In an ideal world, communities should not be mere spectators but co-architects of health decisions impacting their well-being. Concerns around vaccine trials should be addressed and researchers should prioritize community engagement.
What then does a vaccine trial mean to communities? Why should they care? Specifically, what must African governments do?
As we anxiously wait for the COVID-19 pandemic to be controlled, let's start with understanding herd immunity and why vaccines are critical. Simply put, herd immunity is when a large number of people in the community is infected and therefore immune to a disease, in this case COVID-19.
Per estimates, herd immunity for COVID-19 will be achieved when more than 60% of the population is infected. That is 780 million Africans! As of 23 August 2020, about five months since the first case was reported on the continent, Africa has 1.18 million cases, 27,610 deaths and 900,584 recoveries. We are a long way to herd immunity! It is therefore an unrealistic plan to achieve herd immunity naturally.
However, we can simulate immunity in people through vaccination and accelerate reaching herd immunity. The need for an effective and safe vaccine is therefore urgent. This why the COVID-19 vaccine remains our only hope to controlling the pandemic.
According to the World Health Organization (WHO), as of 25 August there are more than 170 COVID-19 vaccines under trial. About 138 of them are at the pre-clinical stage (not yet in human trials), while 27 of them are in phase one (small-scale safety trial), 17 are in phase two (expanded safety trials), 7 in phase three (large-scale efficacy trials) and none has been formally approved for general use.
Normally, vaccines require many years of design, testing and additional time to produce at scale. However, researchers are racing to develop a COVID-19 vaccine within 12 to 18 months. South Africa is currently the only African country participating in vaccine trials.
Vaccine development begins with basic laboratory studies on the virus and its interaction with body cells. The results inform pre-clinical studies in which the vaccine is tested on animals and its safety recorded. Reaction of the animal's body cells are documented and inform the four phases of clinical trials in humans.
The four phases of vaccine clinical trials
In phase one of the trials, the safety of the vaccine and its ability to stimulate the human body to produce immunity is determined. Dosage, the best way to administer the vaccine and the right potency are also determined.
Phase two of the vaccine trials involves a larger population, determining outcomes, including the ability for one's body to develop immunity against COVID-19 as well as the side effects of the vaccine.
Phase three of the trials reaffirms efficacy and longer-term safety of the vaccine and involves administering it in larger populations, and observing them over a longer period of time. Once a vaccine passes phase three trials, it is licensed for commercial production and public use.
The last phase, phase four, trials involve on-going surveillance as the vaccine is administered to communities.
Trials can be stopped at any phase, restarted, modified, etc. depending on what is observed. In order to effectively study a human body's reaction to vaccines, all corners of the world must be part of the trials. Vaccines have to be tested in different settings and in people with different genetic makeup. Therefore, Africans cannot afford to not participate in vaccine trials.
How Africa can prepare for COVID-19 vaccine
Not only must Africans be involved in vaccine trials, African countries must prepare now for day one of the vaccine availability. Preparation ensures that vaccines leave the manufacturer's site, land at an airport in Lagos, Addis Ababa, or Ndjamena etc., and eventually get to a health centre in Maridi, Kumbo and Khayelitsha.
Preparation for the COVID-19 vaccine requires countries to: (i) determine the eligibility criteria - who will be prioritized and why; remembering that most vaccine schedules currently target children; (ii) develop a robust vaccine distribution strategy; (iii) identify where the vaccine will be administered and by whom (doctors, nurses, etc.); (iv) develop a robust procurement, supply chain and distribution plan; and finally (v) have a sustainability plan to ensure continued availability and access to the COVID-19 vaccine.
Therefore, African governments must:
Consolidate and amplify the African voice - Vaccine nationalism is on the rise. Countries involved in developing vaccines are prioritizing their populations and will likely hoard vaccines. Unfortunately, with infectious diseases, no one is safe until we are all safe.
At the same time, Africa must continue its concerted efforts to jointly respond to the pandemic - including development, production and distribution of a COVID-19 vaccine. Within the framework of the Africa Union's Consortium for COVID-19 Vaccine Clinical Trial and the pooled medical procurement platform, member states should negotiate for favourable vaccine access agreements. Supporting financial and technical assistance to countries such as South Africa, Kenya and Senegal, among others, for local vaccine production would be a great win.
Streamline and institutionalize country readiness - Besides continental level efforts, necessary measures to prepare for the COVID-19 vaccine are critical. This includes establishing multi-sectoral structures to facilitate supply and distribution mechanisms, building capacity of health care workers to administer and monitor vaccine safety, documenting immunization outcomes, and mobilizing domestic and external resources to facilitate rapid vaccine supply and distribution.
Develop strategies to sensitize communities - Researchers around the world are accelerating vaccine development. The next obstacle, unless addressed now, is vaccine hesitancy, the fear of the unknown if one gets vaccinated. Communities must be at the centre of COVID-19 vaccine trials and efforts geared towards full utilization.
Communities should play a seminal role in identifying and reaching most-at-risk populations during immunization campaigns. This is the time to engage communities through community gatekeepers, including Community Health Workers, religious and cultural leaders, to allay vaccine fears.
Successful sensitization of communities will lead to positive participation in vaccine trials and uptake of the COVID-19 vaccines.
There has been significant advocacy focused on the funding, accessibility and availability of the vaccine. Unfortunately, Africa is largely playing a spectator role when it comes to COVID-19 vaccine trials. The ongoing 'scramble' for the yet-to-be approved vaccine has raised concerns that the most at-risk populations in low- and middle-income countries will be deprived of this life saving commodity.
African governments must continue to work in unison and strategically position our continent to ensure timely and equitable access to the vaccine once approval is granted. This calls for urgent continental and country level actions and, placing communities at the centre for optimal acceptance and utilization of this immunization against COVID-19.
*Amref Health Africa is a leading health NGO headquartered in Nairobi. Founded in 1957, Amref supports communities across 35 African countries to build resilient health systems.
Prof Joachim Osur is the Technical Director of Programmes at Amref Health Africa, as well as Associate Professor of Sexual and Reproductive Health and Dean of the School of Medical Sciences at Amref International University. He is a public health, reproductive health, and sexual medicine specialist with a wide experience in health programming in the African context.
Dr George Kimathi is an accomplished health development specialist with over 20 years' experience in design and implementation of integrated public health programmes. He is the Director of Amref Health Africa's Institute of Capacity Development (ICD), providing overall leadership to the organization's Human Resources for Health (HRH) agenda.
Lolem B. Ngong is a seasoned Global Public Health professional, with more than 15 years of leadership in global health diplomacy and coordination of strategic partnerships to address threats to public health. An epidemiologist by training, Ms. Ngong is the Chief of Staff at Amref Health Africa.