To ensure the timely supply of a COVID-19 vaccine, the Nigerian government recently signed a Memorandum of Understanding (MoU) with Russia. An earlier headline, which was later corrected, suggested that Nigeria had already received vaccine samples from Russia, sparking fear and disapproval from the Nigerian public, especially since the Russian vaccine candidate has not gone through all the required phases to be administered safely to the public. The fear was also due to a history of unethical vaccine testing in African countries.
This interview with Bunmi Ode shows how Nigeria and other African countries can prepare for safe and accessible distribution of COVID-19 vaccines. Bunmi Ode is a Nigerian paediatrician who specialises in caring for children in intensive care units (ICUs). Ode works with Alima, an international NGO, which provides medical care and health services to countries in Central and Western Africa. She is a public health expert, with a Masters in Public Health.
Is an expectation for a vaccine in late 2020 or early 2021 feasible?
Vaccine development takes a while because it goes through many processes to assure safety and efficacy. In some instances, scientists have fast-tracked vaccine development for diseases like H1N1 and Ebola which have important public health significance. The ability to fast-track a vaccine’s development is made easier when we already have pre-existing knowledge and models on the virus. For example, annual flu vaccines build off existing influenza vaccine knowledge, making it easier to tweak and fast track a new vaccine. This is especially true if the disease in question is from an already well-studied family of viruses, and we know that COVID-19 is from a well-researched family of coronaviruses.
There was a lot of pushback against the news that Nigeria accepted vaccines from Russia. Has Russia carried out the recommended procedures for vaccine development?
Let us assess the steps for a proper vaccine trial and compare that with what the Russian vaccine candidate has undergone. The proper development steps are as follows:
- The initial preclinical phases study the science of the virus to get scientific information about the virus’ microbiology and infectious behavior, as well as the vaccine candidate’s effects in animals
These initial steps can be fast-tracked for COVID-19, as we already understand coronaviruses in general, and we have experience developing vaccines against SARS CoV – an earlier coronavirus-related respiratory disease. The next step is carrying out human trials which usually happens in three phases.
- Phase 1 trials test for the absence of major risks within a small group of about 70-80 healthy adult volunteers. They also check that the vaccine stimulates an immune response in the volunteers
- Phase 2 trials are usually larger, involving several hundred volunteers. The goals of this stage are to screen for less frequent risks and establish the dosing and administration schedule of the vaccine
- In phase 3, tens of thousands of volunteers are tested against either a placebo group, or a group receiving vaccination for another disease. Participants are dosed blindly in a randomized and controlled manner to assess the effectiveness of the vaccine in protecting against the disease. A placebo is an inactive substance, sometimes called a sugar pill, to ensure that results are not skewed by a psychological effect. The goal of this phase is to assure that the vaccine not only stimulates the body’s production of antibodies but offers protection against the disease as well. This phase also checks for the occurrence of infrequent side effects
The Russian vaccine candidate was fast-tracked at the first two steps, lumping phase 1 and 2 together, within a span of 6 weeks. According to the Lancet article by the Russian scientists, the vaccine was tested in a small group of 76 adults, it showed no immediate major side effects, and it stimulated antibody production in the participants. The scientists also determined an administration schedule for the vaccine during this phase. What they are yet to show is that the vaccine is safe for use in large numbers of people and that the immune response stimulated by the virus (antibody production) leads to protection against the disease.
What are some strengths of Russia’s COVID-19 vaccine development?
The phase 1 and 2 results show that the vaccine is a potentially viable candidate. However, we need to be sure that the vaccine is fully and safely tested and developed. Normally, nobody would approve a vaccine that has been tested on only 76 people. Going from the data published in the Lancet alone, it would seem a viable vaccine candidate. What is unusual is the Russian government basing the vaccine approval simply on results from phase 1 and 2 trials alone. We still need to establish the vaccine’s safety and effectiveness in a randomized study of thousands of volunteers.
A study found that only 50% of Americans were keen on taking a vaccine, and about 26% of people in France will not take a vaccine. What are some fears communities have with vaccination, or new vaccines?
As a pediatrician, I love vaccines. I believe in them, I’ve seen the efficacy in children, I’ve administered them, and I’ve gotten them myself. Vaccines have improved the health of people around the world, they save lives and prevent severe illness. Smallpox is one well-known example of vaccine success, and there’s the recent eradication of polio in Nigeria due to vaccines. For some reason, vaccines still get a bad rap in some communities, ranging from fears that vaccines themselves cause widespread illness to beliefs that vaccines have the capacity to be used for political control.
While there is no evidence to back any of these fears, the research showing the life-saving benefits of vaccines is robust and clear. Due to the global impact of this pandemic and its devastating effects on many facets of general life, many people feel a sense of helplessness and confusion. A lot of the narratives circulating out there are an attempt to make sense of the situation, to instill a sense of order and understanding where there is none.
With this existing background of mistrust and suspicion about the virus, scientists and public health experts like myself are aware of the risks involved with approving vaccines which skip the regular processes and procedures. Therefore, while following the proper vaccine development procedure is important in general, it is even more essential in this situation. Vaccines that skip important processes may worsen vaccine hesitancy in the population. Further, if a vaccine is improperly tested and is eventually found to be unsafe, it could harm vaccine trust in the population, and if it is found to be ineffective, it could worsen disease transmission. Finally, not following proper vaccine procedure could worsen the existing narratives about the unethical testing of medical products on African populations.
What can countries do to prevent vaccine fears and hesitancy?
It’s like introducing a new innovative product, there will always be innovators and early adopters. When people see that the early adopters are safe and nothing catastrophic is happening to them, others will join in too. To ease the public’s fears, governments will need proactive public health campaigns, with careful pre-messaging, to ensure proper information dissemination around vaccination, like was done for the polio campaign in Nigeria. Additionally, the vaccine acquisition process is important. If the public believes that the vaccine acquisition process is not transparent, and has not been properly vetted, there’s an organic suspicion and fear that develops, as people may believe that they are being used as test subjects – a difficult scenario to manage.
How can countries ensure that they have access to COVID-19 vaccines once they are ready?
Of the current about 150 potential vaccine candidates, any vaccine which becomes successful will have to supply billions of doses for global normalcy to return. Experts expect high-income countries with strong research bases to have quick access to approved vaccines. Some high-income countries have already signed MoUs with several manufacturers for millions of doses. However, poor countries may not have quick access to the vaccine until wealthy countries have secured their population – prolonging infections and suffering in low-income countries.
Nigeria has taken a proactive step by signing an MoU with Russia for supply once the vaccine is ready. An MoU is the right path for low-income countries to guarantee access to its population once vaccines are ready. The WHO is also putting bids to acquire large samples for low-income countries, through its COVAX programme, signed by several wealthy countries, except the US.
There have been concerns about the racial/ethnic disparity of vaccine efficacy/effects. South Africa is the only Sub-Saharan African country that has volunteered to participate in COVID-19 vaccine testing. Should more African countries be open to safe testing for an inclusive vaccine?
Absolutely, there should be more inclusive testing in vaccination and drug development in Africa; however, these trials must be done in a safe and ethical manner – the same as it is in Western countries. Early stages of vaccine testing involve volunteers. Volunteers should be recruited, as they are in countries such as the US, Germany, and France. Volunteers in African countries should be aware of risks and benefits, and motivated by individual goals and beliefs, rather than feeling coerced. So, yes, we absolutely need more contextual vaccine and drug development in African countries, while maintaining strict transparency, respect, and ethics throughout the trials.
The conversation with Ode suggests that there are many hurdles to cross to ensure a safe and accessible vaccination program in Nigeria. Proper vaccination programs will require a tri-sectoral partnership between the public, private, and social sectors, especially to support government efforts in vaccine acquisition. Countries will also require tri-sectoral efforts in the designing of careful public awareness campaigns, with high penetration in different socioeconomic settings that eradicate fears from false theories. Insights from this interview also suggest that although there is a strong push for a global access to a COVID-19 vaccine from the WHO, African leaders will need to take more proactive steps by coordinating efforts to sign MoUs with vaccine manufacturers to ensure timely access for their countries. Lastly, the need for a transparent and science-backed approach to vaccine acquisition cannot be overemphasized, especially if Nigeria and other countries want to carry out successful vaccination programs.
Samuel Kanu works with Dalberg, a global strategy consulting firm, working to build a more inclusive and sustainable world by supporting a wide range of organizations on initiatives that tackle society’s most pressing issues.