Malaria shot was approved in 2015 by the WHO for children’s vaccination but is now being rolled over in parts of Africa in 2024 leaving many an observer asking a basic question: WHY that delay of 9 years? It is now estimated at least 143, 000 African babies had died yearly because of the deferment. This article investigates the challenges in the development of the malaria vaccines, their efficacy and whether there is a light at the end of the tunnel.
After a decade has passed and almost a billion dollars spent, we are now in a position to welcome the arrival of a malaria jab specifically designated for African children. It is a cautionary tale of struggles, feats and future concerns all rolled into one. As the jab is being distributed to a handful of African countries of eight only, its impact will be very much limited but it is a point of start. Something is better than nothing at all.
The idea of malaria vaccines as most of them always originated from Africa except abroad but somehow the idea was adopted to benefit Africans. The US Army once researched the Malaria vaccine in the 1980s with the drug company GlaxoSmithKline – GSK, and together they produced promising prototypes.
The US Army was more interested in protecting its own soldiers deployed in the tropical countries. However, the US Army lost interest and withdrew itself leaving GlaxoSmithKline PLCÂ (GSK) with a problem to solve without the resources to do it. Sub-Saharan Africa was their main client who needed the jab most but had neither the resources nor the political will to pay for the millions of dollars for the vaccine.
GSK had to find a philanthropic institution that would foot the bill for the benefit of the poor in Africa. It found one in the nonprofit global health agency PATH, and by the late 1990s, they had a vaccine to test. The Bill & Melinda Gates Foundation put up more than $200 million to test it.
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The clinical trials were complex because this was a whole new type of vaccine — the first ever against a parasite — delivered to children in places with limited health systems. The process took more than a decade. Finally, in 2014, results showed this vaccine cut severe malaria cases by about a third.
This was a successful result, but not as much protection as scientists had hoped to see. Still, GSK and PATH planned a production facility to make millions of doses. Gavi, the organization that procures vaccines for low- and middle-income countries, with funds from donors, would buy them.
The lack of clarity on malaria targets left scientists slogging out to thrash out whether elimination of the malaria parasite or protecting the victims had more chance of success. Methods of modifying mosquito genetics were floated as more economical to remove its ability to infect humans with deadly bacteria.
Data-obsessed scientists were reluctant to give a malaria vaccine any chance because the history of such medical undertaking was full of uncertain risks unknown deterring many from recommending taking that path where resources may be seen recklessly misdirected to a lost cause, beneficiaries showered with false hopes, and upending competition posed by other life-threatening diseases such as tuberculosis.
GSK and PATH tried to push the vaccine forward. The company submitted a 250,000-page dossier to the European Medicines Agency, which can approve products not relevant in Europe but of humanitarian benefit. In 2015, the agency said the vaccine was safe (with some issues it wanted GSK to continue to study), and PATH began hunting for new financial partners to replace Gates.
The pressure to approve the clinical trials for the malaria vaccine grew because of the hundred thousand deaths of children in Africa yearly due to malaria. However, scientists were reluctant to approve it because, in initial trials, a small number of children developed meningitis. That reality turned out to be a stumbling block for the approval.
They argued that a small increase in cases of meningitis in children who got the shot hadn’t been sufficiently explained. If this small-chance issue turned out to be an actual problem, it could undermine African parents’ confidence in all childhood vaccines, with catastrophic consequences.
Second, they feared that countries might struggle to deliver the vaccine. It came in four doses, none delivered on the usual childhood immunization schedules; the last dose came a year after the third, and without it, the vaccine offered little protection. In the end, there was a compromise: The WHO announced what it called a pilot implementation, in Kenya, Malawi and Ghana, that would cost close to $100 million.
With instructions to have more clinical trials, GKS was turned off and repurposed her production plants once earmarked for malaria vaccines to cater to other medical products that were decided to have a higher commercial value. Two years later, the W.H.O. had scraped together funding. GSK restarted a small production line to make enough of the vaccine for the study. At Gavi, however, board members representing Africa were demanding answers.
Gavi teamed up with MedAccess, an organization that provides funding to reduce the financial risk for private companies working on medical products for low-income nations. With MedAccess’ support, Gavi offered a deal to protect GSK from financial risk, saying, in essence, we’ll fund you to start producing, and if the vaccine isn’t approved, we’ll cover the loss. GSK agreed and kept the production line open.
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In the end, the news was good. Data from the pilot showed no safety risk, and the WHO approved the vaccine for Gavi to buy in bulk and ship to Africa. It was December 2021. But then GSK told Gavi that after all the agony of winning approval, it could produce only 12 million doses of its vaccine each year, tens of millions fewer than anxious countries were hoping for.
Many people in the vaccine world believe that the issue was the chemical used to boost the strength of the immune response from vaccines, something called an adjuvant. It was made from the bark of a Chilean tree, and it has proved to be one of the most valuable substances the company ever produced.
When GSK said it would be limited in how much of its malaria vaccine it would make, angry collaborators at the WHO and other agencies suggested it was because the company was keeping most of the adjuvant for more lucrative products such as its shingles vaccine, Shingrix, which sells for $350 per dose (compared with $10 for the malaria shot).
GSK says that the adjuvant is not the constraint but that the factory that produces the vaccine is 50 years old and simply can’t make any more than those 12 million doses at present. The company says it will expand to an additional three million per year starting in 2026.
The company has licensed the vaccine to Bharat Biotech, a drug maker in India, and is sharing the technology to produce it, but that process is complex; it will be at least five years until Bharat is making the vaccine on its own.
In the meantime, GSK will upgrade its facility in Belgium later this year, and then make about 15 million doses a year until Bharat takes over. But until the end of 2025, there will be enough doses for only 4.5 million children, which could mean many more may fall ill and die.
The second malaria vaccine developed by Oxford University came around but faced similar financial hurdles until 2021, when the Serum Institute of India, the world’s biggest vaccine maker, put up the money to move the vaccine through a costly Phase 3 clinical trial.
But there was still the question of production: it would cost millions of dollars to start mass-producing the vaccine, and the company had no guarantee of when, or even if, it would be able to sell it. The GSK experience had cast a chill over the whole field.
The Oxford team submitted its clinical trial data for approval to the WHO right around the time the GSK shot finally cleared the last hurdle. Because the two vaccines are based on essentially the same science, this one moved much more quickly through the process. And the Serum Institute gambled big.
Those doses were made in time to be shipped in 2024, and the Serum Institute says it has the capacity to make 100 million doses per year. Even so, more than a decade after it was proved that a vaccine could protect children from malaria, only a fraction of the children at risk will get the shot this year or next. Gavi will ship about 11 million doses this year. The organization says that’s as much as countries rolling it out can handle right now.
Of academic curiosity is whether the risk-averse strategy adopted by the WHO contributed to African deaths of over 590, 000 by some estimates. However, it is almost impossible to evaluate those allegations because nobody knew we would have achieved a medical breakthrough during that time. One should not overlook spotted cases of meningitis to raise the risks with financiers holding back their purses, altogether.
Even today, African governments have not seen the urgency in their budgets to begin to produce the malaria vaccine under licence as resources are misdirected to appeasing the ruling class in terms of fancy SUVs, insane wages, overseas medical treatments and absconding health of people to foreigners. We need to wake up and sacrifice more of what we are ever to achieve anything worthwhile.
Tanzania’s budgetary allocations of 2024/25 will be razing twice on SUVs than on health insurance! That reckless expenditures prove beyond a reasonable doubt where our priorities are. The lack of a medical manufacturing base in Tanzania is a matter of preferences, not imposed.
We have money for luxuries but very little set aside for necessities like producing our own prescriptions, vaccines and medical equipment even under third-party licences. We ought to cut the fat and change the attitude that we may be self-sufficient in medical prescription equipment and vaccines.
