In October 2021, The World Health Organisation (WHO) approved the world’s first ever malaria vaccine. The WHO’s director general, and ex-malaria vaccine researcher, Dr Tedros Adhanom Ghebreyesus, granted its rollout after a successful pilot programme distributing more than 800,000 vaccines to children across Ghana, Kenya and Malawi since 2019. Experts hope this move can save tens of thousands of children’s lives each year across Africa, with the RTS,S vaccine also on its way to becoming available for broad use in other global markets.
Developed by British pharmaceutical company GlaxoSmithKline (GSK), the RTS,S vaccine, also known as Mosquirix, has been approved for manufacture by only one partner in India – Bharat Biotech (BBIL). GSK have committed to supplying 15 million doses up to 2028, after which BBIL will take over production and manufacturing. I am intrigued to see the approach when it comes to the logistics of rolling out this vaccine, which is bound to spur huge market growth opportunities across the globe.
In the wake of the pandemic, discussions around the logistics, cost and efficiency of vaccine rollouts remains a hot topic. For example, the EU’s medicines regulator recently approved new manufacturing sites for Pfizer-BioNTech, Moderna and AstraZeneca-Oxford coronavirus vaccines in a move to significantly boost Europe's supply and speed of vaccination distribution. The EMA went on to approve factories in Leiden, the Netherlands, to make the active substance for AstraZeneca's vaccine, bringing the number of sites to four. Approval for an additional site in Marburg, Germany to manufacture BioNTech and Pfizer vaccines closely followed. At the time of approval, 400 BioNTech employees were placed in Marburg to maximise production output.
French drugmaker Sanofi similarly approved a 400-million-euro investment in a Singapore-based vaccine production site over a five-year period. The new site aims to provide Sanofi with the ability to produce innovative vaccines on a massive scale for the Asian market, as well as create preventative responses to future pandemic risks, and is expected to provide up to 200 local jobs.
When reflecting on previous cases, such as Takeda’s Dengue vaccine programme in 2019, it is clear that immediate scalability is not always a smooth process. After initial success spurred expansion into a new plant in Singen, Germany following initial clinical trials in 2016, Takenda still hit bumps in the road when it came to roll out. After side effects occurred with phase 2 testing, distribution ground to a halt before reaching its goal to launch end-to-end production and licensure in 2019.
Mosquirix targets the deadliest malaria parasite, Plasmodium falciparum, most common in Africa. To be effective, four doses of the vaccine must be administered, beginning as young as 5 months old. This vast requirement is more than likely to pose logistical problems, as delivering vaccines across Africa already proves a challenge.
The combined risk of biological and physical variability makes vaccine manufacturing more challenging than typical small molecule pharmaceuticals as a high proportion of vaccine manufacturers suffer with supply shortages. This explains the reason the number of successful vaccine manufacturers remains low, despite vast demand for global vaccines.
Arguably, vaccination manufacturing should take place in the country of distribution – namely Africa for the recently approved malaria jab. The AVMI, for example, aim to mobilise Africa through manufacture of preventive and therapeutic vaccines required to fight diseases of public health importance. They encourage partnerships between African vaccine manufacturers and stakeholders who share this vision in an aim to facilitate logistics challenges.
BBIL are making huge industry moves when it comes to facilitating vaccine distribution, with the recent WHO approval of their Covaxin now in full swing for distribution across India and Asia.
The Mosquirix agreement between GSK and BBIL aims to help ensure long-term sustainable vaccine supply, in the event of a WHO policy recommendation for broader use and a commitment of sustained funding. In a joint statement, they said:
The agreement recognises the track record and expertise of BBIL in developing and supplying vaccines against infectious diseases, including as an established supplier of global health vaccines.
There is now an undeniable race to begin official distribution, however it will take a few years to achieve an effective rhythm and create real global impact – with a predicted focus to prevent at least 40% of malaria cases per year. For me the question still stands, what happens after 2028? There is no question that BBIL are industry-leading vaccine distributors, but it is equally clear that the logistics of vaccine distribution in Africa is a tough nut to crack, therefore a thorough expansion and distribution plan for this vaccine’s future is imperative to tackle this life-threatening disease.
The market is certainly set to expand at massive pace from here on out, but where will the next big step lead? If you’re interested in discussing this in some more detail with me, drop me a message at firstname.lastname@example.org.
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