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Universal Newborn Screening For Spinal Muscular at
Universal Newborn Screening For Spinal Muscular at
of production, ability to encode at a not-for-profit price. Moreover, National Food Safety Authority, Aswan Branch,
complicated protein designs, and BioNTech is working to build facilities Aswan, Egypt (AAS); Ministry of Tourism and
Antiquities, Aswan Office, Aswan 81511,
safety as immunogens, mRNA in Senegal and South Africa.1 Egypt (AAS)
vaccines are an excellent platform Currently, several mRNA vaccines 1 Saied AA. Africa is going to develop their own
for HIV vaccine development. In May, require ultra-cold chain delivery and health capabilities for future challenges—
2022, the International AIDS Vaccine storage. Investments made in ultra- correspondence. Int J Surg 2022; 99: 106585.
2 Saied AA. mRNA vaccines and clinical research
Initiative and Moderna announced cold chains for COVID-19 vaccines in in Africa—from hope to reality. Int J Surg 2022;
the first participant screenings for Africa can be repurposed into future 105: 106833.
a phase 1 clinical trial (IAVI G003) research centres and facilities for 3 Hwenda L, Sidibe M, Makanga M. The African
Medicines Agency: the key to unlocking clinical
of an mRNA HIV vaccine antigen storing new mRNA vaccines.2,4 Building research in Africa. Lancet Glob Health 2022;
(mRNA-1644) in Rwanda and South vaccine production capacities in Africa 10: e1088–89.
Africa, which is still underway, as each is still fraught with challenges, largely 4 Saied AA, Metwally AA, Dhawan M,
Choudhary OP, Aiash H. Strengthening
participant is to receive two doses of due to a scarcity of trained personnel, vaccines and medicines manufacturing
the eOD-GT8 60mer mRNA vaccine. highly specialised equipment, cold capabilities in Africa: challenges and
perspectives. EMBO Mol Med 2022; 14: e16287.
Owing to collaborative efforts chain infrastructure, power outages, 5 BioNTech. Update on first BioNTainer for
between Rwanda, Ghana, Senegal, and public health infrastructure.1,4 African-based mRNA manufacturing facility.
the African Union, WHO, and Apart from improving the cold chain 2023. https://investors.biontech.de/news-
releases/news-release-details/update-first-
the EU, Rwanda will be the first African system within the supply chain, one biontainer-african-based-mrna-
country to host an autonomous strategy for successfully stabilising manufacturing/ (accessed April 16, 2023).
6 The Lancet Infectious Diseases. Time for Africa
mRNA manufacturing facility. mRNA vaccines is lyophilisation, to future-proof, starting with COVID-19.
In June, 2022, BioNTech started which involves freeze-drying.2 Making Lancet Infect Dis 2022; 22: 151.
constructing its cutting-edge some vaccines thermostable would
manufacturing facility in Kigali eliminate their need for a cold chain,
(Rwanda) for the production of mRNA- increasing the capacity in the cold Universal newborn
based drugs and product candidates. chain for vaccines that would still
The facility is anticipated to be the first need cold or cooler temperatures. 2
screening for spinal
node in an extensive and decentralised Thermostable vaccines have been muscular atrophy in
end-to-end manufacturing network proposed as a possible way forward Ukraine
in Africa. It will initially house two sets in managing these challenges and
of BioNTainers for the synthesis of a feasible solution for increasing Spinal muscular atrophy is an
bulk mRNA vaccines.5 The Rwandan vaccination coverage in low-income autosomal recessive condition
mRNA vaccine facility is made up of and middle-income countries with characterised by progressive muscle
six bio-containers, which are mobile fluctuating energy supplies. atrophy and weakness. Spinal muscular
factories that use renewable energy to In conclusion, the commencement atrophy is caused by the deficit of SMN
run climate-neutral operations and will of large-scale mRNA vaccine protein that results with homozygous
be provided by the Rwandan company manufacturing in African countries deletion of SMN1 in 96% of patients.1
Izuba Energy. Each of the six containers is important for a real sustainable In its most frequent and severe form,
make up one BioNTainer (module) for health-care system in Africa.6 This untreated spinal muscular atrophy
drug substances and drug products.5 In manufacturing is a good opportunity leads to death or permanent ventilation
March, 2023, the first of BioNTainer’s six for enhancing vaccine training before the age of 2 years. Three drugs
ISO-sized containers were transported opportunities in African countries, that increase SMN protein through
by air to Kigali, which were finished in as the know-how is often learned in SMN2 splicing modification or SMN
Europe in December, 2022. vaccine manufacturing facilities. gene transfer are currently approved.1
Staff from BioNTech will first Rwanda has emerged as a Several trials have shown the superior
supervise and operate the facilities pioneering country, hosting the first efficacy of early treatment, leading to
and, after training local personnel, mRNA vaccine manufacturing facility newborn screening programmes in
ownership and expertise will in Africa. In the near future, Senegal, several countries2 with a large reduction
eventually be handed to local South Africa, and Kenya will be the in disease management costs.3 Because
companies, so they can take over other African countries to have mRNA the screening is based on a genetic test,
the intricate process of creating vaccine manufacturing facilities in the in contrast to traditional screening for
vaccines. Other African Union continent. metabolic and endocrine disorders,
member states will receive vaccines I declare no competing interests. newborn screening for spinal muscular
produced in the Rwanda-based atrophy leads to logistical or ethical
AbdulRahman A Saied
mRNA vaccine manufacturing facility saied_abdelrahman@yahoo.com
challenges in some countries.