Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vac­cine ac­cess to low­er- and mid­dle-in­come na­tions has been a con­cern dur­ing the length of the pan­dem­ic, but BioN­Tech is now push­ing for­ward with plans to in­crease vac­cine ac­cess for Africa.

Con­struc­tion work has kicked off for an mR­NA man­u­fac­tur­ing fa­cil­i­ty in Ki­gali, Rwan­da. Ac­cord­ing to BioN­Tech, the fa­cil­i­ty, dubbed the African mod­u­lar mR­NA man­u­fac­tur­ing fa­cil­i­ty, has a tar­get for the first set of man­u­fac­tur­ing tools to be de­liv­ered to the site by the end of this year.

Fi­nan­cial de­tails on the project were not im­me­di­ate­ly avail­able and End­points News has reached out for com­ment.

The com­pa­ny is ex­pect­ed to es­tab­lish ad­di­tion­al fac­to­ries in Sene­gal and South Africa in close co­or­di­na­tion with its part­ners in the re­spec­tive coun­tries. How­ev­er, the ini­tial site in Rwan­da will be­come a node in a de­cen­tral­ized African end-to-end man­u­fac­tur­ing net­work. All vac­cines that will be man­u­fac­tured in these na­tions will be ded­i­cat­ed to peo­ple re­sid­ing in mem­ber states of the African Union.

Ac­cord­ing to BioN­Tech, the fa­cil­i­ty will be around 30,000 square me­ters and will be ini­tial­ly equipped with two BioN­Tain­ers, or mod­u­lar ship­ping con­tain­ers that are equipped for mR­NA pro­duc­tion. For the Ki­gali fa­cil­i­ty, one con­tain­er will be used to pro­duce mR­NA, with an­oth­er to pro­duce the for­mu­lat­ed bulk drug prod­uct. The fa­cil­i­ty will al­so be equipped to man­u­fac­ture a range of mR­NA-based vac­cines tar­get­ed to the needs of African Union mem­ber states, which could in­clude the Pfiz­er/BioN­Tech Covid-19 vac­cine and BioN­Tech’s in­ves­ti­ga­tion­al malar­ia and tu­ber­cu­lo­sis vac­cines if the vac­cines are ap­proved or au­tho­rized by reg­u­la­to­ry au­thor­i­ties.

The com­pa­ny’s malar­ia vac­cine can­di­dates will en­ter hu­man tri­als lat­er in 2022, BioN­Tech said.

The es­ti­mat­ed ini­tial an­nu­al ca­pac­i­ty of the Pfiz­er/BioN­Tech Covid-19 vac­cine will be about 50 mil­lion dos­es, the Ger­man biotech said. Man­u­fac­tur­ing in Rwan­da is ex­pect­ed to com­mence 12 to 18 months af­ter their in­stal­la­tion. The fa­cil­i­ty is al­so ex­pect­ed to em­ploy about 100 staff by 2024.

“We have reached the next mile­stone with the con­struc­tion start of the first African mR­NA man­u­fac­tur­ing fa­cil­i­ty based on our BioN­Tain­ers – just four months af­ter we in­tro­duced the BioN­Tain­er con­cept in Feb­ru­ary. This fac­to­ry will be the first in an African net­work to pro­vide sus­tain­able pro­duc­tion ca­pac­i­ty for mR­NA phar­ma­ceu­ti­cals,” said BioN­Tech CEO Uğur Şahin, in a state­ment.

Dis­cus­sions on hav­ing vac­cine man­u­fac­tur­ing ca­pa­bil­i­ties have been in the works since 2021, as pres­sure was mount­ing on Mod­er­na, BioN­Tech and its part­ner Pfiz­er to make their Covid-19 vac­cine more ac­ces­si­ble to the vast swaths of the globe still in need of dos­es.

How­ev­er, BioN­Tech is not the on­ly com­pa­ny look­ing to make a push in the African con­ti­nent. In 2021, Mod­er­na signed on to in­vest $500 mil­lion in an mR­NA man­u­fac­tur­ing site that could make up to 500 mil­lion dos­es a year. Al­so, the Mo­roc­can gov­ern­ment dropped $500 mil­lion in­to a new Re­ci­pharm fill-fin­ish plant, and Gri­fols is build­ing an IV bag plant in Nige­ria, but those projects aren’t set to be up and run­ning un­til 2023 and 2024, re­spec­tive­ly.

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In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

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Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

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Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

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Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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