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.

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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