Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its grow­ing com­mit­ment to the con­ti­nent, Mod­er­na will sup­ply up to 110 mil­lion dos­es of its Covid-19 vac­cine to the African Union, the com­pa­ny an­nounced Tues­day. And CEO Stéphane Ban­cel said it’s just the first step.

“We be­lieve our vac­cine can play an im­por­tant role in ad­dress­ing the needs of low-in­come coun­tries giv­en its com­bi­na­tion of high Phase 3 ef­fi­ca­cy against COVID-19, strong dura­bil­i­ty in the re­al-world ev­i­dence, and su­pe­ri­or stor­age and han­dling con­di­tions. We rec­og­nize that ac­cess to COVID-19 vac­cines con­tin­ues to be a chal­lenge in many parts of the world and we re­main com­mit­ted to help­ing to pro­tect as many peo­ple as pos­si­ble around the globe,” Ban­cel said in a state­ment.

The first 15 mil­lion dos­es will come in Q4 of 2021, with an­oth­er 35 mil­lion in Q1 2022 and up to 60 mil­lion in Q2 2022. All of those dos­es will be of­fered at the com­pa­ny’s low­est tiered price. It is al­so work­ing on plans to al­low it­self to fill dos­es in Africa as ear­ly as 2023, in a mem­o­ran­dum of un­der­stand­ing that would add an ad­di­tion­al 500 mil­lion dos­es in ad­di­tion to pre­vi­ous deals with Co­v­ax through 2022.

The move comes as Mod­er­na is un­der im­mense pres­sure from the White House and pub­lic health ad­vo­cates. The com­pa­ny has large­ly ex­port­ed its shots to wealth­i­er coun­tries so far, at a time when few­er than 6% of Africa’s en­tire pop­u­la­tion has been ful­ly vac­ci­nat­ed. Just 4% of the world’s dos­es have been ad­min­is­tered in Africa.

“It’s a drop in the ocean for what the needs are,” Fa­ti­ma Has­san, the head of the Health Jus­tice Ini­tia­tive in South Africa, said of Mod­er­na’s an­nounce­ment to the New York Times. “It’s up to 110 mil­lion for a pop­u­la­tion and a con­ti­nent of 1.3 bil­lion.”

In an in­ter­view with End­points News, Ban­cel said that the vi­sion for an African man­u­fac­tur­ing site stemmed from a de­sire to treat trop­i­cal dis­eases that arose dur­ing the time he lived in Asia. Now, as the CEO of a com­pa­ny that’s dou­bled its work­force in the past year, Ban­cel says it seems dif­fi­cult to imag­ine the next 10 years of Mod­er­na with­out a pres­ence in Africa.

Ad­vo­ca­cy groups, such as Pub­lic Cit­i­zen, have called for the com­pa­ny to share its vac­cine’s in­tel­lec­tu­al prop­er­ty. Mean­while, US Pres­i­dent Joe Biden’s ad­min­is­tra­tion has ques­tioned why the num­ber of dos­es pledged to low­er- and mid­dle-in­come coun­tries are much low­er than oth­er com­pa­nies. The Times found 1 mil­lion of Mod­er­na’s dos­es have gone to coun­tries clas­si­fied as low-in­come by the World Bank, com­pared with 8.4 mil­lion from Pfiz­er and 25 mil­lion from J&J.

But Ban­cel said that among oth­er rea­sons, sup­ply con­tracts and ex­port con­trols with the US and Eu­rope are to blame for the slow ex­ports, and the size of Mod­er­na’s staff — 1,500 to­tal em­ploy­ees, com­pared with Pfiz­er’s 29,400 in the US alone — has been a con­tribut­ing fac­tor.

The con­ti­nent now has two di­rect vac­cine sup­ply deals, as it al­so has agreed to 220 mil­lion dos­es of J&J’s sin­gle-shot vac­cine, with an op­tion for 180 mil­lion more.

The com­pa­ny’s boost­er dose was al­so giv­en ap­proval by Swissmedic Tues­day for in­di­vid­u­als 12 years and old­er in pa­tients with a weak­ened im­mune sys­tem. That is to be ad­min­is­tered at least 28 days af­ter the sec­ond dose.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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