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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

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.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

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.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

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

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

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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Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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