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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Richard Lerner (Scott Audette/AP Images)

Richard Lern­er, an­ti­body pi­o­neer and long­time pres­i­dent of Scripps Re­search, dies at 83

Richard Lerner, the esteemed biochemist who pioneered a new way to develop monoclonal antibodies and led Scripps Research Institute to prominence, has passed away.

A spokesperson for Scripps told the San Diego Union-Tribune that Lerner died of cancer in his La Jolla home. He was 83 years old.

Among other things, Lerner’s lab was known for devising a new technique for creating antibodies — deployed as cancer treatments as well as in immunology and disease research — one that the New York Times called a “major advance in biotechnology.” It led to companies making mAbs a thousand times faster, more accurately, at a lower cost. That foundational research cemented the discovery of Humira, which went on to become the world’s best-selling treatment.