Covid-19 roundup: Mod­er­na pass­es 100M mark for US vac­cines in land­mark mo­ment; Fake Pfiz­er vac­cine found in Mex­i­co

Mod­er­na an­nounced that it shipped its 100-mil­lionth dose of its Covid-19 vac­cine in the US on Mon­day. So far, 67 mil­lion dos­es have been ad­min­is­tered in the US, a state­ment said.

Ship­ments to the US gov­ern­ment have in­creased five­fold since the FDA’s emer­gency use au­tho­riza­tion Dec. 18, from 16 mil­lion dos­es to 88 mil­lion dos­es. Mod­er­na ex­pects to ship an­oth­er 40-50 mil­lion dos­es a month to the US gov­ern­ment, ac­cord­ing to a state­ment.

In all, Mod­e­na will have shipped 300 mil­lion dos­es of the vac­cine to the US by the end of Ju­ly 2021, the com­pa­ny said. The vac­cine has been au­tho­rized for use in Cana­da, Is­rael, Switzer­land, Sin­ga­pore, Qatar, the UK and the Eu­ro­pean Union, in ad­di­tion to the US.

To keep up with the de­mand for the vac­cine, Mod­er­na has been in­vest­ing heav­i­ly in man­u­fac­tur­ing op­er­a­tions. In ear­ly March, the com­pa­ny signed a deal with Bax­ter Bio­Phar­ma So­lu­tions to help pro­duce the vac­cine, in an ef­fort to quick­ly scale up. Man­u­fac­tur­ing orig­i­nal­ly start­ed in Mod­er­na’s Boston fa­cil­i­ty in 2020, im­me­di­ate­ly af­ter the com­pa­ny was grant­ed EUA.

Fal­si­fied Pfiz­er vac­cine de­tect­ed in Mex­i­co

A fal­si­fied Pfiz­er-BioN­Tech vac­cine was de­tect­ed in Mex­i­co, ac­cord­ing to the World Health Or­ga­ni­za­tion.

The fake vac­cines were giv­en to pa­tients out­side of au­tho­rized vac­cine pro­grams, and may still be in cir­cu­la­tion in the area.

Pfiz­er con­firmed that its sci­en­tists did not man­u­fac­ture the prod­uct and the batch num­ber and ex­piry dates were fal­si­fied. The vials and la­bel are al­so re­port­ed­ly dif­fer­ent than gen­uine BNT162b2 vials.

NIH Di­rec­tor Fran­cis Collins talks vac­cine skep­ti­cism in in­ter­view

In an in­ter­view with The Hill pub­lished Sat­ur­day, NIH Di­rec­tor Fran­cis Collins said that hes­i­tan­cy will be the “defin­ing fac­tor” whether or not the US reach­es herd im­mu­ni­ty and em­pha­sized the dan­ger of clas­si­fy­ing the vac­cine-skep­ti­cal pop­u­la­tion as a sin­gle ho­mo­ge­neous group.

Peo­ple of faith — par­tic­u­lar­ly white evan­gel­i­cals — some­times doubt that they need any­thing oth­er than God to take care of them, Collins said. Oth­ers who con­sid­er them­selves pro-life wor­ry that vac­cines con­tain a fe­tal cell line. Among the African-Amer­i­can com­mu­ni­ty, Collins said there is skep­ti­cism about whether the health­care sys­tem has in­di­vid­u­als’ best in­ter­ests at heart and cit­ed the lack of ethics in­volved in the Tuskegee Study in the 1930s.

“In every in­stance what I’ve learned is if some­body says they’re hes­i­tant, the first thing I want to know is, tell me about that. Tell me what it is that has you trou­bled. Is it the con­spir­a­cy the­o­ries you’ve been hear­ing? And there’s plen­ty of those out there on so­cial me­dia. Is it your con­cern about safe­ty is­sues not hav­ing been ful­ly ad­dressed? Is it some oth­er fac­tor that’s in there?” Collins said. “And there’s no sin­gle, I think, best re­sponse un­til you’ve lis­tened to hear what the ba­sis of the hes­i­tan­cy is and that per­son.”

J&J notch­es African vac­cine sup­ply deal

J&J’s Janssen will make up to 220 mil­lion dos­es of its sin­gle-shot Covid-19 vac­cine avail­able to the African Union’s 55 mem­ber states in an agree­ment an­nounced Mon­day.

The African Vac­cine Ac­qui­si­tion Trust will al­so have an op­por­tu­ni­ty to or­der an ad­di­tion­al 180 mil­lion dos­es through 2022.

“From the be­gin­ning of this pan­dem­ic, John­son & John­son has rec­og­nized that no one is safe un­til every­one is safe, and we have been com­mit­ted to eq­ui­table, glob­al ac­cess to new COVID-19 vac­cines,” CEO Alex Gorsky said in a state­ment.

In De­cem­ber, J&J en­tered in­to an agree­ment to sup­port the CO­V­AX fa­cil­i­ty, which pro­vides eq­ui­table ac­cess to vac­cines for coun­tries in need. The com­pa­ny’s plan is to en­ter a deal that would pro­vide Gavi with up to 500 mil­lion dos­es of the vac­cine to CO­V­AX through 2022.

The in­creased ur­gency to get peo­ple vac­ci­nat­ed in Africa comes with the emer­gence and spread of the South African Covid-19 vari­ant.

When asked, a J&J spokesper­son did not re­veal the fi­nan­cial terms of the deal on Mon­day.

First round of As­traZeneca vac­cine de­liv­ered to Mex­i­co

The first 1.5 mil­lion dos­es of As­traZeneca’s Covid-19 vac­cine were de­liv­ered to Mex­i­co from the US on Sun­day, Reuters re­ports.

This was the first round of 2.7 mil­lion dos­es that Pres­i­dent Joe Biden promised the coun­try to help deal with lo­cal short­ages. Mex­i­co’s pop­u­la­tion is 126 mil­lion.

Ear­li­er in March, Biden turned down’s Mex­i­can Pres­i­dent Lopez Obrador’s re­quest for dos­es, which led the coun­try to turn to Chi­na for an ad­di­tion­al 22 mil­lion.

The new agree­ment comes as the US has seen a surge of Cen­tral Amer­i­can im­mi­grants at its south­ern bor­der. Though not con­sid­ered a quid pro quo, ac­cord­ing to The Wash­ing­ton Post, the US will of­fer up vac­cines as Mex­i­can of­fi­cials promise to help step up im­mi­gra­tion en­force­ment.

Cana­di­an Prime Min­is­ter Justin Trudeau has al­so asked Biden to help out with the coun­try’s vac­cine short­age in re­cent talks, the Post re­ports.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, 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.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Mer­ck scraps their $425M Covid-19 drug in lat­est pan­dem­ic set­back

Seven months after paying $425 million cash to acquire it, Merck is scrapping a Covid-19 drug they hoped could provide one of the only treatments for severe hospitalized patients.

Merck’s decision comes after they faced significant and unexpected regulatory delays in getting the drug, known as MK-7110 or CD24Fc, across the finish line. The Big Pharma licensed the drug under the belief that it had already shown sufficient benefit in severe patients and they could help scale it up far faster than OncoImmune, its former owner, could. But in February, the company reported that the FDA insisted Merck run a new trial before seeking authorization.

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Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Look­ing to ce­ment its lead in packed MS mar­ket, Roche's Ocre­vus un­corks new da­ta in ear­ly-stage pa­tients

Among a positively jam-packed multiple sclerosis market, Roche’s Ocrevus has managed to stand out for what the Swiss drugmaker is calling the most successful launch in its long history. But in order to press its advantage, Ocrevus is looking to earlier-stage patients, and new interim data should help build its case there.

After 48 weeks on Roche’s Ocrevus, 85% of newly diagnosed primary progressing or relapsing MS patients without a history of disease modifying therapy posted no disease activity, including disease progression or relapse, according to interim data set to be presented this weekend at the virtual American Academy of Neurology meeting.