Covid-19 roundup: As­traZeneca vac­cine halt­ed in Ger­many for be­low-60 pop­u­la­tion; Pfiz­er says Covid-19 vac­cine has 100% ef­fi­ca­cy in chil­dren ages 12-15

Ger­many will stop us­ing As­traZeneca’s Covid-19 vac­cine on res­i­dents be­low the age of 60 due to con­cerns sur­round­ing “rare but fa­tal blood clots,” ac­cord­ing to the Wash­ing­ton Post.

Chan­cel­lor An­gela Merkel said Tues­day that the gov­ern­ment can­not ig­nore the rec­om­men­da­tion from Ger­many’s vac­cine com­mit­tee. The Paul Ehrlich In­sti­tute re­port­ed 31 cas­es of ve­nous throm­bo­sis, a brain clot that can lead to he­m­or­rhag­ing.

With ve­nous throm­bo­sis, the vein that drains blood from the brain is blocked, which can lead to dead­ly bleed­ing in the brain. The pa­tients in all 31 cas­es had low lev­els of platelets. That leads to clot­ting.

Those 31 cas­es hap­pened among the 2.7 mil­lion peo­ple in the coun­try that re­ceived As­traZeneca’s virus.

Nine peo­ple have died, the Post re­ports. Every­one who ex­pe­ri­enced the brain clot was younger than 63, and all but two of those re­port­ed cas­es were in women.

A group of clot­ting spe­cial­ists led by An­dreas Greinach­er of the Uni­ver­si­ty of Greif­swald say that the side ef­fects are sim­i­lar to those of the blood thin­ner he­parin called he­parin-in­duced throm­bo­cy­tope­nia (HIT), Sci­ence re­port­ed.

As­traZeneca’s vac­cine has been un­der scruti­ny af­ter pool­ing da­ta from dif­fer­ent and re­lease con­flict­ing ef­fi­ca­cy num­bers last fall. In some of those an­nounce­ments, the vac­cine ap­peared po­ten­tial­ly far less ef­fec­tive than the Pfiz­er/BioN­Tech and Mod­er­na’s re­ports of 95% and 94.5%.

Last week, the DSMB charged with over­see­ing the tri­al alert­ed of­fi­cials at the NIH that As­traZeneca had ig­nored its rec­om­men­da­tion to tell the pub­lic that the da­ta they were see­ing in Feb­ru­ary and March in­di­cat­ed a rate of 69% to 74%. That led NIH di­rec­tor An­tho­ny Fau­ci to go on ABC’s Good Morn­ing Amer­i­ca and call the move an “un­forced er­ror.”

“The fact is this is very like­ly a very good vac­cine,” Fau­ci said. “This kind of thing does … re­al­ly cast some doubt about the vac­cines and maybe con­tribute to the hes­i­tan­cy. It was not nec­es­sary.”

The com­pa­ny has ad­just­ed the ef­fi­ca­cy rate of its vac­cine to 76% to 79%.

Pfiz­er says Covid-19 vac­cine has 100% in chil­dren ages 12-15

A Phase III tri­al of Pfiz­er and BioN­Tech’s Covid-19 vac­cine has demon­strat­ed 100% ef­fi­ca­cy in chil­dren be­tween the ages of 12 and 15, Pfiz­er an­nounced Wednes­day. Those re­sults ex­ceed ef­fi­ca­cy num­bers record­ed ear­li­er re­port­ed in par­tic­i­pants be­tween the ages of 16 and 25 years old, the com­pa­ny stat­ed in a re­lease.

The tri­al — which con­sist­ed of 2,260 ado­les­cents be­tween the ages of 12 and 15 — saw 18 cas­es of Covid-19 ap­pear in the place­bo group, and none in the vac­ci­nat­ed group, Pfiz­er said. The com­pa­ny plans to sub­mit the da­ta for the FDA and EMA for an amend­ment to the EUA of the vac­cine.

“Across the globe, we are long­ing for a nor­mal life. This is es­pe­cial­ly true for our chil­dren,” said BioN­Tech CEO Ugur Sahin in a state­ment. “The ini­tial re­sults we have seen in the ado­les­cent stud­ies sug­gest that chil­dren are par­tic­u­lar­ly well pro­tect­ed by vac­ci­na­tion.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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Image: Shutterstock

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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Joe Biden (Carolyn Kaster, AP Images)

Covid-19 roundup: Biden in­vests $1.7B to ad­dress Covid vari­ants; EU puts faith in Pfiz­er with new vac­cine deals

The Biden administration said Friday that it’ll pump $1.7 billion into various programs to address Covid-19 variants as the original strain of Covid-19 makes up only about half of all US cases today.

Most of those new funds, $1 billion in total, will go to expand genomic sequencing so the CDC, states and other jurisdictions can improve their capacity to identify Covid mutations and monitor the circulation of variants. Back in February, US labs were only sequencing about 8,000 Covid-19 strains per week, although the rate of sequencing has increased substantially since then, the administration said.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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