CDC Director Rochelle Walensky, AP Images

Covid-19 roundup: CDC study con­firms re­al-world ef­fi­ca­cy of mR­NA shots; In­dia ex­port lim­its de­lay CO­V­AX ship­ments

A new re­al-world study from the CDC con­firms the high ef­fi­ca­cy lev­els and pro­tec­tive ben­e­fits of mR­NA Covid-19 vac­cines, the agency an­nounced Mon­day.

Vac­cines de­vel­oped by Pfiz­er/BioN­Tech and Mod­er­na re­duced the risk of in­fec­tion by 80% with­in two weeks af­ter tak­ing just one shot, the study said. That rate rose to 90% two weeks fol­low­ing the sec­ond sched­uled vac­ci­na­tion.

The study com­prised near­ly 4,000 health care per­son­nel, first re­spon­ders, and oth­er es­sen­tial work­ers across six states. Re­searchers looked at da­ta from Dec. 14 to March 13.

“This study shows that our na­tion­al vac­ci­na­tion ef­forts are work­ing,” CDC Di­rec­tor Rochelle Walen­sky said in a state­ment.

One of the study’s strengths, the CDC said, was its de­sign. Par­tic­i­pants self-col­lect­ed nasal swabs each week for PCR test­ing, re­gard­less of whether they had de­vel­oped symp­toms of ill­ness.

As a re­sult, re­searchers were able to de­ter­mine that the vac­cines re­duce the risk of all cas­es of Covid-19, in­clud­ing asymp­to­matic cas­es. The late-stage tri­als ex­am­in­ing the shots last year would have missed in­fec­tions with no symp­toms.

The CDC study comes a few weeks af­ter Is­rael’s health agency pre­sent­ed re­al-world da­ta show­ing the Pfiz­er/BioN­Tech shot was 94% ef­fec­tive in pre­vent­ing Covid-19. At the time of that study, the UK coro­n­avirus vari­ant was the dom­i­nant strain in the coun­try.

Mon­day’s 80% fig­ure af­ter one shot ap­pears to val­i­date some coun­tries’ ap­proach­es, such as Britain and Cana­da, of spac­ing out the first and sec­ond dos­es of the mR­NA shots in or­der to pro­vide more shots to more peo­ple in the face of lim­it­ed sup­ply. Pfiz­er and BioN­Tech have said, how­ev­er, in ref­er­ence to pre­vi­ous stud­ies, that they hadn’t eval­u­at­ed sin­gle dose reg­i­mens and such de­ci­sions were best left up to health au­thor­i­ties.  US of­fi­cials have con­tin­ued to rec­om­mend the two dos­es be giv­en on sched­ule as ad­min­is­tered in the clin­i­cal tri­als.

In­dia ex­port re­stric­tions re­sult in CO­V­AX de­lays

Coun­tries ex­pect­ing to re­ceive Covid-19 vac­cines through the eq­ui­ty pro­gram CO­V­AX were left scram­bling to find al­ter­na­tive sup­ply af­ter ma­jor con­trib­u­tor In­dia curbed ex­ports on the shots, Reuters re­port­ed Tues­day.

South Ko­rea, In­done­sia and the Philip­pines are among sev­er­al Asian coun­tries ex­pect­ing ship­ment de­lays af­ter the In­di­an mea­sures, which lim­it­ed de­liv­ery from mass pro­duc­er Serum In­sti­tute of In­dia. The man­u­fac­tur­er is the largest mak­er of the As­traZeneca/Ox­ford vac­cine, and In­di­an of­fi­cials are fo­cus­ing on meet­ing ris­ing de­mand do­mes­ti­cal­ly.

The Serum In­sti­tute was due to de­liv­er 90 mil­lion vac­cine dos­es to CO­V­AX over March and April, Reuters re­port­ed. South Ko­rea con­firmed the de­lays, with its vac­ci­na­tion task force chief not­ing it would on­ly re­ceive 432,000 of the 690,000 promised dos­es in the third week of April.

Viet­nam and the Philip­pines have al­so asked for help from their coun­tries’ pri­vate sec­tors, while In­done­sia is ex­pect­ing more than 10 mil­lion dos­es to be de­layed un­til May. In­dia has not said when it will lift the re­stric­tions.

The de­lays are push­ing some of the coun­tries to turn to­ward Chi­nese and Russ­ian vac­cines, with the Philip­pines ex­pect­ed to re­ceive its first batch of Sput­nik V in April, Reuters re­port­ed. The Philip­pines and In­done­sia are al­ready re­ly­ing heav­i­ly on shots from Chi­nese com­pa­ny Sino­vac.

In­ter­na­tion­al syn­di­cate calls for glob­al pan­dem­ic treaty

The World Health Or­ga­ni­za­tion has teamed up with the EU and more than two dozen coun­tries to call for a glob­al pan­dem­ic treaty to bet­ter pre­pare the world, and hope­ful­ly pre­vent fu­ture out­breaks.

The group pub­lished a joint ar­ti­cle in sev­er­al news­pa­pers in­ter­na­tion­al­ly call­ing for uni­ver­sal and eq­ui­table ac­cess to vac­cines, med­i­cines and di­ag­nos­tics, the New York Times was among those to re­port. Re­searchers warned that fu­ture pan­demics are in­evitable and the sort of in­ter­na­tion­al co­op­er­a­tion seen in the wake of World War II is need­ed to com­bat what lies ahead.

“There will be oth­er pan­demics and oth­er ma­jor health emer­gen­cies. No sin­gle gov­ern­ment or mul­ti­lat­er­al agency can ad­dress this threat alone,” the ar­ti­cle said. “We be­lieve that na­tions should work to­geth­er to­ward a new in­ter­na­tion­al treaty for pan­dem­ic pre­pared­ness and re­sponse.”

In ad­di­tion to vac­cine ac­cess, the let­ter al­so calls for im­proved alert sys­tems and da­ta shar­ing op­er­a­tions among coun­tries, as well as “re­spon­si­bil­i­ty, trans­paren­cy and co­op­er­a­tion with­in the in­ter­na­tion­al sys­tem and with its rules and norms.”

The ar­ti­cle did not, how­ev­er, out­line how it ex­pects to en­force vi­o­la­tions of such norms, a con­cern that has arisen dur­ing the cur­rent pan­dem­ic with Chi­na be­ing ac­cused of with­hold­ing da­ta from the WHO about the ori­gins of the pan­dem­ic. Nei­ther Chi­na nor the US has thus far signed on­to the let­ter.

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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