Boris Johnson, Chris Whitty (left) and Patrick Vallance (right) [Simon Dawson/Press Association via AP Images]

'We're led by the sci­ence': UK's plan to de­lay coro­n­avirus peak and pur­sue herd im­mu­ni­ty trig­gers up­roar

US Pres­i­dent Don­ald Trump has ex­tend­ed his Eu­rope trav­el ban to in­clude Ire­land and the UK. Spain — like Italy and France to vary­ing de­grees — is es­sen­tial­ly on lock­down. But the UK, to the dis­may of many, has tak­en what some have la­beled a com­pla­cent ap­proach.

On Thurs­day, UK Prime Min­is­ter Boris John­son, flanked by Patrick Val­lance, the gov­ern­ment’s chief sci­en­tif­ic ad­vis­er (and Glax­o­SmithK­line’s for­mer R&D chief), and the UK’s chief med­ical ad­vis­er Chris Whit­ty, kicked off a press con­fer­ence an­nounc­ing the re­gion was mov­ing on from “con­tain” phase to the “de­lay” pe­ri­od of their ac­tion plan to tack­le the epi­dem­ic on a somber note:

“I must lev­el with you, lev­el with the British pub­lic, many more fam­i­lies are go­ing to lose loved ones be­fore their time.”

These mea­sures are be­ing put in place to de­lay to the peak, and to push the peak down (or flat­ten the curve) — in an ef­fort to re­duce the bur­den on the Na­tion­al Health Ser­vice (NHS) at any giv­en point and to pro­tect the old and the vul­ner­a­ble when they need it the most, the of­fi­cials em­pha­sized.

“It’s im­por­tant to rec­og­nize it’s not to stop every­body from get­ting it, you can’t do that — it’s not pos­si­ble to stop every­body from get­ting it. And it’s al­so ac­tu­al­ly not de­sir­able, be­cause you want some im­mu­ni­ty in the pop­u­la­tion,” Val­lance said.

Rough es­ti­mates in­di­cate that herd im­mu­ni­ty — a strat­e­gy de­signed to pro­tect at-risk in­di­vid­u­als from in­fec­tion by be­ing sur­round­ed by peo­ple who are re­sis­tant to the dis­ease — to Covid-19 could be achieved if about 60% of the pop­u­la­tion has been in­fect­ed. While test­ing was broad­ly con­duct­ed at the start of the out­break, the UK has now lim­it­ed test­ing to pa­tients that are pre­sent­ing with se­vere symp­toms in hos­pi­tals.

At the con­fer­ence, John­son asked pa­tients with coro­n­avirus symp­toms, how­ev­er mild — ei­ther a new con­tin­u­ous cough or a high tem­per­a­ture — to stay at home for at least a week and ad­vised all cit­i­zens over 70 and those with se­ri­ous med­ical con­di­tions against go­ing on cruis­es and rec­om­mend­ed against in­ter­na­tion­al school trips. More se­ri­ous mea­sures, such as ask­ing cit­i­zens to stay home if some­body in the house­hold has symp­toms will like­ly be tak­en in a few weeks, the of­fi­cials said.

At this junc­ture, the re­gion will not be shut­ting down schools or im­pos­ing a quar­an­tine, the of­fi­cials said, cit­ing undis­closed sci­en­tif­ic ev­i­dence that in­di­cates such mea­sures could do more harm than good at this time.

As of Mon­day, there were more than 1500 con­firmed cas­es of Covid-19 and 35 deaths at­trib­uted to the dis­ease. “Our top num­ber for a rea­son­able worst-case sce­nario … is up to 80% of the pop­u­la­tion be­ing in­fect­ed,” Whit­ty said on Thurs­day.

Re­peat­ed­ly, the of­fi­cials said their ac­tions were guid­ed by the sci­ence — that in or­der to max­i­mize the ben­e­fit of in­ter­ven­tions, tim­ing is cru­cial. When dras­tic mea­sures are tak­en too soon, Whit­ty said, “peo­ple start off with the best of in­ten­tions, but en­thu­si­asm at a cer­tain point starts to flag.”

“It’s im­por­tant to not do things that have a rel­a­tive­ly small ef­fect, but sound sen­si­ble be­cause that puts peo­ple off from do­ing things that re­al­ly mat­ter. It’s al­so im­por­tant to do things in a way that is sus­tain­able be­cause you’re not talk­ing about mea­sures that will there for a week or two,” Val­lance added.

But an open let­ter from 500 be­hav­ioral sci­en­tists, ex­pressed con­cern. “(W)e are not con­vinced that enough is known about ‘be­hav­ioral fa­tigue’ or to what ex­tent these in­sights ap­ply to the cur­rent ex­cep­tion­al cir­cum­stances,” it said. “Such ev­i­dence is nec­es­sary if we are to base a high-risk pub­lic health strat­e­gy on it.”

The UK gov­ern­ment’s re­sponse to the bur­geon­ing epi­dem­ic has trig­gered a spate of neg­a­tive head­lines with crit­ics pan­ning the ap­proach as in­suf­fi­cient and dan­ger­ous. To add in­sult to in­jury, late on Thurs­day Ar­se­nal Foot­ball Club man­ag­er Mikel Arte­ta an­nounced he had test­ed pos­i­tive for the virus, and soon af­ter news that play­ers from oth­er clubs had been in­fect­ed be­gan to sur­face. Even­tu­al­ly, the Pre­mier League said it would sus­pend games un­til April 3, amid oth­er sus­pen­sions across oth­er sport­ing events.

In an open let­ter pub­lished on Sat­ur­day from over 200 sci­en­tists, in­clud­ing PhD stu­dents, in dis­ci­plines rang­ing from math­e­mat­ics to ar­ti­fi­cial in­tel­li­gence (but no re­searchers who study the sci­ence of dis­ease spread) sug­gest­ed the UK gov­ern­ment was do­ing too lit­tle and risk­ing lives in its pur­suit of ‘herd im­mu­ni­ty,’ giv­en that the cur­rent da­ta on in­fec­tions in the UK is in line with the growth curves al­ready seen else­where, such as Italy, Spain, France and Ger­many.

“Un­der un­con­strained growth, this out­break will af­fect mil­lions of peo­ple in the next few weeks. This will most prob­a­bly put the NHS at se­ri­ous risk of not be­ing able to cope with the flow of pa­tients need­ing in­ten­sive care, as the num­ber of ICU beds in the UK is not larg­er than that avail­able in oth­er neigh­bor­ing coun­tries with a sim­i­lar pop­u­la­tion,” they wrote.”Go­ing for ‘herd im­mu­ni­ty’ at this point does not seem a vi­able op­tion, as this will put NHS at an even stronger lev­el of stress, risk­ing many more lives than nec­es­sary.”

Richard Hor­ton, ed­i­tor-in-chief of The Lancet, ac­cused the UK gov­ern­ment of play­ing roulette with the pub­lic. An­oth­er con­cern­ing let­ter al­so sur­faced from the British So­ci­ety of Im­munol­o­gy. An­tho­ny Costel­lo, pro­fes­sor of glob­al health and sus­tain­able de­vel­op­ment at Uni­ver­si­ty Col­lege Lon­don and a for­mer di­rec­tor of ma­ter­nal and child health at the WHO, told the Guardian that mean­while, Chi­na mount­ed a “prop­er” cam­paign to stop the epi­dem­ic in its tracks, as laid out by the WHO — test in­ten­sive­ly, trace con­tacts, quar­an­tine and main­tain so­cial dis­tanc­ing.

“They didn’t leave it all to mes­sages and nudge be­hav­ioral meth­ods,” he wrote in a scathing ed­i­to­r­i­al. “With­out an all-out na­tion­al mo­bi­liza­tion for so­cial dis­tanc­ing, are the be­hav­ioral and nudge strate­gies re­al­ly ev­i­dence-based to flat­ten the peak? Or sim­ply based on mod­els? Why are we em­pha­siz­ing herd im­mu­ni­ty now? Does coro­n­avirus in­duce strong herd im­mu­ni­ty or is it like flu, where im­mu­ni­ty re­mains weak and new strains emerge each year? We have much to learn about Covid-19 im­mune re­spons­es.”

Matt Han­cock UK Par­lia­ment

Mean­while, calls for trans­paren­cy on the sci­en­tif­ic ad­vice and mod­els the UK gov­ern­ment is us­ing to make its de­ter­mi­na­tions gath­ered steam.

In an ex­change with Sec­re­tary of State for Health and So­cial Care Matt Han­cock, Sky News jour­nal­ist So­phy Ridge said: “You said that this is based on the best sci­en­tif­ic ad­vice, so why don’t you trans­par­ent­ly pub­lish that ad­vice and the gov­ern­ment’s mod­el­ing … be­cause if you’re so con­vinced you’re fol­low­ing the sci­ence, why don’t you pub­lish it so that peo­ple can take it on their own knowl­edge, rather than trust?”

Han­cock said the da­ta would be pub­lished in the com­ing days, but ap­peared to back away from the goal of herd im­mu­ni­ty, which had been al­lud­ed to by UK of­fi­cials at the press con­fer­ence days ear­li­er.

“Herd im­mu­ni­ty is not our goal or pol­i­cy, it’s a sci­en­tif­ic con­cept. Our pol­i­cy is to save lives and beat this virus,” he said, adding that gov­ern­ment is gear­ing up to ask Britons over 70 to iso­late for “months,” with­in weeks.

The UK gov­ern­ment has since al­so an­nounced it will be con­duct­ing dai­ly brief­in­gs to up­date the pub­lic.

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?

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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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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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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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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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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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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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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