Covid-19 roundup: The pan­dem­ic bear — You think a vac­cine and herd im­mu­ni­ty are just months away? Dream on, says biotech an­a­lyst; plus more

You’ve all heard the rosiest sce­nar­ios by now.

Vac­cines are rac­ing through clin­i­cal de­vel­op­ment at un­heard-of speed, helped along by reg­u­la­tors work­ing round the clock to beat Covid-19. And man­u­fac­tur­ers have been lay­ing the ground­work for mass pro­duc­tion ahead of Phase I re­sults.

The first wave of jabs and meds could break in a mat­ter of months. With the NIH en­dors­ing such re­marks as “We’ll have a vac­cine by Sep­tem­ber,” every­one from law­mak­ers to in­vestors and the gen­er­al pub­lic have been will­ing to buy in­to the no­tion that sal­va­tion lies right around the cor­ner.

Then along comes a promi­nent an­a­lyst to pour a buck­et of cold wa­ter on your hope of turn­ing the tide by Christ­mas.

SVB Leerink’s Ge­of­frey Porges took stock of the promise of glob­al pan­dem­ic re­lief and of­fered to burst that lit­tle bub­ble for free.

For Porges, the on­ly thing that lies around the cor­ner is … an­oth­er cor­ner. And then more cor­ners. The path to a vac­cine is long and hard, he notes. And the re­al­i­ty of that should be fac­tored in as we size up the fu­ture.

In our ex­pe­ri­ence it is very un­like­ly that we will have a gen­er­al use vac­cine in the 6-18 month ac­cel­er­at­ed time­frame that is be­ing dis­cussed. We be­lieve that a 2-3 year time­line is the most op­ti­mistic for see­ing a gen­er­al use vac­cine in­tro­duced, and as im­por­tant­ly, in the re­mote pos­si­bil­i­ty that an ap­proved, ef­fec­tive, safe gen­er­al use vac­cine was avail­able a year from now, it would still take sev­er­al years to con­fer suf­fi­cient “herd im­mu­ni­ty” to pre­vent en­dem­ic spread of COVID19. We be­lieve that achiev­ing herd im­mu­ni­ty suf­fi­cient to pre­vent epi­dem­ic spread is like­ly to oc­cur in 2023 or 2024, giv­en a high­ly ac­cel­er­at­ed time­line for vac­cine de­vel­op­ment in­clud­ing demon­stra­tion of safe­ty and ef­fi­ca­cy in hu­mans, and then de­sign, de­vel­op­ment and im­ple­men­ta­tion of a mass im­mu­niza­tion pro­gram suf­fi­cient to get to a 70-80% im­mune thresh­old.

And that, he adds, is his “op­ti­mistic” pro­jec­tion. It could be much, much worse.

Sure, there are more than 70 vac­cine pro­grams go­ing on now. But for Porges, if you add it all up, it’s like hand­ing some­one a dart and giv­ing them 1 chance to hit a bulls eye at 24 feet — 3 times the reg­u­la­tion dis­tance. He’s al­so not en­thu­si­as­tic that the clos­est vac­cines to re­al­i­ty — like the mR­NA vac­cines — can pass muster quick­ly, as they are com­plete­ly un­proven.

Add to that a new virus we don’t com­plete­ly un­der­stand and you get a bet­ter idea of where Porges is com­ing from.

We do have the lux­u­ry of many dif­fer­ent shots on goal with 70+ pro­grams un­der­way (to mix our sport­ing metaphors), but each one of these on­ly has the same low prob­a­bil­i­ty and most of them can’t de­liv­er on the op­ti­mistic time­lines now dom­i­nat­ing pol­i­cy mak­er’s and in­vestor’s out­looks.

The on­ly re­al shot at get­ting a vac­cine in­to fast use is by re­quir­ing peo­ple to take a shot of some­thing that no one knows the full sto­ry on — with safe­ty and ef­fi­ca­cy iffy at best, notes the an­a­lyst. And that in­cludes im­mu­niz­ing low-risk peo­ple for the sake of the old­er gen­er­a­tion.

So give it 2-3 years for an ef­fec­tive vac­cine, then 1-3 years for herd im­mu­ni­ty. — John Car­roll

Alex­ion plots quick PhI­II to eval­u­ate whether Ul­tomiris can boost sur­vival rates

Al­most a month af­ter in­di­cat­ing it’s look­ing in­to test­ing its star C5 in­hibitor Soliris for hos­pi­tal­ized pa­tients with Covid-19, Alex­ion is go­ing straight in­to Phase III with its fol­low-up drug, Ul­tomiris. The study will in­volve around 270 pa­tients suf­fer­ing from se­vere pneu­mo­nia, acute lung in­jury or acute res­pi­ra­to­ry dis­tress syn­drome and in­ves­ti­gate whether Ul­tomiris can help them sur­vive past 29 days.

The de­ci­sion was based on “ear­ly anec­do­tal in­for­ma­tion avail­able from com­pas­sion­ate use cas­es in mul­ti­ple coun­tries” as well as pre­clin­i­cal da­ta sug­gest­ing that in­hi­bi­tion of ter­mi­nal com­ple­ment can low­er cy­tokine and chemokine lev­els, there­by re­duc­ing lung in­flam­ma­tion.

In the Phase III tri­al — which will in­clude a con­trol arm re­ceiv­ing best sup­port­ive treat­ment — in­ves­ti­ga­tors will al­so as­sess the need for me­chan­i­cal ven­ti­la­tion, oxy­gena­tion, du­ra­tion of ICU stay and hos­pi­tal­iza­tion, in ad­di­tion to safe­ty as sec­ondary end­points. Mean­while Alex­ion is still run­ning an ex­pand­ed ac­cess pro­gram in the US and France for Soliris. — Am­ber Tong

So­ci­ety needs to pitch in to shore up drug, vac­cine man­u­fac­tur­ing

Apart from de­vel­op­ing an ef­fi­ca­cious and safe vac­cine, a com­pa­ny’s abil­i­ty to man­u­fac­ture the vac­cine swift­ly is para­mount. Ex­perts, in­clud­ing NI­AID di­rec­tor An­tho­ny Fau­ci, have stressed that the best strat­e­gy is for mak­ers to shore up man­u­fac­tur­ing even be­fore they have con­crete ev­i­dence of ef­fi­ca­cy so that vac­cines can be de­ployed quick­ly and wide­ly if proven to be safe and po­tent.

Now, chiefs of phar­ma­ceu­ti­cal com­pa­nies are ask­ing gov­ern­ments to work to­geth­er and pro­vide sub­stan­tial fund­ing to as­sist with shoring up pro­duc­tion. “In­dus­try alone can’t pro­vide all the in­vest­ment need­ed now for bil­lions of dos­es,” Sanofi EVP David Loew said in an in­ter­view with the Fi­nan­cial Times.

Apart from vac­cines, there is a glob­al des­per­a­tion for raw ma­te­ri­als for ex­ist­ing treat­ments be­ing re­pur­posed and test­ing. Of par­tic­u­lar con­cern are de­vel­op­ing poor­er na­tions, whose ac­cess to med­ical sup­plies is lim­it­ed by scant­er re­sources. Ex­ec­u­tives al­so wor­ry that the Covid-19 sit­u­a­tion will echo what hap­pened in the af­ter­math of pre­vi­ous out­breaks, such as Ebo­la and the 2009 flu pan­dem­ic — as the dust be­gan to set­tle, com­pa­nies strug­gled to main­tain fund­ing to de­vel­op po­ten­tial drugs and vac­cines for fu­ture out­breaks af­ter gov­ern­ments cut them off.

“The in­vest­ment re­quired is too large for any com­pa­ny,” said Take­da chief Christophe We­ber to the FT. “So­ci­ety will have to fi­nance this huge in­vest­ment. My fear is the same as af­ter the flu pan­dem­ic, when every­body los­es in­ter­est.” — Na­tal­ie Grover

Trump ad­vi­sor Navar­ro as­serts Chi­na is with­hold­ing da­ta to win vac­cine race 

On Sun­day, White House ad­vi­sor Pe­ter Navar­ro took to Fox News to ac­cuse Chi­na of tak­ing a suite of ac­tions to wors­en the on­go­ing coro­n­avirus cri­sis.

“First of all, the virus was spawned in Chi­na. Sec­ond of all, they hid the virus be­hind the shield of the World Health Or­ga­ni­za­tion. The third thing they did was ba­si­cal­ly hoard per­son­al pro­tec­tive equip­ment and now they’re prof­i­teer­ing from it,” Navar­ro said on Fox News pro­gram Sun­day Morn­ing Fu­tures.

The out­spo­ken crit­ic of Chi­na, who has been tasked by Pres­i­dent Trump to work on sup­ply is­sues re­lat­ing to the  pan­dem­ic, on Mon­day sug­gest­ed on Fox News that the coun­try is with­hold­ing da­ta about ear­ly coro­n­avirus in­fec­tions in or­der to be the first to de­vel­op a vac­cine.

“One of the rea­sons that they may not have let us in and giv­en us the da­ta on this virus ear­ly, is they’re rac­ing to get a vac­cine and they think this is just a com­pet­i­tive busi­ness race, it’s a busi­ness propo­si­tion so that they can sell the vac­cines to the world,” he said.

The race to de­vel­op a vac­cine has heat­ed up, with Chi­na’s CanSi­no as one of a hand­ful of de­vel­op­ers with a vac­cine in hu­man test­ing. — Na­tal­ie Grover

Brazil hy­drox­y­chloro­quine tri­al sus­pend­ed due to eth­i­cal con­cerns 

A new study from Brazil, which sug­gest­ed the com­bi­na­tion of hy­drox­y­chloro­quine and azithromycin had a sig­nif­i­cant­ly pos­i­tive im­pact on ear­ly-stage sus­pect­ed Covid-19 cas­es, was post­ed as a pre­lim­i­nary man­u­script draft on Drop­box last week.

On Mon­day, the tri­al was sus­pend­ed by the Na­tion­al Com­mis­sion for Ethics in Re­search (Conep) af­ter the agency dis­cov­ered that test­ing was ini­ti­at­ed be­fore the com­pa­ny, a São Paulo-based hos­pi­tal chain, re­ceived the green­light to car­ry out the re­search. The re­searchers in charge were sum­moned for a hear­ing this Mon­day af­ter­noon with the agency to pro­vide clar­i­fi­ca­tion on sus­pect­ed ir­reg­u­lar­i­ties, ac­cord­ing to a re­port.

There were a num­ber of in­con­sis­ten­cies iden­ti­fied. For one, re­searchers had told Conep that pa­tients with a con­firmed di­ag­no­sis of Covid-19 would be in­clud­ed in the tri­al, but the man­u­script re­leased sug­gest­ed that par­tic­i­pants dis­play­ing flu-like symp­toms with­out con­firmed Covid-19 in­fec­tions were in­clud­ed in the tri­al. Ini­tial­ly, the re­searchers al­so in­di­cat­ed the tri­al would en­roll 200 par­tic­i­pants, but the man­u­script the num­ber was clos­er to 700, the re­port said. — Na­tal­ie Grover

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

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”