Covid-19 roundup: EMA be­gins rolling re­view of first Chi­nese vac­cine; Af­ter 100% ef­fi­ca­cy tri­al, teenagers could be el­i­gi­ble for Pfiz­er's vac­cine next week

Sino­vac’s shot — which was just ef­fec­tive enough to meet reg­u­la­to­ry stan­dards — is now the first Chi­nese Covid-19 vac­cine to be con­sid­ered by the Eu­ro­pean Med­i­cines Agency.

The EMA’s hu­man med­i­cines com­mit­tee (CHMP) said on Tues­day that it’s kick­ing off a rolling re­view of the in­ac­ti­vat­ed vac­cine, dubbed Coro­n­aVac in some re­gions, in an at­tempt to speed up the reg­u­la­to­ry process. The agency will look at da­ta as they be­come avail­able to de­ter­mine whether the ben­e­fits of the jab out­weigh the risks.

Hun­gary be­came the first coun­try in the EU to al­low emer­gency use of the shot back in Jan­u­ary, fol­low­ing a gov­ern­ment de­cree that any vac­cine giv­en to at least a mil­lion peo­ple world­wide can now be ap­proved for use with­out pass­ing through the coun­try’s med­i­cines reg­u­la­tor, ac­cord­ing to the AP.

In Feb­ru­ary, Sino­vac an­nounced the can­di­date was just 50.65% ef­fec­tive against all Covid-19 cas­es in Phase III stud­ies con­duct­ed in Brazil and Turkey in health­care work­ers. The biotech said ef­fi­ca­cy was 83.70% for cas­es re­quir­ing med­ical treat­ment, and 100.00% for hos­pi­tal­ized, se­vere, and fa­tal cas­es.

It should be not­ed that in an analy­sis of 29 cas­es among par­tic­i­pants who be­longed to the gen­er­al pub­lic in Turkey, Sino­vac says its can­di­date was 91.25% ef­fec­tive at Covid-19 pre­ven­tion 14 days af­ter the two-dose vac­ci­na­tion.

“EMA will as­sess the com­pli­ance of COVID-19 Vac­cine (Vero Cell) In­ac­ti­vat­ed with the usu­al EU stan­dards for ef­fec­tive­ness, safe­ty and qual­i­ty,” the EMA said in a state­ment.

Coro­n­aVac was one of the vac­cines au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment in Ju­ly, ac­cord­ing to a Reuters re­port cit­ing an un­named of­fi­cial. The can­di­dates were ad­min­is­tered to some med­ical pro­fes­sion­als and bor­der of­fi­cers, a Chi­nese of­fi­cial said in an in­ter­view with state me­dia. — Nicole De­Feud­is

Af­ter 100% ef­fi­ca­cy tri­al, teenagers could be el­i­gi­ble for Pfiz­er’s vac­cine next week

Teenagers be­tween the ages of 12 and 15 could be el­i­gi­ble to re­ceive the Pfiz­er-BioN­Tech Covid-19 vac­cine as ear­ly as next week, The New York Times has re­port­ed. The com­pa­ny re­leased its tri­al re­sults to­ward the end of March, and found that no symp­to­matic in­fec­tions oc­curred in pa­tients with­in this age group.

The an­nounce­ment is a step to­ward an at­tempt at reach­ing herd im­mu­ni­ty. In Feb­ru­ary, NI­AID di­rec­tor An­tho­ny Fau­ci said that chil­dren as young as first graders could be el­i­gi­ble for the vac­cine by the time school starts in Sep­tem­ber. That el­i­gi­bil­i­ty is like­ly to ease the minds of ed­u­ca­tors across the coun­try, who have grap­pled with the del­i­cate bal­ance of pro­vid­ing an ad­e­quate ed­u­ca­tion for stu­dents and pro­vid­ing a safe work en­vi­ron­ment for its staff all year.

Pfiz­er’s tri­al con­sist­ed of 2,260 ado­les­cents, and there were 18 cas­es of Covid-19 that ap­peared in the place­bo group, com­pared to none in the vac­ci­nat­ed group, the com­pa­ny said.

So far, there have been about 65 mil­lion dos­es of Covid-19 vac­cines that have been de­liv­ered but not ad­min­is­tered, the Times said. A lit­tle less than half — 31 mil­lion — of those are Pfiz­er-BioN­Tech’s vac­cine, which re­quires 2 dos­es per in­di­vid­ual to be ful­ly ef­fec­tive. — Josh Sul­li­van

Lil­ly do­nates 400,000 baric­i­tinib tablets to In­dia

Eli Lil­ly said Tues­day that it’s ini­tial­ly do­nat­ing 400,000 baric­i­tinib tablets to the In­di­an gov­ern­ment for el­i­gi­ble hos­pi­tal­ized Covid-19 pa­tients and the com­pa­ny said it will work ur­gent­ly to in­crease the quan­ti­ty of do­nat­ed prod­uct mul­ti­fold over the com­ing weeks.

The RA drug baric­i­tinib when com­bined with Gilead’s remde­sivir has an emer­gency use au­tho­riza­tion in the US to treat those hos­pi­tal­ized with Covid-19. Lil­ly said that on Mon­day it re­ceived per­mis­sion for re­strict­ed emer­gency use for baric­i­tinib (2 mg and 4 mg) in com­bi­na­tion with remde­sivir, for treat­ment of sus­pect­ed or lab­o­ra­to­ry con­firmed Covid-19 in hos­pi­tal­ized adults re­quir­ing sup­ple­men­tal oxy­gen, in­va­sive me­chan­i­cal ven­ti­la­tion, or ex­tra­cor­po­re­al mem­brane oxy­gena­tion. — Zachary Bren­nan

A law­suit in Rus­sia chal­lenges gov­ern­ment who tasked do­mes­tic com­pa­ny to make Gilead’s remde­sivir

Gilead has sued the Russ­ian gov­ern­ment for al­low­ing an­oth­er com­pa­ny to make its remde­sivir treat­ment for pa­tients with Covid-19, ac­cord­ing to fil­ings.

The fil­ing ac­cus­es The Phar­masyn­tez Com­pa­ny of us­ing Gilead’s process for man­u­fac­tur­ing remde­sivir with­out the con­sent of the patent hold­er.

Late in 2020, the gov­ern­ment is­sued a com­pul­so­ry li­cense to Phar­masyn­tez, who then ap­proached Gilead about po­ten­tial­ly man­u­fac­tur­ing a ver­sion of the med­i­cine, STAT re­port­ed. The com­pa­ny had plans to sell the drug at half the cost for na­tion­al se­cu­ri­ty’s sake.

Court ses­sion for the suit is sched­uled to be­gin on May 27.

The de­ci­sion comes with a de­bate over glob­al ac­cess to Covid-19 treat­ments and vac­cines for coun­tries in need. As the US has se­cured 1 bil­lion dos­es of the vac­cine, some ethi­cists have said that dos­es should be shared with oth­er coun­tries soon­er rather than lat­er. Bill Gates re­cent­ly re­ceived back­lash for say­ing in an in­ter­view that the US should keep vac­cine patents ex­clu­sive, cit­ing se­cu­ri­ty and cost is­sues. — Josh Sul­li­van

No­vavax will ex­pand Phase III tri­al to teenagers

Just hours be­fore it was re­port­ed that Pfiz­er/BioN­Tech’s Covid-19 vac­cine will be avail­able for ado­les­cents at the be­gin­ning of next week, No­vavax has an­nounced that it has ini­ti­at­ed the pe­di­atric ex­pan­sion of its Phase III clin­i­cal tri­al for its own vac­cine.

The tri­al will eval­u­ate 3,000 ado­les­cents be­tween the ages of 12 and 17 at 75 sites through­out the US, the com­pa­ny said in a state­ment. Par­tic­i­pants will ei­ther re­ceive the vac­cine or the place­bo in 2 dos­es 21 days apart from each oth­er, and they will be mon­i­tored for safe­ty up to 2 years af­ter the fi­nal dose.

The com­pa­ny’s jab has still not yet been ap­proved any­where in the world.

No­vavax an­nounced Mon­day that it will ship 200 mil­lion dos­es to the EU as a part of a draft sup­ply deal that was signed in De­cem­ber, de­spite the fact that the mak­er has been plagued with pro­duc­tion prob­lems. In a con­ver­sa­tion with End­points’ Ja­son Mast, No­vavax said it has worked to over­come sup­ply-chain chal­lenges, in­clud­ing for ma­te­ri­als as di­verse as Chilean tree bark and biore­ac­tor bags. — Josh Sul­li­van

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

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.