Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

Af­ter a two-month hold on mil­lions of dos­es of the J&J vac­cine, the FDA will an­nounce that it is re­leas­ing 10 mil­lion dos­es and trash­ing 60 mil­lion that were made at a trou­bled Bal­ti­more plant, The New York Times scooped on Fri­day morn­ing.

Emer­gent BioSo­lu­tions re­port­ed that the dos­es were con­t­a­m­i­nat­ed af­ter drug ma­te­r­i­al in­tend­ed for the As­traZeneca vac­cine came in close con­tact with me­dia pre­pared for a J&J run. As a re­sult, the dos­es were held from dis­tri­b­u­tion, caus­ing a shake­up in ear­ly avail­abil­i­ty.

Lat­er, a Form 483 from the FDA re­vealed im­prop­er de­con­t­a­m­i­na­tion meth­ods from staff and oth­er un­san­i­tary con­di­tions like paint chip­ping on the walls and mold grow­ing in the build­ing.

An­oth­er 60 mil­lion dos­es of As­traZeneca’s could be­come avail­able as well. The FDA has not de­ter­mined whether Emer­gent can re­sume pro­duc­tion again, sev­er­al out­lets re­port­ed. — Josh Sul­li­van

EMA up­dates As­traZeneca vac­cine warn­ings, con­tin­ues re­view of my­ocardi­tis and peri­cardi­tis for mR­NA vac­cines

The Eu­ro­pean Med­i­cines Agency said Fri­day that it has con­clud­ed that peo­ple who have pre­vi­ous­ly had cap­il­lary leak syn­drome must not be vac­ci­nat­ed with As­traZeneca’s Covid vac­cine Vaxzevria.

“The Com­mit­tee car­ried out an in-depth re­view of 6 cas­es of cap­il­lary leak syn­drome in peo­ple who had re­ceived Vaxzevria. Most of the cas­es oc­curred in women and with­in 4 days of vac­ci­na­tion. Three of those af­fect­ed had a his­to­ry of cap­il­lary leak syn­drome and one of them sub­se­quent­ly died. As of 27 May 2021, more than 78 mil­lion dos­es of Vaxzevria had been ad­min­is­tered in the EU/EEA and the UK,” EMA said.

The agency al­so said it’s con­tin­u­ing its re­view of my­ocardi­tis (in­flam­ma­tion of the heart mus­cle) and peri­cardi­tis (in­flam­ma­tion of the mem­brane around the heart) in a small num­ber of peo­ple fol­low­ing vac­ci­na­tion with Covid vac­cines, in­clud­ing the one from Pfiz­er.

As of the end of May 2021, cas­es of my­ocardi­tis re­port­ed in the EEA from Eu­dravig­i­lance data­base were 122 (Pfiz­er’s Comir­naty), 16 (Mod­er­na’s vac­cine) and 38 (As­traZeneca’s Vaxzevria) and 0 for J&J. The ex­po­sure in the EEA for each vac­cine was around 160 mil­lion dos­es for Comir­naty, 19 mil­lion dos­es for Mod­er­na, 40 mil­lion for Vaxzevria and 2 mil­lion for Janssen.

And as of the end of May 2021, EMA said cas­es of peri­cardi­tis re­port­ed in the EEA data­base were 126 (Comir­naty), 18 (Mod­er­na), 47 (Vaxzevria) and 1 (Janssen).

“For Comir­naty and COVID-19 Vac­cine Mod­er­na the PRAC is re­view­ing cas­es of my­ocardi­tis and peri­cardi­tis in the con­text of a safe­ty sig­nal, un­der an ac­cel­er­at­ed timetable (fi­nal­i­sa­tion ex­pect­ed in Ju­ly),” EMA said.

The CDC on Thurs­day, at an FDA ad­vi­so­ry com­mit­tee meet­ing on vac­ci­nat­ing chil­dren, al­so pre­sent­ed its find­ings on my­ocardi­tis and peri­cardi­tis fol­low­ing mR­NA vac­ci­na­tion, not­ing 488 to­tal re­ports for the Pfiz­er-BioN­Tech vac­cine and 301 re­ports for Mod­er­na through the end of May. CDC found that of the re­ports, the me­di­an age af­ter the first dose was 30, and 24 for the sec­ond dose, with more males than fe­males re­port­ing my­ocardi­tis and peri­cardi­tis. CDC said 15 are still hos­pi­tal­ized and three are in the in­ten­sive care unit.

While the slides show no sta­tis­ti­cal sig­nal yet, CDC’s ACIP has sched­uled a meet­ing for next Fri­day to fur­ther up­date the da­ta, and dis­cuss its eval­u­a­tion of my­ocardi­tis fol­low­ing mR­NA vac­ci­na­tions, as well as to as­sess the ben­e­fit-risk bal­ance. — Zachary Bren­nan

Pfiz­er has emer­gency plan to pro­duce an­oth­er vac­cine in months, if need­ed

Dur­ing the G7 sum­mit Thurs­day, Pfiz­er CEO Al­bert Bourla an­nounced that if a new vac­cine were need­ed, the com­pa­ny has a process to en­sure it could be de­vel­oped with­in 100 days. He al­so re­in­forced that ac­cord­ing to his com­pa­ny’s da­ta, none of the ex­ist­ing vari­ant strains have es­caped pro­tec­tion from the vac­cine.

“I re­peat: none,” he said. “Not one.”

Pfiz­er sci­en­tists are al­so pur­su­ing an oral treat­ment against Covid-19, the ini­tial re­sults of which Bourla called “promis­ing.” If things go ac­cord­ing to plan, the com­pa­ny could ap­ply for ap­proval by the end of 2021.

The Group of Sev­en is ex­pect­ed to do­nate 1 bil­lion Covid-19 vac­cine dos­es to low-in­come coun­tries, British Prime Min­is­ter Boris John­son said Thurs­day.

The news came just a few hours af­ter Pres­i­dent Joe Biden an­nounced that the US was set to do­nate at least 500 mil­lion Pfiz­er-BioN­Tech shots, Reuters re­ports. The group is ex­pect­ed to agree to the do­na­tion dur­ing the three-day sum­mit at Car­bis Bay in Eng­land.

Eng­land is ex­pect­ed to do­nate 100 mil­lion of those shots, 80 mil­lion of which will go to CO­V­AX,  John­son has said.

Both coun­tries have rolled out suc­cess­ful vac­ci­na­tion cam­paigns. Near­ly 52% of the to­tal US pop­u­la­tion, and 61.5% of adults have re­ceived at least one dose of the vac­cine. In Eng­land, 77% of adults have re­ceived a jab.

But one bil­lion dos­es may not be enough. An­na Mar­riott, the glob­al pover­ty or­ga­ni­za­tion Ox­fam’s health pol­i­cy man­ag­er, said that if the best lead­ers can do is do­nate 1 bil­lion dos­es, the sum­mit will have been a fail­ure. Mar­riott called for 11 bil­lion dos­es to end the pan­dem­ic, and called for in­tel­lec­tu­al prop­er­ty waivers, Reuters re­port­ed. Near­ly 4 bil­lion peo­ple are de­pen­dent up­on vac­cines from CO­V­AX, the pro­gram from Gavi, the vac­cine al­liance to pro­vide shots to low- and mid­dle-in­come coun­tries.

The virus has led to the deaths of 3.9 mil­lion peo­ple since its start in Chi­na in 2019. — Josh Sul­li­van

Ger­many de­bates bail­ing on Cure­Vac as the wait con­tin­ues

Ger­man Health Min­is­ter Jens Spahn no longer plans to use Cure­Vac’s Covid-19 vac­cine for the cur­rent vac­ci­na­tion cam­paign, RP On­line has re­port­ed.

EMA ap­proval was orig­i­nal­ly ex­pect­ed by May, but on Tues­day news broke that reg­u­la­to­ry ap­proval of the vac­cine shouldn’t be ex­pect­ed to come be­fore Au­gust.

Chief pro­duc­tion of­fi­cer Flo­ri­an von der Mülbe has blamed de­lays on sup­ply chain is­sues. In Ju­ly 2020, GSK an­nounced it would in­vest $293 mil­lion in the jab and take on man­u­fac­tur­ing re­spon­si­bil­i­ties. — Josh Sul­li­van

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

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Covid-19 roundup: Re­al world da­ta sug­gest As­traZeneca vac­cine ef­fec­tive against Delta, Al­pha vari­ants; No­vavax hails pos­i­tive study on coro­n­avirus, flu shots com­bo

AstraZeneca’s Covid-19 vaccine, which has been authorized for use in the EU and Japan among many countries but not yet the US, has proved effective against the Delta variant, the company announced on Tuesday.

Real world data from Public Health England showed that the vaccine conferred high levels of protection against the variant that originated in India, as its 2 doses demonstrated 92% efficacy against hospitalization due to this variant. For the Alpha variant, which originated in the UK, the vaccine spurred a 86% reduction in hospitalization, with no deaths reported.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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