FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Fri­day re­leased about 10 mil­lion dos­es of J&J’s vac­cine for use, and dis­posed of an­oth­er 60 mil­lion dos­es that were man­u­fac­tured at the now-shut­tered Emer­gent BioSo­lu­tions fa­cil­i­ty in Bal­ti­more where cross-con­t­a­m­i­na­tion oc­curred.

The agency said it’s not yet ready to al­low the Emer­gent plant to be in­clud­ed in the J&J EUA, but that may oc­cur soon. FDA came to the de­ci­sion to au­tho­rize some of the dos­es af­ter re­view­ing fa­cil­i­ty records and qual­i­ty test­ing re­sults.

Pe­ter Marks, FDA

“This re­view has been tak­ing place while Emer­gent BioSo­lu­tions pre­pares to re­sume man­u­fac­tur­ing op­er­a­tions with cor­rec­tive ac­tions to en­sure com­pli­ance with the FDA’s cur­rent good man­u­fac­tur­ing prac­tice re­quire­ments,” said CBER di­rec­tor Pe­ter Marks.

Emer­gent pre­vi­ous­ly ru­ined 15 mil­lion dos­es of J&J’s Covid-19 vac­cine in March due to the cross-con­t­a­m­i­na­tion with the As­traZeneca vac­cine, which was pre­vi­ous­ly made at the same Bal­ti­more site. In April, Emer­gent slammed the brakes on all pro­duc­tion there, at the FDA’s be­hest, and J&J took con­trol of the plant.

Now, the 10 mil­lion dos­es that are OK to be used may al­so be ex­port­ed, but the FDA said Fri­day that will come with con­di­tions. For in­stance, for any ex­port of these two batch­es OKed for use, or of vac­cine man­u­fac­tured from these batch­es, J&J and Emer­gent agreed that the FDA may share rel­e­vant in­for­ma­tion, un­der an ap­pro­pri­ate con­fi­den­tial­i­ty agree­ment, with the reg­u­la­to­ry au­thor­i­ties of the coun­tries in which the vac­cine may be used.

Ad­di­tion­al batch­es are still un­der re­view, FDA said, but the agency de­clined to say how many or even how many dos­es are in one batch. The New York Times first re­port­ed on Fri­day that the FDA would not al­low the use of the 60 mil­lion dos­es. J&J did not re­spond to a re­quest for com­ment.

The Eu­ro­pean Med­i­cines Agency al­so re­leased a state­ment on Fri­day, say­ing that based on avail­able in­for­ma­tion, batch­es of the vac­cine re­leased in the EU are not af­fect­ed by the cross-con­t­a­m­i­na­tion that oc­curred at the Emer­gent fa­cil­i­ty.

“How­ev­er, as a pre­cau­tion and to safe­guard the qual­i­ty of vac­cines, the su­per­vi­so­ry au­thor­i­ties [the med­i­cines au­thor­i­ties in Bel­gium and the Nether­lands who are re­spon­si­ble for batch re­lease in the EU] have rec­om­mend­ed not re­leas­ing vac­cine batch­es con­tain­ing the ac­tive sub­stance made at around the same time that the con­t­a­m­i­na­tion oc­curred,” the EMA said.

Ad­di­tion­al­ly, the FDA has ex­tend­ed the ex­pi­ra­tion dat­ing for the re­frig­er­at­ed J&J dos­es, af­ter re­view­ing in­for­ma­tion and de­ter­min­ing that the vac­cine can be stored at 2-8 de­grees Cel­sius for 4.5 months, in­stead of 3 months.

More than 10 mil­lion peo­ple in the US have now re­ceived the J&J vac­cine, all of whom re­ceived vac­cines made at the com­pa­ny’s plant in the Nether­lands. An­oth­er 10 mil­lion more dos­es have been de­liv­ered across the coun­try but not ad­min­is­tered yet, ac­cord­ing to the CDC.

As of the end of May, 2 mil­lion dos­es of the J&J vac­cine have been ad­min­is­tered in the EU, EMA said.

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).

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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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.”

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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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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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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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantial reforms to the advisory committee process at the agency.

Short on examples of the adcomms she was referring to, Cavazzoni said at a BIO event aired on Monday that some recent committees show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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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.