Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er, BioN­Tech say vac­cine is 95% ef­fec­tive, EUA sub­mis­sion 'with­in days'

Pfiz­er and BioN­Tech have done the fi­nal ef­fi­ca­cy analy­sis for their Phase III Covid-19 tri­al, and the re­sults con­firm the head­line-grab­bing re­lease from last week: Their vac­cine is 95% ef­fec­tive at pre­vent­ing Covid-19.

They al­so said the vac­cine was 94.5% ef­fec­tive in old­er adults, mit­i­gat­ing con­cerns that the first Covid-19 vac­cines might not work as well in one of the pop­u­la­tions most sus­cep­ti­ble to se­vere dis­ease.

The two com­pa­nies said they have al­so crossed the FDA’s key safe­ty thresh­old of two-months fol­low-up and will sub­mit for an emer­gency use au­tho­riza­tion “with­in days.” Al­though the agency will con­vene an ad­vi­so­ry com­mit­tee be­fore mak­ing a de­ci­sion, the an­nounce­ment like­ly sets up the Big Phar­ma and their biotech part­ner to ob­tain the first FDA OK for a Covid-19 vac­cine.

Pfiz­er CEO Al­bert Bourla said at dif­fer­ent con­fer­ences yes­ter­day af­ter­noon that they had passed the safe­ty thresh­old and would soon sub­mit to reg­u­la­tors. The com­pa­nies an­nounced last week that their vac­cine was “over 90% ef­fec­tive” in an in­ter­im analy­sis.

Mod­er­na, which an­nounced Mon­day that their vac­cine was 94.5% ef­fec­tive at an in­ter­im analy­sis, is al­so ex­pect­ed to re­lease fi­nal ef­fi­ca­cy da­ta and head to reg­u­la­tors soon. CEO Stéphane Ban­cel pre­dict­ed the first ad­vi­so­ry com­mit­tee hear­ings for any vac­cine to come Dec. 7th or Dec. 14th. The two vac­cines both use mR­NA and are high­ly sim­i­lar.

To­day’s ef­fi­ca­cy da­ta came from an analy­sis of 170 Covid-19 cas­es in their 44,000-per­son tri­al — 162 cas­es in the place­bo group and 8 cas­es in the vac­cine group. It al­so in­clud­ed Pfiz­er’s first safe­ty re­sults; the most se­vere side ef­fects were fa­tigue, which oc­curred in 3.8% of re­cip­i­ents, and headache, which oc­curred in 2% of re­cip­i­ents.

Pfiz­er said they saw 9 cas­es of se­vere dis­ease in the place­bo group and 1 in the vac­cine group, in­di­cat­ing the vac­cine can help pre­vent hos­pi­tal­iza­tion and death. Mod­er­na’s first analy­sis had shown 11 se­vere cas­es on place­bo and 0 in the vac­cine group.

Key ques­tions, how­ev­er, still re­main on how durable the vac­cine will be.

Al­though oth­er ques­tions re­main about how ef­fec­tive­ly Pfiz­er will be able to dis­trib­ute its vac­cine, which re­quires stor­age at -70 de­grees Cel­sius (-94 Fahren­heit), Bourla ex­pressed con­fi­dence yes­ter­day that roll­out would go far more smooth­ly than out­side ex­perts have feared.

The com­pa­ny has in­vest­ed in freez­er box­es to ship and store their vac­cines on dry ice. State health of­fi­cials have raised con­cerns about how well these will work for get­ting the vac­cine to rur­al ar­eas. Mod­er­na has less strin­gent cold-chain re­quire­ments.

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

Cap­ping Pas­cal So­ri­ot’s big turn­around, the an­a­lysts at Cowen say As­traZeneca is poised for a stel­lar year

Big Pharmas typically don’t get a lot of respect for R&D efforts. Their ROI is bad on a massive annual bill, there’s too much late-stage failure, analysts fret about the endurance of big franchises and the impact of generic competition.

Even as Pascal Soriot is staunching the bleeding around a badly handled Phase III readout for their Covid-19 vaccine, though, the AstraZeneca CEO is taking a bow today as Cowen lavishes praise on the pipeline and near-term prospects for the multinational — for the second year in a row.

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Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (Getty)

As­traZeneca CEO So­ri­ot plans new study to test that con­tro­ver­sial 90% ef­fi­ca­cy fig­ure, wait­ing for US da­ta be­fore go­ing to FDA

Pascal Soriot spent the long Thanksgiving weekend digging AstraZeneca out of a hole, promising to put an end to the questions around its interim Phase III vaccine data by conducting a new study while going to regulators with a large part of what it already has.

AstraZeneca and its partners at Oxford had initially touted high-level results from two studies conducted in the UK and Brazil as positive. But the enthusiasm was soon shadowed by confusion as observers probed into how the highest, 90% efficacy was seen in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort given the intended shots, the vaccine was only 62% effective, a rate that would’ve been respectable had Pfizer/BioNTech and Moderna not posted efficacy rates of 94%, 95% for their mRNA candidates. And many weren’t sure what to make of the average 70% number that AstraZeneca ran in headlines.

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Sev­er­al weeks af­ter get­ting hit with an RTF, Y-mAbs lands ap­proval for its oth­er neu­rob­las­toma can­di­date

Nearly two months after handing Y-mAbs a refusal to file letter for one of its main neuroblastoma candidates, the FDA gave the biotech an accelerated OK for the other — but with a box warning.

Y-mAbs, which flew mostly under the radar until a few years ago, snagged approval for naxitamab-gqgk as a second-line treatment in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Patients older than 1 year old can take the drug for relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. The good news cushioned last month’s blow, sending the company’s stock $YMAB — which sank more than 18% upon news of the RTF — up 10.15% as of Monday morning.

Stephané Bancel (Endpoints at JPM20)

Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

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Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A little over a year after completing successful pivotal trials, Rhythm Pharmaceuticals $RYTM has its first drug approval on its hands.

The Boston-based biotech announced Friday that the FDA gave setmelanotide the thumbs-up for three rare genetic disorders that result in obesity in patients six and older. It’s the agency’s first such approval, Rhythm said, with the indicated deficiencies being the POMC, PCSK1 and LEPR genes. Rhythm will market the drug as Imcivree, and plans to have it on the shelves in the first quarter of 2021.

Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

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

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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