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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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