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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Covid-19 roundup: As­pen to pro­duce gener­ic J&J vac­cine for Africa; First boost­ers for un­der-18-year-olds could come next week — re­port

After some ups and downs surrounding the manufacturing of J&J’s Covid-19 vaccine as the South African company’s site, Aspen Pharmacare has announced an agreement with the pharma to make and sell an Aspen-branded Covid-19 vaccine through the continent.

The agreement will expand the already-existing tech transfer and agreement to give Aspen the right to make vaccines from drug substance supplied by J&J, and sell the finished form under the name Aspenovax to public sector markets in Africa.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.