Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Pfiz­er, BioN­Tech say Covid-19 vac­cine is more than 90% ef­fec­tive, ex­ceed­ing ex­pert ex­pec­ta­tions and set­ting up an EUA sub­mis­sion late this month

For 10 months, the US and the world have won­dered and watched and wait­ed for when an ef­fec­tive Covid-19 vac­cine will ar­rive. Pfiz­er said Mon­day morn­ing that it has.

The Big Phar­ma and its part­ner BioN­Tech said that, on an in­ter­im look, their vac­cine was at least 90% ef­fec­tive in pre­vent­ing symp­to­matic Covid-19 cas­es. If the da­ta hold up, it would mean a pan­dem­ic in­oc­u­la­tion vast­ly more ef­fec­tive than an­tic­i­pat­ed through­out 2020, when ex­perts warned that the first vac­cines could be as low as 60% or 70% ef­fec­tive and the FDA in­di­cat­ed it was will­ing to ap­prove jabs that sur­passed the 50% mark.

Pfiz­er said it will sub­mit for an emer­gency use au­tho­riza­tion around the third week of No­vem­ber, when it sur­pass­es a safe­ty bench­mark set by the FDA. FDA of­fi­cials have in­di­cat­ed they could move to en­act an EUA at record speed, al­though not be­fore con­ven­ing an ad­vi­so­ry com­mit­tee to re­view Pfiz­er’s da­ta.

A da­ta safe­ty and mon­i­tor­ing com­mit­tee didn’t flag any ma­jor safe­ty is­sues, al­though the com­pa­ny still has to reach the me­di­an two months of fol­lowup the FDA has re­quired Covid-19 vac­cine mak­ers reach in their Phase III tri­als.

A sea of ques­tions still looms for the mR­NA can­di­date, though. It’s not clear how well the vac­cine pre­vents in­fec­tion or se­vere cas­es of Covid-19 — an is­sue raised at the re­cent FDA ad­vi­so­ry com­mit­tee on vac­cines — and no one knows how long pro­tec­tion will last. The da­ta have al­so not been peer-re­viewed, draw­ing crit­i­cism from ac­tivists who have called for com­pa­nies not to re­lease Covid-19 re­sults by press re­lease.

Pub­lic Cit­i­zen, the left-lean­ing Wash­ing­ton-based NGO, called it “bad sci­ence,” not­ing the lin­ger­ing un­knowns on safe­ty and se­vere cas­es.

“Cru­cial in­for­ma­tion ab­sent from the com­pa­nies’ an­nounce­ment is any ev­i­dence that the vac­cine pre­vents se­ri­ous COVID-19 cas­es or re­duces hos­pi­tal­iza­tions and deaths due to the dis­ease,” Michael Car­ome, the NGO’s lead health re­searcher, said in a state­ment. “More im­por­tant­ly, crit­i­cal safe­ty da­ta from the phase 3 tri­al of the Pfiz­er and BioN­Tech vac­cine is not yet avail­able.”

Still, the re­sults pro­vide a ma­jor boon for hopes that vac­cines can even­tu­al­ly help curb the pan­dem­ic in the US and world­wide. Mod­er­na, the vac­cine de­vel­op­er like­ly to read­out next, al­so us­es mR­NA, a tech­nol­o­gy that had nev­er been test­ed in large scale tri­als be­fore 2020, and vir­tu­al­ly all ma­jor can­di­dates tar­get the coro­n­avirus spike pro­tein that Pfiz­er tar­gets.

Even if the vac­cine holds up and is au­tho­rized by the FDA, though, it will still be in short sup­ply. Pfiz­er has said that around 50 mil­lion dos­es of the vac­cine could be avail­able by the end of the year, with 1 bil­lion dos­es avail­able in 2021. The vac­cine re­quires two dos­es to be ef­fec­tive.

The 90% fig­ure comes from an analy­sis of 94 con­firmed cas­es of Covid-19 across both arms of the com­pa­ny’s Phase III tri­al, which has en­rolled 44,000 vol­un­teers to date. The com­pa­ny had orig­i­nal­ly planned to con­duct its first analy­sis at 32 cas­es, prompt­ing CEO Al­bert Bourla to in­sist they’d know if it worked by Oc­to­ber, but af­ter dis­cus­sions with the FDA, agreed to look af­ter 62 cas­es. By that time, though, 94 cas­es had al­ready ac­crued.

In a state­ment, Bourla cast the re­sults as a ma­jor mile­stone in the fight against the pan­dem­ic, not­ing that it comes at a time when cas­es are surg­ing to record lev­els. Those surg­ing cas­es like­ly helped Pfiz­er reach the ef­fi­ca­cy da­ta faster than they would have if the virus was un­der con­trol.

“To­day is a great day for sci­ence and hu­man­i­ty,” he said. “The first set of re­sults from our Phase 3 COVID-19 vac­cine tri­al pro­vides the ini­tial ev­i­dence of our vac­cine’s abil­i­ty to pre­vent COVID-19. We are reach­ing this crit­i­cal mile­stone in our vac­cine de­vel­op­ment pro­gram at a time when the world needs it most with in­fec­tion rates set­ting new records, hos­pi­tals near­ing over-ca­pac­i­ty and economies strug­gling to re­open.”

Al­though Pfiz­er has in­di­cat­ed they would want to un­blind the study once re­sults were in, the com­pa­ny said that it will con­tin­ue un­til it reach­es 164 con­firmed cas­es. At that point, how­ev­er, it’s un­clear whether the FDA would want them to con­tin­ue the blind­ed study, which would al­low them to col­lect bet­ter long term safe­ty da­ta.

The an­nounce­ment marks a ma­jor suc­cess for Bourla, who was pro­mot­ed to CEO two years ago to re-en­er­gize a slow-foot­ed Amer­i­can gi­ant and who ar­guably bet more on his com­pa­ny’s Covid-19 vac­cine ef­forts than any oth­er ex­ec­u­tive on the plan­et. Team­ing with the Ger­man mR­NA biotech BioN­Tech, he es­chewed gov­ern­ment fund­ing on the prin­ci­ple that they could move faster alone. Asked by Time in Ju­ly what would hap­pen if the FDA re­ject­ed the vac­cine they in­vest­ed over a $1 bil­lion in, he said: “We will just have to write it off and call it a day.”

Pfiz­er, a com­pa­ny that first made its mark mass-pro­duc­ing peni­cillin dur­ing World War II, could now stand to reap both the pres­tige and fi­nan­cial wind­fall of the first ef­fec­tive Covid-19 shot. The gov­ern­ment has agreed to pay the New York phar­ma $1.95 bil­lion for 100 mil­lion dos­es of its vac­cine. Pro­jec­tions for fu­ture sales vary great­ly, but SVB Leerink  pegged them for over $3 bil­lion in 2021 and JP Mor­gan has put that fig­ure as high as $5.5 bil­lion.

With the world like­ly fac­ing a short­age of coro­n­avirus vac­cines for sev­er­al years to come and vac­ci­nat­ed peo­ple like­ly to need boost­er shots, the prod­uct could be a block­buster for a con­sid­er­able time.

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

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Covid-19 roundup: US se­cures 100,000 dos­es of Eli Lil­ly's an­ti­body cock­tail; Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta

A couple weeks after racking up its third EUA for a Covid-19 treatment — this one for its antibody cocktail — Eli Lilly has struck a deal with the US government for at least 100,000 doses.

The US will pay $210 million for doses of bamlanivimab and etesevimab, which will be delivered through March 31, Lilly said in a statement. The deal builds on 1.45 million doses of bamlanivimab alone that the US has already purchased, more than 1 million of which have been delivered. Another 450,000 doses of the single antibody are also expected to arrive by March 31.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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