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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of face plants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.