FDA au­tho­rizes Pfiz­er-BioN­Tech Covid-19 vac­cine

The first Covid-19 vac­cine has ar­rived in Amer­i­ca.

The FDA is­sued an emer­gency use au­tho­riza­tion for the Pfiz­er-BioN­Tech vac­cine late Fri­day, mark­ing a his­toric turn­ing point in the fight against a dead­ly pan­dem­ic, but that one will still leave a long road ahead as the Big Phar­ma and fed­er­al of­fi­cials try to scale up and roll out lim­it­ed dos­es while the virus con­tin­ues to rav­age the US.

The EUA comes 24 hours af­ter a com­mit­tee of out­side ex­perts vot­ed 17-4 to rec­om­mend the agency au­tho­rize the vac­cine. In a 44,000-per­son Phase III tri­al, the vac­cine was 95% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 and did not trig­ger se­ri­ous ad­verse events, al­though it did in­duce mild symp­toms such as headache and fa­tigue. The da­ta was pub­licly re­viewed by the FDA and pub­lished in The New Eng­land Jour­nal of Med­i­cine.

It is the fastest a vac­cine has ever been de­vel­oped, com­ing less than a year af­ter the nov­el coro­n­avirus broke out in Chi­na. It is al­so the first mR­NA vac­cine to ever be li­censed, po­ten­tial­ly herald­ing a new era in how vac­cines are made for a mul­ti­tude of in­fec­tions.

Al­though now au­tho­rized, a vac­cine will re­main out of reach for the vast ma­jor­i­ty of Amer­i­cans. Op­er­a­tion Warp Speed of­fi­cials have re­peat­ed­ly said they ex­pect to dis­trib­ute 20 mil­lion dos­es of the vac­cine un­til, with those first dos­es like­ly re­served for health­care work­ers and the el­der­ly. But some hos­pi­tals and out­side ex­perts have warned that such roll­outs may not be smooth, as cash-strapped states will strug­gle to get dos­es in arms and com­pa­nies may en­counter man­u­fac­tur­ing de­lays.

Still, the EUA marks a piv­otal mo­ment for a coun­try and a fed­er­al gov­ern­ment that, hav­ing failed to scale up test­ing, adopt uni­ver­sal mask-wear­ing, or fol­low oth­er re­peat­ed pub­lic health guid­ance, has come to re­ly on the ad­vent of wide­ly avail­able in­oc­u­la­tions to curb what has be­come a dai­ly of on­slaught of death.

Since the elec­tion, Pres­i­dent Trump has made scant men­tion of the dai­ly toll the pan­dem­ic is now tak­ing on the US, with up to 3,000 Amer­i­cans now dy­ing of the virus per day. But he has sought to take cred­it for the Pfiz­er-BioN­Tech vac­cine, pub­licly feud­ing with the Big Phar­ma over whether or not they were in­volved in Op­er­a­tion Warp Speed and hold­ing a “Vac­cine Sum­mit” at the White House to take cred­it for has­ten­ing de­vel­op­ment.

The FDA’s de­ci­sion Fri­day came af­ter the pres­i­dent threat­ened to fire Com­mis­sion­er Stephen Hahn if the agency did not is­sue an EUA by the end of the day.

The FDA had al­ready re­leased a state­ment say­ing they told Pfiz­er they were fi­nal­iz­ing the au­tho­riza­tion. And HHS sec­re­tary  Alex Azar had al­ready ap­peared on Good Morn­ing Amer­i­ca to an­nounce that dos­es would ar­rive in Amer­i­can arms by Mon­day or Tues­day, telling George Stephanopou­los that the agency still need­ed time to ham­mer out in­for­ma­tion for doc­tors.

It is not clear whether the ac­cel­er­at­ed de­ci­sion will re­sult in Amer­i­cans be­ing in­oc­u­lat­ed any faster.

Over the sum­mer, the US signed a pur­chase or­der for 100 mil­lion Pfiz­er vac­cines and have an op­tion to or­der 500 mil­lion more, but they may find it to dif­fi­cult to ac­quire any of those ad­di­tion­al dos­es be­fore the sum­mer. For­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber Scott Got­tlieb told CN­BC this month that the gov­ern­ment turned down an of­fer from Pfiz­er to buy more dos­es af­ter their ini­tial ef­fi­ca­cy da­ta came out. (Azar de­nied the ac­count, say­ing Pfiz­er nev­er said how many ex­tra dos­es they could of­fer).

The EUA is like­ly to be fol­lowed by a sec­ond EUA for the Mod­er­na vac­cine, which showed 94.5% ef­fi­ca­cy in its own Phase III tri­al. An FDA ad­vi­so­ry com­mit­tee hear­ing is sched­uled for Thurs­day. J&J is al­so ex­pect­ed to read out on their vac­cine in Jan­u­ary, with the As­traZeneca shot be­hind them.

It is pos­si­ble that Mod­er­na’s mR­NA shot be­comes the dom­i­nant vac­cine in the US. HHS ex­er­cised an op­tion to pur­chase an ad­di­tion­al 100 mil­lion dos­es of the vac­cine to­day, giv­ing the US enough Mod­er­na and BioN­Tech shots to vac­ci­nate 150 mil­lion Amer­i­cans by June.

The EUA is al­so a turn­ing point for BioN­Tech, a Ger­man mR­NA biotech run by a hus­band-and-wife sci­en­tists who long op­er­at­ed with less flash and less ven­ture cap­i­tal than their mR­NA ri­vals in Cam­bridge. The com­pa­ny ap­proached their pan­dem­ic ef­fort with sim­i­lar in­con­spic­u­ous­ness, dis­clos­ing the pro­gram in a sin­gle line in the mid­dle of an SEC doc­u­ment in Feb­ru­ary. They now stand as one of the most fa­mous biotechs in the world.

It is al­so a win for Pfiz­er and CEO Al­bert Bourla, who bet big on BioN­Tech’s tech­nol­o­gy and chose to go alone, re­ject­ing gov­ern­ment funds and ul­ti­mate­ly suc­cess­ful­ly de­vel­op­ing the first proven Covid-19 vac­cine. And it marks the cul­mi­na­tion of decades of work from aca­d­e­mics who worked to tame a mol­e­cule that much of the in­dus­try didn’t want to touch but which they saw as the fu­ture of vac­cines and drug de­vel­op­ment. That in­cludes Katal­in Karikó and Drew Weiss­man at the Uni­ver­si­ty Penn­syl­va­nia, who li­censed their tech to Mod­er­na and BioN­Tech and who now work for the lat­ter.

The UK and Cana­da au­tho­rized the vac­cine ear­li­er this week.

Even though its now au­tho­rized, stud­ies on the vac­cine will con­tin­ue, as Pfiz­er con­tin­ues to mon­i­tor vol­un­teers in its tri­al and the CDC and oth­er branch­es of the fed­er­al gov­ern­ment roll out plans to mon­i­tor vac­cine re­cip­i­ents across the coun­try.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Rep. Buddy Carter (R-GA) (Bill Clark/CQ Roll Call via AP Images).

US House as­sem­bles bi­par­ti­san cau­cus on do­mes­tic phar­ma man­u­fac­tur­ing

The US House of Representatives is taking a further interest in domestic pharma manufacturing by creating the Domestic Pharmaceutical Manufacturing Caucus, led by Reps. Buddy Carter (R-GA), Elissa Slotkin (D-MI), Gus Bilirakis (R-FL) and Chrissy Houlahan (D-PA).

As the supply chain increasingly is outsourced to China and India, particularly on the active pharmaceutical ingredient side, the caucus will aim to focus on moving forward legislation that incentivizes greater domestic manufacturing of medicines. Carter said the caucus will try to reduce US reliance on “foreign adversaries,” try to ensure an adeqate supply of pharmaceuticals and try to halt supply chain disruptions.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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