Stephen Hahn, FDA commissioner (AP Images)

Covid-19 roundup: FDA seeks vac­cine ad­comm meet­ings on Dec. 8-10 — re­port; Hahn to make all EUA da­ta pub­lic

With Pfiz­er re­leas­ing its com­plet­ed Phase III ef­fi­ca­cy and safe­ty da­ta Wednes­day morn­ing, the FDA is re­port­ed­ly ask­ing its ad­comm to set aside dates in ear­ly De­cem­ber to dis­cuss Covid-19 vac­cines.

The ad­comm will like­ly con­vene on Dec. 8, 9 and 10 to go over not on­ly Pfiz­er’s vac­cine can­di­date, but al­so Mod­er­na’s, ac­cord­ing to a CN­BC re­port. The plans are not yet fi­nal­ized, per two sources quot­ed in the sto­ry.

Pfiz­er said in a press re­lease Wednes­day morn­ing that the com­pa­ny and its part­ner BioN­Tech have reached the num­ber of con­firmed Covid-19 cas­es to com­plete its late-stage tri­al. Ini­tial da­ta show the vac­cine 95% ef­fec­tive at pre­vent­ing Covid-19, and 94.5% ef­fec­tive in old­er adults.

The pair have al­so crossed the FDA’s key safe­ty thresh­old of two-months fol­low-up and will sub­mit for an emer­gency use au­tho­riza­tion “with­in days,” they said.

Mod­er­na, which like Pfiz­er is us­ing mR­NA tech­nol­o­gy to de­vel­op its vac­cine, an­nounced Mon­day the in­ter­im re­sults from its Phase III study, say­ing their can­di­date was 94.5% ef­fec­tive. The com­pa­ny is al­so ex­pect­ed to re­lease fi­nal da­ta soon and sub­mit its own EUA short­ly there­after. — Max Gel­man

Amid pres­sure, FDA promis­es to make all da­ta for EUAs pub­lic

In an ef­fort to shore up pub­lic con­fi­dence, FDA chief Stephen Hahn said in a state­ment Tues­day that the agency will be mak­ing pub­lic all da­ta and in­for­ma­tion re­lat­ed to emer­gency use au­tho­riza­tions for Covid-19 vac­cines and drugs.

The move comes af­ter polls have shown grow­ing wor­ry among Amer­i­cans that pol­i­tics has been put be­fore sci­ence and that ear­ly vac­cines may not see full adop­tion due to con­cerns they’ve been rushed. In or­der to coun­ter­act this, Hahn said reg­u­la­tors have al­ready tak­en sev­er­al steps, in­clud­ing host­ing a vac­cine ad­comm and cre­at­ing ed­u­ca­tion­al ma­te­ri­als to ex­plain the steps of the drug and vac­cine de­vel­op­ment process­es.

Tues­day’s move just marks an­oth­er step in re­as­sur­ing the pub­lic, Hahn said.

“Let me be clear on a cru­cial point — the is­suance of an EUA is based on da­ta and sci­ence,” Hahn said. “For an EUA to be au­tho­rized, FDA’s ca­reer sci­en­tists con­duct a rig­or­ous eval­u­a­tion of cur­rent­ly avail­able sci­en­tif­ic ev­i­dence about a med­ical prod­uct.”

Hahn added that should new da­ta come about, the agency can adapt or re­voke an EUA, which it has done pre­vi­ous­ly dur­ing the pan­dem­ic.

Lead­ing up to this month’s elec­tion, pub­lic health of­fi­cials had faced pres­sure from Pres­i­dent Don­ald Trump, who made get­ting a vac­cine out be­fore No­vem­ber as one of his key cam­paign promis­es. That didn’t hap­pen, how­ev­er, with Pfiz­er and Mod­er­na both re­leas­ing the first ef­fi­ca­cy da­ta for their Phase III vac­cine stud­ies af­ter the elec­tion was called for Joe Biden.

The Trump ad­min­is­tra­tion has tak­en oth­er steps to pres­sure the FDA, with HHS Sec­re­tary Alex Azar open­ly plot­ting Hahn’s ouster at one point, and bris­tled af­ter Hahn tough­ened vac­cine re­quire­ments in late Sep­tem­ber. Pfiz­er had orig­i­nal­ly aimed for just 32 con­firmed cas­es in its first analy­sis, prompt­ing CEO Al­bert Bourla to say the com­pa­ny would know if it worked by Oc­to­ber. But af­ter speak­ing with reg­u­la­tors, they bumped that up to 62. Ul­ti­mate­ly, they reg­is­tered 94 cas­es. — Max Gel­man

Study says Sino­vac vac­cine in­duces quick im­mune re­sponse, but low­er an­ti­body count

Chi­nese biotech Sino­vac pub­lished peer-re­viewed re­sults for its Covid-19 vac­cine can­di­date Coro­n­aVac on Wednes­day, with da­ta show­ing the vac­cine trig­gered a quick im­mune re­sponse in pa­tients.

But the same da­ta al­so il­lus­trat­ed that the lev­el of an­ti­bod­ies pro­duced was low­er than in those who had re­cov­ered from the dis­ease. The re­sults, com­ing from Sino­vac’s Phase I/II tri­al en­rolling more than 700 in­di­vid­u­als, were pub­lished in full in The Lancet. 

“In sum­ma­ry, Coro­n­aVac was well tol­er­at­ed and in­duced hu­moral re­spons­es against SARS-CoV-2, which sup­port­ed the ap­proval of emer­gency use of Coro­n­aVac in Chi­na and in three phase 3 stud­ies,” the au­thors of the pa­per wrote. “The pro­tec­tive ef­fi­ca­cy of Coro­n­aVac re­mains to be de­ter­mined.”

Wednes­day’s pa­per comes af­ter the com­pa­ny re­leased topline Phase I/II re­sults in June, which said the vac­cine safe­ly pro­duced an­ti­bod­ies in more than 90% of vol­un­teers. The vac­cine has been de­scribed as old school, us­ing a chem­i­cal­ly in­ac­ti­vat­ed virus in the hopes of cre­at­ing a pro­tec­tive an­ti­body re­sponse.

Sino­vac is one of two Chi­nese com­pa­nies, along with Sinopharm, test­ing a Covid-19 vac­cine in Phase III stud­ies. Cur­rent­ly, Sino­vac is con­duct­ing mul­ti­ple Phase III tri­als in Brazil, In­done­sia and Turkey, and its vac­cine was one of the can­di­dates au­tho­rized by the Chi­nese gov­ern­ment in Ju­ly to be ad­min­is­tered to some med­ical pro­fes­sion­als and bor­der of­fi­cers.

Last week, Brazil halt­ed its Phase III Sino­vac tri­al af­ter the death of a tri­al par­tic­i­pant, but the hold was lift­ed af­ter it was de­ter­mined the in­di­vid­ual died by sui­cide.

Sino­vac is cur­rent­ly 5th in End­points News’ Covid-19 vac­cine race track­er. — Max Gel­man

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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

Covid-19 roundup: Rus­sia prices vac­cine 't­wo or more times cheap­er' than mR­NA shots; Sino­vac PhI­II da­ta ex­pect­ed in ear­ly De­cem­ber

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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