Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A fed­er­al com­mit­tee that ad­vis­es the CDC was ex­pect­ed to hold a vote Tues­day on a plan re­gard­ing the dis­tri­b­u­tion for ini­tial dos­es of ap­proved Covid-19 vac­cines. But that vote has been scrapped.

The Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, or ACIP, won’t be vot­ing un­til the com­mit­tee mem­bers learn more about which vac­cines be­come avail­able first, the Wall Street Jour­nal re­port­ed. The vote could po­ten­tial­ly wait un­til a spe­cif­ic vac­cine is au­tho­rized be­fore rec­om­mend­ing how to dole out the first dos­es.

Usu­al pro­ce­dure dic­tates that the com­mit­tee vote on­ly af­ter vac­cine can­di­dates have been cleared by reg­u­la­tors. A CDC spokesper­son con­firmed to the Jour­nal that no vote was sched­uled de­spite pri­or­i­ti­za­tion for ear­ly dos­ing ap­pear­ing on the com­mit­tee’s agen­da on­line.

Like­ly can­di­dates for the first in­di­vid­u­als to re­ceive Covid-19 vac­cines are high-risk pop­u­la­tions, health­care work­ers and em­ploy­ees in in­dus­tries such as food and agri­cul­ture.

Any pri­or­i­ti­za­tion plan could as­sist states craft­ing their own dis­tri­b­u­tion pro­grams. Late last month, CDC di­rec­tor Robert Red­field wrote a let­ter to gov­er­nors telling states to be ready for po­ten­tial vac­cine dis­tri­b­u­tion by Nov. 1.

Dis­trib­u­tors are fac­ing sev­er­al chal­lenges, not on­ly re­gard­ing the ac­tu­al hand­ing out of vac­cines but find­ing prop­er stor­age fa­cil­i­ties. Some mR­NA can­di­dates, like the ones be­ing de­vel­oped by Mod­er­na and Pfiz­er, must be stored at tem­per­a­tures well be­low freez­ing — po­ten­tial­ly at mi­nus-80 de­grees Cel­sius.

Eu­rope to re­port­ed­ly pro­vide some li­a­bil­i­ty shields to drug­mak­ers

Af­ter seek­ing pro­tec­tion from li­a­bil­i­ty in Eu­rope while pro­duc­ing Covid-19 vac­cine can­di­dates, sev­er­al big drug­mak­ers will now re­port­ed­ly be com­pen­sat­ed should their vac­cines cause un­ex­pect­ed side ef­fects.

The Eu­ro­pean Com­mis­sion is pro­vid­ing con­fi­den­tial li­a­bil­i­ty claus­es in its con­tracts with phar­ma com­pa­nies, Reuters re­port­ed Tues­day morn­ing, and has al­ready in­clud­ed such pro­vi­sions in deals with As­traZeneca and Sanofi. The bloc is still ne­go­ti­at­ing sim­i­lar con­di­tions with oth­er vac­cine mak­ers for ad­vance pur­chase of their vac­cine can­di­dates.

A spokesper­son for the com­mis­sion told the wire ser­vice that ad­vance pur­chase deals “pro­vide for Mem­ber States to in­dem­ni­fy the man­u­fac­tur­er for cer­tain li­a­bil­i­ties in­curred un­der spe­cif­ic and strict con­di­tions,” but “li­a­bil­i­ty still re­mains with the com­pa­nies.”

Vac­cine pro­duc­ers have been push­ing the EU to pro­vide full li­a­bil­i­ty pro­tec­tion, some­thing the union has been re­luc­tant to do. Last month, the Eu­ro­pean phar­ma in­dus­try’s vac­cines lob­by, Vac­cines Eu­rope, cir­cu­lat­ed a memo among its mem­bers cit­ing the “in­evitable” risks that come with ac­cel­er­at­ed vac­cine de­vel­op­ment.

Al­so on Tues­day, the Russ­ian gov­ern­ment claimed it will be tak­ing on some of the li­a­bil­i­ty for its com­pa­nies’ vac­cine can­di­dates it­self rather than re­quir­ing buy­ers to take on the full risk, per a sep­a­rate Reuters re­port. That ap­proach dif­fers from how the US is tack­ling things, as li­a­bil­i­ty has been shift­ed ful­ly to the gov­ern­ment.

Chi­na-backed Sino­vac starts PhI­II in Turkey

Sino­vac has start­ed a new Phase III tri­al for its Covid-19 vac­cine can­di­date in Turkey, the com­pa­ny an­nounced Tues­day.

The an­nounce­ment did not spec­i­fy ex­act­ly when the tri­al be­gan, on­ly that it has “re­cent­ly com­menced” eval­u­at­ing whether the Chi­nese com­pa­ny’s Coro­n­aVac prod­uct is safe and ef­fec­tive. Sino­vac’s tri­al will be ran­dom­ized, dou­ble-blind­ed and place­bo-con­trolled, seek­ing to en­roll 1,300 health­care work­ers and 12,000 mem­bers of the gen­er­al Turk­ish pop­u­la­tion.

In the com­pa­ny’s Phase I/II tri­als that were con­duct­ed in Chi­na ear­li­er this year, the vac­cine can­di­date showed im­mune re­spons­es in more than 90% of its 600 vol­un­teers, Sino­vac said.

Back in Ju­ly, the Chi­nese gov­ern­ment ap­proved Coro­n­aVac for emer­gency use, giv­ing dos­es to some med­ical pro­fes­sion­als and bor­der of­fi­cers. That in­for­ma­tion didn’t be­come pub­lic, how­ev­er, un­til late Au­gust, when a gov­ern­ment health of­fi­cial dis­closed the au­tho­riza­tion in an in­ter­view with state-owned me­dia. Reuters lat­er con­firmed that one of the prod­ucts men­tioned in the in­ter­view was Sino­vac’s can­di­date.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.