Covid-19 roundup: EMA rec­om­mends Mod­er­na vac­cine for au­tho­riza­tion; Wood­cock re­turns to FDA as Hahn ad­vi­sor — re­ports

Af­ter de­lay­ing its de­ci­sion ear­li­er this week, the EMA an­nounced it has for­mal­ly rec­om­mend­ed au­tho­riz­ing Mod­er­na’s Covid-19 vac­cine.

Reg­u­la­tors came to the de­ci­sion Wednes­day morn­ing, mark­ing the sec­ond vac­cine giv­en au­tho­riza­tion in Eu­rope fol­low­ing Pfiz­er and BioN­Tech. EMA had pre­vi­ous­ly sched­uled a dead­line for Jan. 12 to reach a de­ci­sion.

The ball will now head to the Eu­ro­pean Com­mis­sion’s court, which has the fi­nal say on any opin­ions giv­en by the EMA and CHMP. Should the body give it the thumbs up — a vir­tu­al cer­tain­ty — the EU would be­come the fourth to OK the vac­cine, fol­low­ing au­tho­riza­tions in the US, Cana­da and Is­rael.

Wednes­day’s de­ci­sion comes about one week af­ter Mod­er­na locked down a deal with Swedish CD­MO Re­ci­pharm for work on an undis­closed por­tion of Mod­er­na’s vac­cine sup­ply out­side of the US.

Back in De­cem­ber, the Eu­ro­pean Com­mis­sion ex­er­cised an op­tion to pur­chase 80 mil­lion ad­di­tion­al dos­es of Mod­er­na’s shot, bring­ing its com­mit­ment to 160 mil­lion dos­es. — Max Gel­man

Wood­cock back at FDA as Hahn ad­vi­sor

For­mer CDER di­rec­tor Janet Wood­cock is re­port­ed­ly back at the FDA af­ter step­ping aside to join Op­er­a­tion Warp Speed.

Janet Wood­cock

Wood­cock has joined the agency as prin­ci­pal med­ical ad­vi­sor to FDA com­mis­sion­er Stephen Hahn, ac­cord­ing to an in­ter­nal email ob­tained by Politi­co. She will still re­tain her role with OWS and re­main re­cused from de­ci­sion-mak­ing sur­round­ing Covid-19 ther­a­peu­tics.

Ad­di­tion­al­ly, Wood­cock is ex­pect­ed to work on the agency’s Covid-19 Pan­dem­ic Re­cov­ery Pre­pared­ness Plan (PREPP) ini­tia­tive with Anand Shah, deputy com­mis­sion­er for med­ical and sci­en­tif­ic Af­fairs, per a Bio­Cen­tu­ry re­port. The ini­tia­tive, which launched in Au­gust, aims to fig­ure out how Covid-19 pol­i­cy can be im­proved.

Wood­cock, along with Pe­ter Marks, re­cused her­self back in May af­ter join­ing OWS when an ad­vo­ca­cy group ar­gued their roles close to the White House could pose a con­flict of in­ter­est. Giv­en that the pair were ex­pect­ed to help meet Pres­i­dent Trump’s goal of hav­ing a vac­cine by the No­vem­ber elec­tion, crit­ics ar­gued they were not the best judges of the da­ta. — Max Gel­man

NIH, Mod­er­na study pos­si­bil­i­ty of halv­ing vac­cine dose

It may be two months be­fore Mod­er­na and the NIH can con­clude whether they can halve their vac­cine dose and pro­vide the same lev­el of pro­tec­tion, there­by dou­bling the sup­ply.

The idea was first brought to the fore by Mon­cef Slaoui, the head of Op­er­a­tion Warp Speed, who pro­posed slash­ing the Mod­er­na vac­cine dose from 100 μg to 50 μg based on da­ta from a sub­group, aged 18 to 55, who re­ceived that reg­i­men in a Phase II. But the FDA was much less en­thu­si­as­tic about it, is­su­ing a state­ment one day lat­er to say that sug­gest­ing changes to the au­tho­rized dose and sched­ule is “pre­ma­ture.”

The stakes are high be­cause with two emer­gency use au­tho­riza­tions so far, the US has or­dered enough vac­cines for on­ly 185 mil­lion Amer­i­cans out of 300 mil­lion. Vac­ci­na­tions have lagged se­ri­ous­ly be­hind fed­er­al pro­jec­tions of dis­trib­ut­ing 20 mil­lion dos­es by the end of 2020 — less than 5 mil­lion shots have been giv­en so far — but once the cur­rent batch­es are used up, short­ages could oc­cur.

John Mas­co­la

“The to­tal sup­ply of vac­cine has al­ways been a con­cern,” John Mas­co­la, di­rec­tor of the NIH’s Vac­cine Re­search Cen­ter, told the New York Times, “It’s im­por­tant to do these analy­ses that we’re do­ing, and have all that da­ta in our pock­et in the event that there’s a need to use it.”

The FDA will have to sign off on any dos­ing changes.

A few oth­er so­lu­tions have been float­ing around. Soon af­ter Pfiz­er and BioN­Tech be­gan rolling out their mR­NA vac­cine, phar­ma­cists dis­cov­ered that they could ex­tract one, or some­times two, more dos­es out of a vial even af­ter get­ting the rec­om­mend­ed 5 dos­es. The FDA quick­ly ad­vised that those ex­tra dos­es can be found as long as dif­fer­ent vials aren’t mixed to­geth­er.

Oth­ers — and the UK serves as the most no­table ex­am­ple — have ad­vo­cat­ed for pri­or­i­tiz­ing get­ting the first dos­es to more peo­ple rather than mak­ing sure peo­ple get both dos­es on time.

Pfiz­er and BioN­Tech test­ed a reg­i­men of two dos­es giv­en 21 days apart in their Phase III tri­als. The UK ini­tial­ly rec­om­mend­ed that the sec­ond shot be ad­min­is­tered 21 to 28 days af­ter the first, but it’s al­tered the guide­lines to al­low for a gap of up to 12 weeks — an ap­proach spelled out in its au­tho­riza­tion of an­oth­er vac­cine de­vel­oped by As­traZeneca and Ox­ford.

Both Pfiz­er and BioN­Tech have said that there’s no ev­i­dence to sup­port this al­ter­na­tive dos­ing sched­ule. On Tues­day, the WHO gave its rec­om­men­da­tion of keep­ing the vac­ci­na­tions with­in 21 to 28 days but added “a pro­vi­sion for coun­tries in ex­cep­tion­al cir­cum­stances of (Pfiz­er) vac­cine sup­ply con­straints to de­lay the ad­min­is­tra­tion of the sec­ond dose for a few weeks in or­der to max­imise the num­ber of in­di­vid­u­als ben­e­fit­ing from a first dose.”

“We … to­tal­ly ac­knowl­edge that coun­tries may see needs to be even more flex­i­ble in terms of ad­min­is­tra­tion of the sec­ond dose,” Joachim Hom­bach, ex­ec­u­tive of WHO’s Strate­gic Ad­vi­so­ry Group of Ex­perts on Im­mu­niza­tion, told re­porters. “But it is im­por­tant to note that there is very lit­tle … em­pir­i­cal da­ta from the tri­als that un­der­pin this type of rec­om­men­da­tion.”

Pfiz­er/BioN­Tech score new au­tho­riza­tion in Colom­bia

Colom­bia has be­come the lat­est coun­try to au­tho­rize the Pfiz­er/BioN­Tech Covid-19 vac­cine for emer­gency use, paving the way for a roll­out in Feb­ru­ary.

It’s struck a deal to buy 10 mil­lion dos­es of the vac­cine, which would go first to those 60 or old­er with co-mor­bidi­ties and health work­ers. The coun­try has al­so se­cured shots from As­traZeneca/Ox­ford, Janssen and the CO­V­AX coali­tion led by the WHO.

Mex­i­co, Chile and Cos­ta Ri­ca were the first Latin Amer­i­can coun­tries to start mass vac­ci­na­tion with the mR­NA jab de­vel­oped by the US and Ger­man part­ners. Mean­while, Ar­genti­na opt­ed for Rus­sia’s ade­n­ovirus-based Sput­nik V for its ini­tial cam­paign and Brazil has pre-or­dered from Chi­na’s Sino­vac a vac­cine that was be­ing test­ed lo­cal­ly. — Am­ber Tong

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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