President Trump (Evan Vucci/AP Images)

Covid-19 roundup: Trump ad­min­is­tra­tion plan­ning to speed up shots; EMA to re­view As­traZeneca/Ox­ford vac­cine

Fol­low­ing re­ports from Joe Biden’s tran­si­tion team that the Pres­i­dent-elect is plan­ning to re­lease near­ly every avail­able dose of Covid-19 vac­cines when he takes of­fice, the Trump ad­min­is­tra­tion is plan­ning to speed up vac­ci­na­tions be­fore next week’s in­au­gu­ra­tion.

New fed­er­al guide­lines planned for Tues­day will rec­om­mend let­ting every­one old­er than 65 get a vac­cine, as well as all adults at high risk for in­fec­tion, ac­cord­ing to re­ports from Ax­ios and the As­so­ci­at­ed Press. The move would get shots in­to arms rather than hold­ing some dos­es back for sec­ond shots of two-dose reg­i­mens.

States would then de­ter­mine who should get the vac­cine based on CDC guide­lines. The vac­ci­na­tion push would al­so ex­pand where peo­ple can get vac­ci­nat­ed to in­clude com­mu­ni­ty health cen­ters and more phar­ma­cies. In Cal­i­for­nia’s case, base­ball sta­di­ums and Dis­ney­land will al­so serve as vac­ci­na­tion cen­ters, per a New York Times re­port.

Trump’s HHS had been hold­ing back the sec­ond shots de­spite claims from crit­ics that Covid-19 vac­cines were not be­ing dis­trib­uted quick­ly enough. Gov­ern­ment of­fi­cials have dis­trib­uted more than 25 mil­lion dos­es across the coun­try, but on­ly 9 mil­lion Amer­i­cans have re­ceived shots, the CDC said Mon­day.

Biden has made it a pri­or­i­ty of his in­com­ing ad­min­is­tra­tion to try to vac­ci­nate as many peo­ple as pos­si­ble, pledg­ing to get 100 mil­lion shots in­to arms in his first 100 days. It’s yet to be seen whether he can ramp up dis­tri­b­u­tion quick­ly enough to meet that goal.

EMA could au­tho­rize As­traZeneca/Ox­ford vac­cine by the end of Jan­u­ary

As­traZeneca and Ox­ford Uni­ver­si­ty, whose Covid-19 vac­cine tri­als ran in­to trou­ble over the sum­mer due to ad­verse events, could see its jabs au­tho­rized in Eu­rope by the end of the month.

The re­view of the vac­cine is slat­ed to pro­ceed un­der an ac­cel­er­at­ed time­line, the EMA said Tues­day, with a pos­si­ble au­tho­riza­tion de­ci­sion com­ing Jan. 29. Though that date is on­ly less than three weeks from now, the agency said it has al­ready looked at some da­ta from the phar­ma as part of its rolling re­view process.

If en­dorsed by the EMA’s CHMP and for­mal­ly au­tho­rized by the Eu­ro­pean Com­mis­sion, the As­traZeneca/Ox­ford vac­cine would be­come the third avail­able on the con­ti­nent, af­ter the Pfiz­er/BioN­Tech and Mod­er­na vac­cines.

Pas­cal So­ri­ot As­traZeneca

Though the As­traZeneca/Ox­ford vac­cine is cheap­er and eas­i­er to dis­trib­ute, con­cerns arose over its da­ta read­outs that showed it was on­ly 70% ef­fec­tive on av­er­age, com­pared to fig­ures in the mid-90% range by ri­vals. Some re­searchers point­ed out that a sub­pop­u­la­tion who had ac­ci­den­tal­ly re­ceived a half-dose and then a full-dose saw an ef­fec­tive­ness greater than 90%, al­though that end­ed up rais­ing more ques­tions.

But the com­pa­ny re­ceived a vote of con­fi­dence in late De­cem­ber when the vac­cine was au­tho­rized by the UK. CEO Pas­cal So­ri­ot has teased a new ap­proach here, as ex­perts say the vac­cine could be more ef­fec­tive when giv­en three months apart as op­posed to the 28-day sched­ule con­duct­ed dur­ing its tri­als.

Vir and GSK an­ti­body to be ex­am­ined in NHS-backed study

The NHS is back­ing a small tri­al for a new Covid-19 treat­ment in an out­pa­tient set­ting.

Vir and GSK are team­ing up for a Phase Ib/IIa study to eval­u­ate VIR-7832 in pa­tients with mild to mod­er­ate Covid-19 cas­es, the com­pa­nies said Tues­day morn­ing. The pro­gram is a neu­tral­iz­ing an­ti­body with pre­clin­i­cal da­ta sug­gest­ing an abil­i­ty to clear in­fect­ed cells and the po­ten­tial to en­hance virus-spe­cif­ic T-cell func­tion, pro­tect­ing healthy cells from the virus.

The pair hope the lat­ter as­pect could help treat, and pos­si­bly pre­vent, Covid-19 in­fec­tion.

This study will be the first to test the can­di­date in hu­mans. In the Phase Ib por­tion, 24 par­tic­i­pants will be ran­dom­ized 3:1 to re­ceive one dose of the ex­per­i­men­tal drug or place­bo, af­ter which the cho­sen dose will move in­to Phase IIa.

Then, Phase IIa will in­clude three treat­ment arms: 50 pa­tients ran­dom­ized to VIR-7832, 50 pa­tients to a sep­a­rate pro­gram, VIR-7831, and 25 pa­tients to place­bo. The co-pri­ma­ry end­points are safe­ty and vi­ro­log­ic ac­tiv­i­ty of VIR-7832, as mea­sured by a change in SARS-CoV-2 vi­ral load from base­line to day eight.

Tues­day’s an­nounce­ment stems from an April col­lab­o­ra­tion agree­ment be­tween Vir and GSK. VIR-7831, the sec­ond pro­gram in­clud­ed in the Phase IIa por­tion, was se­lect­ed by the NIH in De­cem­ber for a study in mod­er­ate­ly ill hos­pi­tal­ized pa­tients.

IRC warns of in­equitable Covid-19 vac­cine dis­tri­b­u­tion

The In­ter­na­tion­al Res­cue Com­mit­tee, a hu­man­i­tar­i­an aid or­ga­ni­za­tion found­ed by Al­bert Ein­stein in the 1930s, is warn­ing that bil­lions of peo­ple around the world may not re­ceive Covid-19 vac­ci­na­tions this year.

Glob­al short­ages of vac­cines, cou­pled with “vac­cine na­tion­al­ism,” will re­sult in the ma­jor­i­ty of peo­ple in low-in­come and con­flict-af­fect­ed ar­eas miss­ing out on vac­cines in 2021 or pos­si­bly for many years, the or­ga­ni­za­tion said. The WHO-backed ini­tia­tive CO­V­AX, which aims to get vac­cines to these ar­eas, es­ti­mates that at most 20% of these pop­u­la­tions will get vac­ci­nat­ed by the start of next year.

IRC al­so not­ed con­cerns about the re­quire­ment for many of the au­tho­rized vac­cines to be stored in ex­treme­ly cold tem­per­a­tures.

Mes­fin Tek­lu Tesse­ma, se­nior health di­rec­tor for the In­ter­na­tion­al Res­cue Com­mit­tee, said in a state­ment:

“To en­sure no one is left be­hind, in­vest­ments must be made im­me­di­ate­ly to strength­en health sys­tems. This in­cludes shoring up sup­ply chains, al­lo­cat­ing sus­tain­able and ad­e­quate fi­nanc­ing, and em­pow­er­ing front­line and com­mu­ni­ty health work­ers, who can de­liv­er care di­rect­ly to those in need with­in their lo­cal set­tings. To do this, we urge high-in­come coun­tries to in­crease their in­vest­ments to both the CO­V­AX fa­cil­i­ty and broad­er hu­man­i­tar­i­an as­sis­tance that re­mains every bit as es­sen­tial, es­pe­cial­ly giv­en the sever­i­ty of COVID-19’s sec­ondary im­pacts.

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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