Covid-19 roundup: Pfiz­er, BioN­Tech set new pro­duc­tion quo­ta for vac­cine at 2B dos­es in 2021; New da­ta show IL-6 in­hibitor could be ef­fec­tive treat­ment af­ter all

Pfiz­er and BioN­Tech are well on their way to a glob­al roll­out of their mR­NA-based Covid-19 vac­cine, BTN162b2. Even with lo­gis­ti­cal chal­lenges ham­per­ing that plan, Ger­many’s BioN­Tech is plan­ning a vast ex­pan­sion of its pro­duc­tion ca­pac­i­ty in the com­ing year.

BioN­Tech plans to churn out more than 2 bil­lion dos­es of BNT162b2 in 2021, far out­pac­ing the 1 bil­lion dos­es tied up in sup­ply com­mit­ment around the globe, the com­pa­ny said in a vir­tu­al pre­sen­ta­tion at the vir­tu­al JP Mor­gan Health­care Con­fer­ence.

BioN­Tech tied to the re-upped goals to “con­tin­ues process im­prove­ment and ex­pan­sion” at its sites in Ger­many and three Pfiz­er plants in the US. Churn­ing out that many dos­es, how­ev­er, will be con­tin­gent on Pfiz­er and BioN­Tech’s abil­i­ty to keep ic­ing more sup­ply agree­ments to make that com­mit­ment worth­while, the com­pa­ny said.

The roll­out of Covid-19 vac­cines in the US has been much slow­er than ex­pect­ed with a vac­cu­um of lead­er­ship at the fed­er­al lev­el and a hodge-podge vac­ci­na­tion dri­ve at the state lev­el.

New da­ta add new life to Actem­ra’s chances

BAR­DA said they would stop fund­ing IL-6 block­ers for Covid-19 back in Au­gust. But on Jan 7, new re­sults from REMAP-CAP showed Roche’s IL-6 in­hibitor Actem­ra may be worth an­oth­er look.

In a study by the glob­al adap­tive tri­al net­work, pa­tients giv­en the rheuma­toid arthri­tis drug (chem­i­cal­ly known as tocilizum­ab) and sar­ilum­ab with­in 24 hours of en­ter­ing in­ten­sive care saw a 24% re­duc­tion in rel­a­tive risk of death, ac­cord­ing to the UK’s Na­tion­al In­sti­tute for Health Re­search. The treat­ment al­so has the po­ten­tial to short­en in­ten­sive care stays by 10 days, the agency said.

The study in­clud­ed 3,900 Covid-19 pa­tients across 15 Eu­ro­pean coun­tries and was led by Im­pe­r­i­al Col­lege Lon­don, the In­ten­sive Care Na­tion­al Au­dit & Re­search Cen­tre (IC­NARC) in the UK, and Utrecht Uni­ver­si­ty. As of No­vem­ber, 75% of par­tic­i­pants had been re­cruit­ed in the UK through the NIHR’s Clin­i­cal Re­search Net­work. The re­sults have yet to be peer-re­viewed, but re­searchers are work­ing to an­a­lyze and pub­lish them “as soon as pos­si­ble,” the NIHR an­nounced.

The find­ings build on re­sults re­leased in No­vem­ber, in which a da­ta safe­ty and mon­i­tor­ing board re­viewed da­ta from 303 pa­tients and de­ter­mined Actem­ra had a 99.75% chance of be­ing bet­ter for the sick­est Covid-19 pa­tients than giv­ing them no im­mune mod­u­la­tor at all. How­ev­er, the de­gree to which Actem­ra helped pa­tients re­mained un­clear.

“This is a sig­nif­i­cant step for­ward for in­creas­ing sur­vival of pa­tients in in­ten­sive care with COVID-19,” deputy chief med­ical of­fi­cer Jonathan Van-Tam said in a state­ment. “The da­ta shows that tocilizum­ab, and like­ly sar­ilum­ab, speed up and im­prove the odds of re­cov­ery in in­ten­sive care, which is cru­cial for help­ing to re­lieve pres­sure on in­ten­sive care and hos­pi­tals and sav­ing lives.”

The news comes as the UK’s cu­mu­la­tive Covid-19 cas­es top 3 mil­lion, with 59,937 new cas­es in the last 24 hours. A new vari­ant of the virus was de­tect­ed in the UK weeks ago, which sci­en­tists be­lieve may spread more eas­i­ly. Pfiz­er and Mod­er­na have both said they be­lieve their Covid-19 vac­cines will pro­tect against the vari­ant, and are con­duct­ing tests to con­firm. Days ago, Pfiz­er said its jab ap­peared to be ef­fec­tive against the strain in a study con­duct­ed with the Uni­ver­si­ty of Texas Med­ical Branch.

Scott Got­tlieb crit­i­cizes US vac­cine roll­out

As the US strug­gles to get vac­cines in arms, for­mer FDA di­rec­tor Scott Got­tlieb says the coun­try needs a re­set.

“We need to hit the re­set and adopt a new strat­e­gy in try­ing to get out to pa­tients,” he told CBS’ “Face the Na­tion” on Sun­day.

Ac­cord­ing to the CDC, 22.1 mil­lion dos­es have been dis­trib­uted, and 6.68 mil­lion Amer­i­cans have re­ceived their first dose. That’s a far cry from the coun­try’s ini­tial hopes. In De­cem­ber, OWS chief Mon­cef Slaoui said the plan was to dis­trib­ute 40 mil­lion dos­es by the end of De­cem­ber, and vac­ci­nate 100 mil­lion peo­ple by the end of March.

“Right now, there’s 40 mil­lion dos­es sit­ting on a shelf some­where. So the feds say it’s with the states. The states say it’s with the feds. It re­al­ly doesn’t mat­ter to the pa­tient who’s not get­ting ac­cess to to the in­jec­tion,” Got­tlieb told CBS.

To pick up the pace, Pres­i­dent-elect Joe Biden has an­nounced plans to re­lease near­ly all avail­able dos­es, rather than re­serve half of the sup­ply for sec­ond dos­es as the Trump ad­min­is­tra­tion has been do­ing.

Slaoui has pushed the FDA to con­sid­er halv­ing Mod­er­na’s vac­cine to coun­ter­act the dis­tri­b­u­tion lags, but the agency poured cold wa­ter on the idea last week. Chang­ing au­tho­rized vac­cine dos­es or sched­ules for any Covid-19 vac­cine would be “pre­ma­ture” and is not sup­port­ed by avail­able da­ta, FDA chief Stephen Hahn and CBER di­rec­tor Pe­ter Marks said in a joint state­ment. 

“We can­not con­clude any­thing de­fin­i­tive about the depth or du­ra­tion of pro­tec­tion af­ter a sin­gle dose of vac­cine from the sin­gle dose per­cent­ages re­port­ed by the com­pa­nies,” the state­ment read.

A cor­rec­tion has been made to clar­i­fy that REMAP-CAP is not spon­sored by BAR­DA.

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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