Covid-19 roundup: Pfiz­er, BioN­Tech study sug­gest vac­cine works against vari­ants; Re­searchers say Sino­vac's vac­cine is 78% ef­fec­tive

Amid height­ened con­cerns about new, large­ly un­known vari­ants of SARS-CoV-2 that ap­pear to spread more rapid­ly, Pfiz­er and BioN­Tech say they have pre­lim­i­nary ev­i­dence that their Covid-19 vac­cine is still ef­fec­tive against coro­n­avirus­es with one key mu­ta­tion.

Pfiz­er part­nered with the Uni­ver­si­ty of Texas Med­ical Branch on an in vit­ro study, in which the aca­d­e­m­ic sci­en­tists gen­er­at­ed a virus with the N501Y mu­ta­tion, which they say is shared by the SARS-CoV-2 vari­ants re­port­ed in the UK and South Africa. This par­tic­u­lar mu­ta­tion is lo­cat­ed in the re­cep­tor bind­ing site of the spike pro­tein — the pro­tein that the BNT162b2 vac­cine en­codes in an mR­NA mol­e­cule.

They then took sera sam­ples from 20 par­tic­i­pants who re­ceived the vac­cine in the Phase III tri­al, and test­ed them against the N501Y mu­ta­tion as well as a pan­el of 15 pseudovirus­es bear­ing spikes with oth­er mu­ta­tions.

The re­sults, they wrote in a preprint, sug­gest­ed that the an­ti­bod­ies in­duced by the vac­cine “neu­tral­ized the virus with the mu­ta­tion as well as they neu­tral­ized virus with­out the mu­ta­tion.”

This in­di­cates that the key N501Y mu­ta­tion, which is found in the emerg­ing U.K and South Africa vari­ants, does not cre­ate re­sis­tance to the Pfiz­er-BioN­Tech vac­cine in­duced im­mune re­spons­es.

While it’s en­cour­ag­ing news, Pfiz­er and BioN­Tech not­ed, more da­ta are need­ed to mon­i­tor the ef­fec­tive­ness of the vac­cine in a re­al-world set­ting. — Am­ber Tong

Ger­man vac­cine can­di­date fails ear­ly-stage tri­al

The first vac­cines for Covid-19 have been de­vel­oped with­out much hic­cup. But fail­ures — an all-too-com­mon oc­cur­rence in bio­phar­ma — still crop up.

To­day’s re­minder comes from Ger­many, where the Ger­man Cen­tre for In­fec­tion Re­search and vac­cine mak­er IDT Bi­ologi­ka said their can­di­date didn’t prompt the an­tic­i­pat­ed lev­el of im­mune re­ac­tion in ear­ly-stage clin­i­cal tri­als.

The re­searchers are sus­pend­ing dos­ing un­til they fig­ure out what’s go­ing on. For the tri­al, which took place in Ham­burg, 30 vol­un­teers had re­ceived the jab.

IDT was orig­i­nal­ly hop­ing to ap­ply for reg­u­la­to­ry ap­proval at the end of 2021, Reuters not­ed. — Am­ber Tong

Re­searchers say Sino­vac’s vac­cine is 78% ef­fec­tive

Brazil’s Bu­tan­tan In­sti­tute has an­nounced that Sino­vac’s vac­cine can­di­date is 78% ef­fec­tive — a rate much low­er than that of Pfiz­er/BioN­Tech and Mod­er­na’s can­di­dates, but high enough to make a dif­fer­ence in de­vel­op­ing coun­tries where some wor­ry vac­cines won’t be avail­able for years, the Wall Street Jour­nal re­port­ed. 

The news comes weeks af­ter un­named sources in­volved in the Brazil­ian tri­als told the WSJ that the vac­cine was at least 50% ef­fec­tive. The Chi­nese can­di­date, Coro­n­aVac, us­es in­ac­ti­vat­ed virus to trig­ger an im­mune re­sponse. Sino­vac and In­sti­tu­to Bu­tan­tan, a Brazil­ian im­muno­bi­o­log­ic man­u­fac­tur­er, signed a deal back in June to ad­vance clin­i­cal tri­als to Phase III.

While Pfiz­er/BioN­Tech and Mod­er­na re­port­ed ef­fi­ca­cy rates of 95% and 94.5% for their mR­NA jabs, re­spec­tive­ly, some are con­cerned it could be years be­fore they reach low-in­come coun­tries. Ac­cord­ing to in­ter­nal pa­pers re­gard­ing the WHO, CEPI and Gavi-led CO­V­AX pro­gram ac­cessed by Reuters last month, a lack of funds, sup­ply risks and com­plex con­trac­tu­al arrange­ments could leave those in poor na­tions with­out vac­cines un­til 2024.

Last month, re­search pa­pers in The BMJ, a peer-re­viewed jour­nal by the British Med­ical As­so­ci­a­tion, said those in low-in­come coun­tries have lit­tle chance of get­ting in­oc­u­lat­ed this year. Even if vac­cine man­u­fac­tur­ers suc­cess­ful­ly reached their max­i­mum pro­duc­tion ca­pac­i­ty, at least a fifth of the world’s pop­u­la­tion might not have ac­cess to vac­cines un­til 2022, An­tho­ny So and Joshua Woo pre­dict­ed in one pa­per.

“At least 90% of peo­ple in 67 low in­come coun­tries stand lit­tle chance of get­ting vac­ci­nat­ed against covid-19 in 2021 be­cause wealthy na­tions have re­served more than they need and de­vel­op­ers will not share their in­tel­lec­tu­al prop­er­ty,” Owen Dy­er wrote in an­oth­er pa­per, cit­ing the Peo­ple’s Vac­cine Al­liance.

“There are a large num­ber of de­vel­op­ing coun­tries that haven’t been able to se­cure sup­plies,” Prashant Ya­dav, a glob­al health spe­cial­ist at the Wash­ing­ton-based Cen­ter for Glob­al De­vel­op­ment, told the WSJ. “This could be­come a very vi­able op­tion for them.”

Coro­n­aVac was au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment back in Ju­ly.

In ear­ly De­cem­ber, Sino­vac struck a deal with Chi­na’s Sino Bio­phar­ma­ceu­ti­cal for $515 mil­lion to dou­ble pro­duc­tion ca­pac­i­ty. In re­turn, Sino Bio­phar­ma­ceu­ti­cal will get a 15.03% in­ter­est in Sino­vac Life Sci­ences. At the time, Sino­vac said it would be able to pump out up to 600 mil­lion dos­es an­nu­al­ly with an added pro­duc­tion fa­cil­i­ty. — Nicole De­Feud­is 

EU locks down near­ly half of Pfiz­er’s 2021 vac­cine sup­ply

In a move that se­cured near­ly half of Pfiz­er and BioN­Tech’s 2021 out­put, the EU has closed a deal with the com­pa­nies for up to 300 mil­lion more dos­es of their vac­cine, Reuters re­port­ed Fri­day.

The bloc had al­ready signed an agree­ment for 300 mil­lion dos­es in No­vem­ber, po­ten­tial­ly giv­ing it ac­cess to 600 mil­lion to­tal. Pfiz­er has said it can pro­duce up to 1.3 bil­lion dos­es this year, and with the EU com­pris­ing a pop­u­la­tion of rough­ly 450 mil­lion peo­ple, Fri­day’s deal could al­low for up to two-thirds of the con­ti­nent to be in­oc­u­lat­ed should dis­tri­b­u­tion run smooth­ly.

With the move, EU mem­ber states will be able to put in or­ders for the new dos­es start­ing in April, Eu­ro­pean Com­mis­sion chief Ur­su­la von der Leyen said at a news con­fer­ence. Sev­en­ty-five mil­lion of the ad­di­tion­al dos­es would be de­liv­ered in the sec­ond quar­ter of this year, and the rest by the end of 2021.

The agree­ment in­cludes a pos­si­ble im­me­di­ate or­der for 200 mil­lion dos­es and an ad­di­tion­al op­tion to buy an­oth­er 100 mil­lion, the Com­mis­sion said in a state­ment.

Fri­day’s move comes af­ter con­cern among some mem­ber states that Ger­many’s sep­a­rate deal with BioN­Tech last Sep­tem­ber would cre­ate un­nec­es­sary com­pe­ti­tion for the vac­cine. The EU was aware of the deal at the time, which Ger­many first an­nounced Mon­day and pro­vid­ed for 30 mil­lion dos­es on a bi­lat­er­al ba­sis.

Al­so in Sep­tem­ber, Ger­many front­ed BioN­Tech about $460 mil­lion in fund­ing to help ac­cel­er­ate re­search and pro­duc­tion in the coun­try.

The Eu­ro­pean Com­mis­sion au­tho­rized the Pfiz­er/BioN­Tech vac­cine in late De­cem­ber. Pfiz­er has al­so signed deals with the US gov­ern­ment to pro­vide up to 200 mil­lion dos­es by Ju­ly 31, 2021, and in­cludes an op­tion to pur­chase up to 400 mil­lion more down the road. — Max Gel­man

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.

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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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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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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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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