Ugur Sahin, BioNTech CEO (Andreas Arnold/dpa via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech/Mod­er­na test vac­cines against new UK vari­ant; Ocu­gen strikes deal for US rights to PhI­II vac­cine

Both Pfiz­er/BioN­Tech and Mod­er­na have said their can­di­dates should pro­tect against a new vari­ant of coro­n­avirus that has been de­tect­ed in the UK, and are con­duct­ing tests to prove it.

BioN­Tech CEO Ugur Sahin has said it’s “high­ly like­ly” that their vac­cine de­vel­oped with Pfiz­er will be ef­fec­tive against the new vari­ant, which sci­en­tists wor­ry could spread more eas­i­ly than the cur­rent strain. There’s no ev­i­dence right now that the mu­ta­tion caus­es more se­ri­ous ill­ness. But to be safe, mul­ti­ple coun­tries are block­ing trav­el from the UK.

“We don’t know at the mo­ment if our vac­cine is al­so able to pro­vide pro­tec­tion against this new vari­ant,” Sahin said in a news con­fer­ence, per ABC News. “But sci­en­tif­i­cal­ly, it is high­ly like­ly that the im­mune re­sponse by this vac­cine al­so can deal with the new virus vari­ants.”

While fur­ther study will be nec­es­sary to con­firm the the­o­ry, Sahin not­ed that the pro­teins on the vari­ant are 99% sim­i­lar to pri­or strains. If need­ed, the vac­cine could be ad­just­ed in 6 weeks, he said, ac­cord­ing to ABC.

Mod­er­na has al­so said its vac­cine like­ly pro­tects against the new vari­ant, ac­cord­ing to Forbes. In a state­ment, they said da­ta sug­gest their can­di­date’s “vac­cine-in­duced im­mu­ni­ty would be pro­tec­tive against the vari­ants re­cent­ly de­scribed in the U.K.”

The first dos­es of Pfiz­er/BioN­Tech’s re­cent­ly ap­proved vac­cine were giv­en out across the US last week, and Mod­er­na’s vac­cine was not far be­hind. On Mon­day, Pres­i­dent-elect Joe Biden re­ceived a shot as part of a cam­paign to con­vince oth­er Amer­i­cans to get vac­ci­nat­ed.

Ocu­gen strikes deal for US rights to PhI­II vac­cine

Penn­syl­va­nia-based Ocu­gen and has inked a deal with In­dia’s Bharat Biotech to co-de­vel­op its whole-viri­on in­ac­ti­vat­ed vac­cine can­di­date Co­v­ax­in for the US mar­ket.

The can­di­date, which was de­vel­oped through a col­lab­o­ra­tion with the In­di­an Coun­cil of Med­ical Re­search/Na­tion­al In­sti­tute of Vi­rol­o­gy, is cur­rent­ly in a Phase III tri­al in In­dia with 26,000 vol­un­teers. It has al­ready been test­ed in 1,000 peo­ple in Phase I and II tri­als there, which turned up “promis­ing safe­ty and im­muno­genic­i­ty da­ta,” ac­cord­ing to the com­pa­nies.

As part of the deal, Ocu­gen will have US rights to the can­di­date, where it will be re­spon­si­ble for clin­i­cal de­vel­op­ment, reg­is­tra­tion and com­mer­cial­iza­tion in col­lab­o­ra­tion with Bharat. The com­pa­nies kept qui­et about the fi­nan­cial terms of the deal, but said they ex­pect to have the fi­nal de­tails ironed out in the next few weeks.

“CO­V­AX­IN uti­lizes a his­tor­i­cal­ly proven ap­proach to vac­cine de­sign,” Har­vey Ru­bin, a mem­ber of Ocu­gen’s Vac­cine Sci­en­tif­ic Ad­vi­so­ry Board, said in a state­ment. “The ad­ju­vant­ed in­ac­ti­vat­ed virus vac­cine can­di­date elicit­ed strong IgG re­spons­es against spike (S1) pro­tein, re­cep­tor-bind­ing do­main (RBD) and the nu­cle­o­cap­sid (N) pro­tein of SARS-CoV-2 along with strong cel­lu­lar re­spons­es in Phase 1 and 2 clin­i­cal tri­als. CO­V­AX­IN of­fers a vac­cine can­di­date that is dif­fer­ent from oth­er op­tions cur­rent­ly avail­able in the US mar­ket with po­ten­tial­ly broad­er cov­er­age against mul­ti­ple pro­tein anti­gens of the virus.”

Back in Au­gust, Bharat chair­man Kr­ish­na El­la said the com­pa­ny is pri­or­i­tiz­ing safe­ty and qual­i­ty over speed, per a Busi­ness Stan­dard re­port.

Eu­ro­pean Com­mis­sion au­tho­rizes Pfiz­er/BioN­Tech vac­cine

Weeks af­ter it was green­light­ed in the UK, Pfiz­er and BioN­Tech’s Covid-19 vac­cine was giv­en the thumbs-up by the Eu­ro­pean Com­mis­sion.

The of­fi­cial word came hours af­ter the EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use rec­om­mend­ed the agency move for­ward with con­di­tion­al mar­ket­ing au­tho­riza­tion on Mon­day. The first shots could be de­liv­ered in some states as ear­ly as Sun­day, ac­cord­ing to the BBC.

The vac­cine will be mar­ket­ed in Eu­rope as Comir­naty, a com­bi­na­tion of the terms Covid-19, mR­NA, com­mu­ni­ty and im­mu­ni­ty, ac­cord­ing to a state­ment by Pfiz­er and BioN­Tech.

“As a com­pa­ny found­ed and head­quar­tered in the heart of Eu­rope, we are look­ing for­ward to de­liv­er­ing the vac­cine to Eu­ro­peans in the up­com­ing days,” BioN­Tech CEO Ugur Sahin said in a state­ment. “We be­lieve that vac­ci­na­tions may help re­duce the num­ber of peo­ple in high-risk pop­u­la­tions be­ing hos­pi­tal­ized. Mov­ing for­ward, we will con­tin­ue to col­lect ef­fi­ca­cy and safe­ty da­ta in par­tic­i­pants for an ad­di­tion­al two years and test the vac­cine against ad­di­tion­al mu­ta­tions that might oc­cur.”

In No­vem­ber, Pfiz­er and BioN­Tech inked a deal with the EC for 200 mil­lion dos­es in 2020 in 2021, with the op­tion to se­cure up to 100 mil­lion more. The dos­es will be de­liv­ered in stages, and will be pro­duced at BioN­Tech’s Ger­man man­u­fac­tur­ing sites and Pfiz­er’s site in Bel­gium. The com­pa­nies say they can de­liv­er 50 mil­lion shots glob­al­ly by the end of this month and up to 1.3 bil­lion by the end of next year.

Al­bert Bourla

BioN­Tech plans on in­creas­ing its man­u­fac­tur­ing sup­ply next year with a third site in Mar­burg, Ger­many. Pfiz­er’s Pu­urs, Bel­gium site will be used pri­mar­i­ly for Eu­ro­pean sup­ply, as well as a back-up sup­ply to Kala­ma­zoo, MI.

More than 40 coun­tries have au­tho­rized the vac­cine so far, in­clud­ing the 27 EU mem­ber states, the UK, Cana­da, the US, Mex­i­co, Sau­di Ara­bia, Sin­ga­pore, Bahrain, Chile and Jor­dan.

“With the pan­dem­ic still rag­ing in many coun­tries, we are con­tin­u­ing to work around the clock to bring this vac­cine to the world as quick­ly, ef­fi­cient­ly and eq­ui­tably as pos­si­ble,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

Brazil tri­als show Sino­vac can­di­date is at least 50% ef­fec­tive — re­port

Af­ter hold­ing on­to ef­fi­ca­cy da­ta for Sino­vac’s Covid-19 vac­cine a bit longer than ex­pect­ed to get a more com­plete analy­sis, those in­volved in Brazil­ian clin­i­cal tri­als say the can­di­date is more than 50% ef­fec­tive.

Un­named sources told the Wall Street Jour­nal that the Chi­nese vac­cine passed the 50% ef­fi­ca­cy thresh­old that in­ter­na­tion­al sci­en­tists have set as a stan­dard, but didn’t give any more specifics.

“Every­one is hop­ing for an ef­fi­ca­cy rate above 90%,” Domin­gos Alves, a pro­fes­sor at Ribeirão Pre­to Med­ical School in São Paulo told the WSJ. “The re­sults from the first phas­es of tri­als were very good.”

Sino­vac‘s can­di­date, Coro­n­aVac, im­ple­ments in­ac­ti­vat­ed virus to trig­ger an im­mune re­sponse.

Last week, São Paulo Gov. João Do­ria an­nounced an ef­fi­ca­cy read­out would be de­layed by one week — un­til Dec. 23 — to get a larg­er sam­ple size, ac­cord­ing to a Reuters re­port. Tri­al or­ga­niz­ers said back in No­vem­ber that a first Phase III look at the Chi­nese can­di­date would come ear­ly this month. And Do­ria has promised to be­gin vac­ci­na­tions on Jan. 25, per Reuters.

Back in No­vem­ber, the Brazil­ian tri­al was briefly halt­ed fol­low­ing the death of a par­tic­i­pant. Brazil re­versed its halt soon af­ter, and the state gov­ern­ment re­vealed that the vol­un­teer had died by sui­cide.

The US’ two lead­ing vac­cines, de­vel­oped by Pfiz­er/BioN­Tech and Mod­er­na, tout ef­fi­ca­cy rates of 95% and 94.1%, re­spec­tive­ly. Sci­en­tists in­volved in the Coro­n­aVac tri­als say they ex­pect to track an ef­fi­ca­cy rate sim­i­lar to those vac­cines, ac­cord­ing to the WSJ.

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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