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.

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What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

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Covid-19 roundup: CDC ad­vi­sors find like­ly link be­tween mR­NA vac­cines and rare cas­es of heart in­flam­ma­tion; NIH launch­es new vac­cine study in preg­nant vol­un­teers 

The FDA will update the fact sheets for the Pfizer/BioNTech and Moderna Covid-19 vaccines, after the CDC advisory group ACIP found that rare cases of heart inflammation in adolescents and young adults are likely linked to the shots, Reuters reported.

According to the CDC’s website, there have been more than a thousand reports of heart inflammation following mRNA vaccination since April. These cases are rare, according to the agency, given the hundreds of millions of doses administered. Most have been mild, and individuals often recover on their own or with minimal treatment, several public health figures said in a joint statement.