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.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

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