Covid-19 roundup: Valneva fires back with booster data of its own; Troubled Atea shifts gears with antiviral

Two weeks ago, Val­ne­va pushed back against a study that found its can­di­date, VLA2001, was the on­ly one out of sev­en test­ed vac­cines that didn’t sig­nif­i­cant­ly boost pro­tec­tion when giv­en to vol­un­teers who had two dos­es of the Pfiz­er/BioN­Tech mR­NA shot.

Val­ne­va said the par­tic­i­pants had been giv­en boost­er dos­es af­ter a short­er in­ter­val than usu­al — and vac­cines made from in­ac­ti­vat­ed virus­es, such as its can­di­date, typ­i­cal­ly re­quire a longer pe­ri­od of time to be ef­fec­tive.

But to­day, Val­ne­va claims its Covid-19 vac­cine can­di­date is now ef­fec­tive as a boost­er for peo­ple who had re­ceived the same shot as an ini­tial vac­ci­na­tion.

Sev­en­ty-sev­en par­tic­i­pants ages 18-55 re­ceived a boost­er dose be­tween 7 and 8 months af­ter be­ing vac­ci­nat­ed with a vary­ing dose of VLA2001 — ei­ther low, medi­um or a high dose lev­el. The 77 re­ceived a sin­gle boost­er vac­ci­na­tion with VLA2001 at the same ‘high’ dosage lev­el, ac­cord­ing to Val­ne­va.

A third dose of VLA2001 elicit­ed an en­hanced im­mune re­sponse, with sim­i­lar an­ti­body lev­els ob­served re­gard­less of whether par­tic­i­pants were ini­tial­ly vac­ci­nat­ed with a low, medi­um or high dose, the biotech said.

‘The com­pa­ny is prepar­ing to launch a ded­i­cat­ed het­erol­o­gous boost­er tri­al, which will eval­u­ate a VLA2001 boost­er shot pro­vid­ed at least six months af­ter pri­ma­ry vac­ci­na­tion with oth­er vac­cines or fol­low­ing nat­ur­al in­fec­tion. This study is ex­pect­ed to com­mence in ear­ly 2022,’ the French biotech said in a press re­lease ear­ly this morn­ing.

The EU’s CHMP drug com­mit­tee said two weeks ago it had start­ed a rolling re­view of Val­ne­va’s vac­cine can­di­date —  which could speed up ap­proval af­ter the EU Com­mis­sion signed a sup­ply deal with Val­ne­va in ear­ly No­vem­ber for up to 60 mil­lion dos­es in 2022 and 2023. — Paul Schloess­er

Atea switch­es things up with its an­tivi­ral, ex­pand­ing tri­al to high-risk, un­vac­ci­nat­ed pa­tients

Af­ter Atea’s Covid-19 an­tivi­ral flopped in a Phase II tri­al — and Roche walked out of their $250 mil­lion part­ner­ship — the biotech says it’s do­ing things a bit dif­fer­ent­ly go­ing for­ward.

Where­as the Phase II tri­al ini­tial­ly in­clud­ed low-risk Covid-19 pa­tients who were vac­ci­nat­ed, Atea says it’s now clos­ing out the Phase III MORN­INGSKY tri­al and open­ing en­roll­ment in the Phase II to un­vac­ci­nat­ed, high-risk out­pa­tients. It’s al­so clos­ing out a fol­low-on tri­al dubbed MEAD­OWSPRING.

‘Af­ter care­ful con­sid­er­a­tion of the rapid evo­lu­tion of SARS-CoV-2 and the emer­gence of vari­ants com­bined with the in­creas­ing avail­abil­i­ty of new COVID-19 treat­ment op­tions, in­clud­ing the an­tic­i­pat­ed new an­tivi­ral reg­i­mens, con­tin­u­ing the MORN­INGSKY tri­al is not the most ef­fec­tive path for­ward,’ chief de­vel­op­ment of­fi­cer Janet Ham­mond said in a state­ment.

Atea will still ad­vance the Phase II tri­al, as­sess­ing AT-527 in pa­tients who are un­vac­ci­nat­ed with risk fac­tors and mod­er­ate Covid-19. While the pre­vi­ous tri­al re­quired pa­tients to be ‘hos­pi­tal­ized or con­fined,’ the com­pa­ny’s re­mov­ing that re­quire­ment go­ing for­ward. The amend­ed Phase II is ex­pect­ed to en­roll up to 200 pa­tients, and a read­out is ex­pect­ed next year.

The biotech faced a big set­back in Oc­to­ber, when AT-527 didn’t re­duce the amount of virus in mild to mod­er­ate Covid-19 pa­tients any more than a place­bo pill did in the Phase II study. That was true for both the pa­tients who re­ceived a high dose and those who re­ceived the low dose. One month lat­er, Roche backed out of its $350 mil­lion joint de­vel­op­ment deal. That part­ner­ship will of­fi­cial­ly end on Feb. 10, Atea said.

Look­ing ahead, Atea’s as­sess­ing AT-527 in com­bi­na­tion with oth­er com­pounds in pre­clin­i­cal stud­ies.

‘We be­lieve strong­ly in AT-527’s po­ten­tial to com­bat the evolv­ing SARS-CoV-2 and emerg­ing vari­ants as a monother­a­py and as an im­por­tant back­bone in po­ten­tial com­bi­na­tion ther­a­py,’ CEO Jean-Pierre Som­ma­dos­si said. —Nicole De­Feud­is 

Fau­ci on Omi­cron: ‘At this point, there is no need for a vari­ant-spe­cif­ic boost­er’

Last week, White House med­ical ad­vi­sor An­tho­ny Fau­ci told STAT that ‘it’s pos­si­ble the cur­rent vac­cines will pro­vide enough pro­tec­tion against the new vari­ant for most vac­ci­nat­ed and boost­ed in­di­vid­u­als.’ He em­pha­sized at the time that he was hy­poth­e­siz­ing, based on how the vac­cines have held up against oth­er SARS-CoV-2 vari­ants.

And yes­ter­day, he ef­fec­tive­ly dou­bled down.

Fau­ci said Wednes­day at a White House brief­ing that the new Omi­cron vari­ant would not re­quire a vari­ant-spe­cif­ic boost­er, which would have meant a fourth dose of the vac­cine for some Amer­i­cans.

‘Our boost­er vac­cine reg­i­mens work against Omi­cron,’ Fau­ci said at a press brief­ing of the White House pan­dem­ic re­sponse team. ‘At this point, there is no need for a vari­ant-spe­cif­ic boost­er.’

So far, full vac­ci­na­tion means two shots of an mR­NA vac­cine man­u­fac­tured by Pfiz­er or Mod­er­na, or a sin­gle shot of the John­son & John­son vac­cine, which does not use mR­NA. But some sci­en­tists, in­clud­ing Fau­ci, have con­ced­ed that a third shot would even­tu­al­ly be nec­es­sary to con­sti­tute full vac­ci­na­tion.

‘I don’t think any­body would ar­gue that op­ti­mal pro­tec­tion is go­ing to be with a third shot,’ Fau­ci said on CNN last week. ‘It’s a tech­ni­cal, al­most se­man­tic de­f­i­n­i­tion, and it is the de­f­i­n­i­tion for re­quire­ments.’

As of yes­ter­day, CDC Di­rec­tor Rochelle Walen­sky said 36 states have de­tect­ed Omi­cron so far, and the vari­ant makes up about 3% of Covid-19 cas­es na­tion­al­ly. — Paul Schloess­er
https://endpts.com/covid-19-roundup-valneva-fires-back-with-booster-data-of-its-own-troubled-atea-shifts-gears-with-antiviral/