The EMA said Thurs­day that Eu­ro­pean coun­tries can be­gin to use Pfiz­er’s Covid-19 treat­ment pill Paxlovid, even though it is not yet au­tho­rized in the EU.

The pill is in­di­cat­ed to treat adults with Covid-19 who do not re­quire sup­ple­men­tal oxy­gen and who are at in­creased risk of pro­gress­ing to se­vere dis­ease.

The ear­ly ad­vice is based on clin­i­cal tri­al da­ta from Pfiz­er show­ing 1% of pa­tients (6 out of 607) who took Paxlovid with­in five days of the start of symp­toms were hos­pi­talised with­in 28 days of start­ing treat­ment com­pared with 6.7% of pa­tients (41 out of 612) giv­en place­bo.

The FDA has yet to au­tho­rize Pfiz­er’s pill. — Zachary Bren­nan

As­traZeneca’s long-act­ing an­ti­body works against Omi­cron

New pre­clin­i­cal da­ta re­leased by As­traZeneca on Thurs­day shows that its long-act­ing an­ti­body Evusheld (tix­agevimab co-pack­aged with cil­gav­imab), which is au­tho­rized for the pre­ven­tion of Covid-19, still works against the Omi­cron vari­ant.

The ear­ly da­ta, gen­er­at­ed as part of an in­de­pen­dent as­sess­ment from FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, showed that pseudovirus test­ing of the full Omi­cron vari­ant spike against the As­traZeneca mAb com­bo adds to the grow­ing body of pre­clin­i­cal ev­i­dence demon­strat­ing that it “re­tains ac­tiv­i­ty against all test­ed vari­ants of con­cern to date,” As­traZeneca said in a state­ment.

The FDA au­tho­rized the com­bo last week to pre­vent Covid-19 in pa­tients who are im­muno­com­pro­mised, pro­vid­ing the first lev­el of ad­di­tion­al pro­tec­tion for peo­ple who may not be ad­e­quate­ly pro­tect­ed by vac­cines.

Mean­while, Re­gen­eron, which said ear­li­er that its mAb com­bo doesn’t fare well against Omi­cron, an­nounced Thurs­day that its mul­ti­ple next-gen mAbs from its col­lec­tion of mAbs tar­get­ing SARS-CoV-2 are ac­tive against the Omi­cron and Delta vari­ants, as well as oth­er vari­ants of con­cern.

“Pend­ing reg­u­la­to­ry dis­cus­sions, we an­tic­i­pate en­ter­ing the clin­ic in the first quar­ter of 2022,” the com­pa­ny said. — Zachary Bren­nan

Val­ne­va fires back with boost­er da­ta of its own

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 

EMA signs off on two new Covid treat­ments

The Eu­ro­pean Med­i­cines Agency on Thurs­day rec­om­mend­ed au­tho­riz­ing Glax­o­SmithK­line and Vir’s mon­o­clon­al an­ti­body Xe­vudy (sotro­vimab) for the treat­ment of Covid-19 in adults and ado­les­cents (from 12 years of age and weigh­ing at least 40 kilo­grams) who do not re­quire sup­ple­men­tal oxy­gen and who are at in­creased risk of the dis­ease be­com­ing se­vere.

The mAb, which al­so is au­tho­rized in the US, is the third mon­o­clon­al rec­om­mend­ed in the EU for treat­ing Covid and fol­lows the ap­proval of Cell­tri­on’s Regkirona, which is not au­tho­rized in the US, and Re­gen­eron’s Ron­apreve in No­vem­ber.

In ad­di­tion, the EMA rec­om­mend­ed au­tho­riz­ing Swedish Or­phan Biovit­rum’s Kineret, which is not avail­able in the US, to treat Covid-19 in adult pa­tients with pneu­mo­nia re­quir­ing sup­ple­men­tal oxy­gen (low or high flow oxy­gen) and who are at risk of de­vel­op­ing se­vere res­pi­ra­to­ry fail­ure, as de­ter­mined by blood lev­els of a pro­tein called su­PAR (sol­u­ble uroki­nase plas­mino­gen ac­ti­va­tor re­cep­tor) of at least 6 ng per ml. — Zachary Bren­nan

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

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.