An­oth­er Covid-19 treat­ment is bit­ing the dust af­ter an in­de­pen­dent Da­ta Safe­ty and Mon­i­tor­ing Board flagged it for lack of ef­fi­ca­cy.

Paris-based Abi­vax shared last week that it’s slam­ming the brakes on its Phase IIb/III clin­i­cal tri­al for ABX464 in high-risk Covid pa­tients. The study, dubbed miR-AGE, had al­ready re­cruit­ed 500 pa­tients of the planned 1,034.

Re­searchers were test­ing the an­ti-in­flam­ma­to­ry to see if it could pre­vent se­vere dis­ease. But a planned in­ter­im analy­sis of da­ta from 306 pa­tients showed no dif­fer­ence be­tween the drug and a place­bo. ABX464 was well-tol­er­at­ed and safe, Abi­vax not­ed.

The re­sults came as a shock to some re­searchers, in­clud­ing Jorge Kalil, a pro­fes­sor at the Uni­ver­si­ty Hos­pi­tal Cen­ter in São Paulo and na­tion­al co­or­di­na­tor of the miR-AGE study in Brazil.

“As an im­mu­nol­o­gist, I am puz­zled by the out­come of the in­ter­im analy­sis, as ABX464 ad­dress­es both the vi­ral and in­flam­ma­to­ry as­pects of the dis­ease,” Kalil said in a state­ment. “How­ev­er, we rec­og­nize that Covid-19 is a nov­el, hy­per-acute and com­plex dis­ease that in­volves var­i­ous vi­ral and in­flam­ma­to­ry path­ways, plus the co­ag­u­la­tion sys­tem, which are still not ful­ly un­der­stood.”

While Abi­vax CEO Hart­mut Ehrlich called the find­ings “dis­ap­point­ing,” he em­pha­sized that ABX464 has shown pos­i­tive da­ta in ul­cer­a­tive col­i­tis, where it was al­ready be­ing test­ed be­fore en­ter­ing the Covid study.

ABX464 isn’t the on­ly po­ten­tial Covid-19 treat­ment can­di­date to come up short. Just last week, the UK’s RE­COV­ERY tri­al halt­ed en­roll­ment in its colchicine study af­ter a da­ta mon­i­tor­ing com­mit­tee saw “no con­vinc­ing ev­i­dence that fur­ther re­cruit­ment would pro­vide con­clu­sive proof of worth­while mor­tal­i­ty ben­e­fit ei­ther over­all or in any pre-spec­i­fied sub­group.”

J&J says it could fall short on Q2 vac­cine sup­ply for EU — re­port

The EU could soon be fac­ing more vac­cine dis­tri­b­u­tion woes, as John­son and John­son wor­ries it won’t be able to meet its Q2 quo­ta.

J&J told the EU that it was “un­der stress” to meet its goal of 55 mil­lion dos­es by the end of June, an un­named EU of­fi­cial told Reuters. The com­pa­ny cit­ed is­sues with the sup­ply of in­gre­di­ents and equip­ment, ac­cord­ing to the of­fi­cial.

The sin­gle-dose vac­cine has al­ready been au­tho­rized by the FDA, and is ex­pect­ed to get the OK for use in the EU on March 11. J&J is on the hook for 200 mil­lion dos­es to the bloc this year, and de­liv­er­ies are ex­pect­ed to start as ear­ly as April, Reuters re­port­ed.

Fail­ing to meet the Q2 goal could spell out a headache for the EU, which has al­ready been deal­ing with dis­tri­b­u­tion lags. Italy threat­ened to take le­gal ac­tion back in Jan­u­ary, al­leg­ing that de­liv­er­ies of the Pfiz­er/BioN­Tech vac­cine were un­ex­pect­ed­ly cut. Ger­many’s Ham­burg al­so re­port­ed re­ceiv­ing a small­er ship­ment. And last week, Italy and the EU blocked a 250,000-dose ship­ment of As­traZeneca’s vac­cine to Aus­tralia to pro­tect its own sup­ply.

Ten­sions rise be­tween EMA and Russ­ian vac­cine de­vel­op­er

Af­ter the head of the EMA’s man­age­ment board ad­vised EU coun­tries to hold off on au­tho­riz­ing Rus­sia’s Sput­nik V vac­cine, the shot’s de­vel­op­ers want an apol­o­gy.

“We de­mand a pub­lic apol­o­gy from EMA’s Christa Wirthumer-Hoche for her neg­a­tive com­ments on EU states di­rect­ly ap­prov­ing Sput­nik V,” a post from the of­fi­cial Sput­nik V Twit­ter ac­count reads. “Her com­ments raise se­ri­ous ques­tions about pos­si­ble po­lit­i­cal in­ter­fer­ence in the on­go­ing EMA re­view.”

Wirthumer-Hoche said dur­ing a talk show on Sun­day that the EU should wait to au­tho­rize the vac­cine while the EMA re­views its safe­ty and ef­fi­ca­cy, ac­cord­ing to a Reuters re­port.

We de­mand a pub­lic apol­o­gy from EMA’s Christa Wirthumer-Hoche for her neg­a­tive com­ments on EU states di­rect­ly ap­prov­ing Sput­nik V. Her com­ments raise se­ri­ous ques­tions about pos­si­ble po­lit­i­cal in­ter­fer­ence in the on­go­ing EMA re­view. Sput­nik V is ap­proved by 46 na­tions.

— Sput­nik V (@sput­nikvac­cine) March 8, 2021

While the vac­cine has been met with much skep­ti­cism, a Lancet study pub­lished last month sug­gests Sput­nik V has an ef­fi­ca­cy rate of 91.6%. The re­sults came from a 20,000-per­son Phase III tri­al, and ef­fi­ca­cy rate was based on the num­ber of Covid-19 cas­es tracked 21 days af­ter the first dose was ad­min­is­tered. Sput­nik V’s pro­tec­tion ap­plied to all age groups, in­clud­ing those old­er than 60, the Lancet re­sults said. No se­ri­ous ad­verse events re­lat­ed to the vac­cine were not­ed, though 45 pa­tients in the vac­cine group ex­pe­ri­enced se­ri­ous side ef­fects un­re­lat­ed to the vac­cine, ac­cord­ing to the Gama­leya Na­tion­al Re­search Cen­ter of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy.

Rus­sia reg­is­tered the vac­cine back in Au­gust — and Pres­i­dent Vladimir Putin says his daugh­ter took it — well be­fore Phase III stud­ies were com­plet­ed. The move spurred much back­lash, in­clud­ing from the As­so­ci­a­tion of Clin­ic Tri­als Or­ga­ni­za­tions, which wrote a let­ter urg­ing Russ­ian health min­is­ter Mikhail Murashko not to give out an un­proven vac­cine.

“EMA did not al­low such state­ments about any oth­er vac­cine. Such com­ments are in­ap­pro­pri­ate and un­der­mine cred­i­bil­i­ty of EMA and its re­view process,” the Sput­nik V ac­count tweet­ed. “Vac­cines and EMA should be above and be­yond pol­i­tics.”

Pfiz­er/BioN­Tech vac­cine neu­tral­izes vari­ant spread­ing in Brazil — study

In a test to see how Pfiz­er and BioN­Tech’s vac­cine fares against new vari­ants emerg­ing around the world, the jab was able to neu­tral­ize the P.1 vari­ant, which was first de­tect­ed in Brazil, ac­cord­ing to a let­ter to the ed­i­tor of the New Eng­land Jour­nal of Med­i­cine. 

The jab al­so neu­tral­ized vari­ants first de­tect­ed in the UK (B.1.1.7-spike) and South Africa (B.1.351-spike), and two sub­sets of mu­ta­tions de­rived from B.1.351 lin­eage. But com­pared to an ear­ly iso­late of the virus, neu­tral­iza­tion of the South Africa vari­ant was weak­er by about two-thirds.

From the let­ter:

Our da­ta are al­so con­sis­tent with poor­er neu­tral­iza­tion of the virus with the full set of B.1.351- spike mu­ta­tions than virus with ei­ther sub­set of mu­ta­tions and sug­gest­ed that virus with mu­tant residues in the re­cep­tor-bind­ing site (K417N, E484K, and N501Y) is more poor­ly neu­tral­ized than virus with Δ242-244, which is lo­cat­ed in the N-ter­mi­nal do­main of the spike pro­tein.

Geo­met­ric mean neu­tral­iz­ing titers against the UK and Brazil vari­ants were “rough­ly equiv­a­lent” to those pro­duced against the ear­ly iso­late, while titers against the South African vari­ant were “ro­bust but low­er,” the au­thors from the Uni­ver­si­ty of Texas Med­ical Branch wrote.

Pri­or stud­ies have sug­gest­ed that Pfiz­er and BioN­Tech’s vac­cine can pro­tect against vari­ants spread­ing in the UK and South Africa, though may be less po­tent against the South Africa vari­ant. The com­pa­nies are test­ing boost­er op­tions, in­clud­ing a third dose of the cur­rent vac­cine and a new for­mu­la­tion that specif­i­cal­ly tar­gets the vari­ant.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.