Covid-19 roundup: Valneva defends vaccine in wake of unflattering booster study; Merck goes after Pfizer’s new antiviral — report

Falling way be­hind the fron­trun­ners in de­liv­er­ing a Covid-19 vac­cine, French biotech Val­ne­va has placed high hopes on boost­ers.

Which may be why it is re­act­ing strong­ly to a study sug­gest­ing that its can­di­date, VLA2001, was the on­ly one out of sev­en that didn’t work well as a boost­er for vol­un­teers who had dos­es of the Pfiz­er/BioN­Tech mR­NA shot.

The com­pa­ny is try­ing to fire back Mon­day morn­ing, days af­ter re­sults from the COV-Boost study were pub­lished in The Lancet.

That tri­al, Val­ne­va not­ed, was de­signed to help the UK gov­ern­ment make a quick de­ci­sion on the au­tumn boost­er cam­paign. In that spir­it, par­tic­i­pants were giv­en a boost­er dose ‘rel­a­tive ear­ly,’ on­ly two to three months af­ter the sec­ond dose of the pri­ma­ry vac­ci­na­tion se­ries. It found that while VLA2001 spiked an­ti­body lev­els af­ter two As­traZeneca/Ox­ford jabs, like all the oth­ers test­ed, it didn’t have the same ef­fect fol­low­ing the Pfiz­er/BioN­Tech reg­i­men.

‘Val­ne­va be­lieves it is like­ly that the short in­ter­val be­tween the sec­ond shot and boost­er shot could have ad­verse­ly im­pact­ed the re­sults for VLA2001, giv­en that a longer in­ter­val is gen­er­al­ly re­quired for in­ac­ti­vat­ed vac­cines,’ the com­pa­ny wrote.

In­ves­ti­ga­tors in the tri­al mea­sured im­mu­ni­ty in terms of an­ti­body lev­els, they added, which is at most a mark­er of im­mune re­sponse rather than vac­cine ef­fec­tive­ness.

‘The set­ting in the study leads us to be­lieve that COV-Boost does not al­low any con­clu­sions to be reached re­gard­ing the use of VLA2001 as a boost­er in a re­al-life set­ting,’ Val­ne­va CMO Juan Car­los Jaramil­lo said in a state­ment. ‘The pro­tec­tive an­ti­body thresh­old has not yet been es­tab­lished there­fore rel­a­tive in­creas­es in an­ti­body lev­els should not be seen as in­dica­tive of ef­fi­ca­cy.’ — Am­ber Tong

Mer­ck goes af­ter Pfiz­er’s new an­tivi­ral — re­port

Af­ter an FDA pan­el nar­row­ly en­dorsed Mer­ck’s mol­nupi­ravir in a 13-10 vote, Mer­ck is of­fer­ing a pre­emp­tive de­fense of its an­tivi­ral pill against a ri­val treat­ment from Pfiz­er.

Ac­cord­ing to Mer­ck’s SVP of glob­al med­ical af­fairs Eli­av Barr, the fact that Pfiz­er’s new an­tivi­ral has to be tak­en with Pfiz­er’s ri­ton­avir, an an­ti-HIV drug, would make the treat­ment ‘un­suit­able’ for pa­tients with pre-ex­ist­ing con­di­tions.

‘The prob­lem is that it’s [Ri­ton­avir] in­cred­i­bly non-spe­cif­ic,’ Barr told the Fi­nan­cial Times. ‘So there’s a whole host of med­i­cines that peo­ple take, es­pe­cial­ly those med­i­cines, un­for­tu­nate­ly, that are as­so­ci­at­ed with con­di­tions that con­fer risk.’

And while there was a study pub­lished in Na­ture about drug-on-drug in­ter­ac­tions in pa­tients treat­ed with ri­ton­avir and Ab­b­Vie’s lopinavir, Pfiz­er shot back, say­ing their drug is safe and any po­ten­tial drug-drug in­ter­ac­tions can be man­aged through dose-ad­just­ment while on its an­tivi­ral.

The ball is now in reg­u­la­tors’ court. If the FDA grants the EUA for mol­nupi­ravir, the US gov­ern­ment has a con­tract to buy 3.1 mil­lion cours­es for $2.2 bil­lion. — Paul Schloess­er

New WHO re­port sheds light on reg­u­la­to­ry in­ner work­ings lead­ing to speedy ap­provals

In hind­sight, speedy re­views for Covid-19 vac­cines and treat­ments — cou­pled with flex­i­ble arrange­ments tak­ing in­to ac­count pan­dem­ic re­stric­tions — seem in­tu­itive. But how ex­act­ly do they hap­pen?

The WHO shed some light on the in­ner work­ings at reg­u­la­to­ry au­thor­i­ties around the world in a new re­port re­leased to­geth­er with the In­ter­na­tion­al Coali­tion of Med­i­cines Reg­u­la­to­ry Au­thor­i­ties, af­ter sur­vey­ing mul­ti­ple agen­cies and re­view­ing the prac­tices — both reg­u­la­to­ry flex­i­bil­i­ties and ex­tra­or­di­nary mea­sures — they adopt­ed.

The most com­mon mech­a­nisms of­fered by reg­u­la­tors in­clude quick, fre­quent and con­tin­u­ous com­mu­ni­ca­tions, which all 11 agen­cies sur­veyed said they put in place.

At the bot­tom of the list, mean­while, were spe­cif­ic prac­tices of re­ly­ing on oth­er coun­tries for as­sess­ment of drugs and vac­cines, such as par­tic­i­pa­tion in joint re­view pro­grams and full or par­tial re­liance.

‘There has been ex­ten­sive ex­change of in­for­ma­tion on GMP com­pli­ance amongst In­ter­na­tion­al Reg­u­la­tors, paving the path for more re­liance be­tween In­ter­na­tion­al Part­ners,’ the WHO and the ICM­RA wrote. ‘Re­mote in­spec­tions have been a use­ful tool com­ple­ment­ing GMP com­pli­ance ver­i­fi­ca­tion.’ They em­pha­sized that in­stead of lead­ing to a re­duc­tion in reg­u­la­to­ry stan­dards, these flex­i­bil­i­ties and ear­ly ap­proval ac­tu­al­ly re­flect­ed ‘greater process and prod­uct knowl­edge’ that en­abled man­u­fac­tur­ers to lever­age those flex­i­bil­i­ties.

Dur­ing a work­shop they con­vened to ex­change ideas, the in­sti­tu­tions added that dif­fer­ent stake­hold­ers iden­ti­fied bot­tle­necks lim­it­ing the use of reg­u­la­to­ry pro­ce­dures. From the reg­u­la­tor’s per­spec­tive, lim­it­ed or in­ad­e­quate da­ta, lack of en­gage­ment, lim­it­ed ca­pac­i­ty or re­sources and chang­ing timeta­bles made it dif­fi­cult to ap­ply spe­cial mea­sures; where­as for the in­dus­try, lack of reg­u­la­to­ry re­liance, con­straints of ex­ist­ing leg­is­la­tion, vol­ume of ques­tions, full na­tion­al re­lease test­ing of vac­cines, ex­pec­ta­tions of com­plete dossier in­for­ma­tion and lack of clear com­mu­ni­ca­tion path­ways, among oth­ers, were key kin­drances.
https://endpts.com/covid-19-roundup-valneva-defends-vaccine-in-wake-of-unflattering-booster-study-merck-goes-after-pfizers-new-antiviral-report/