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.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.