Pfiz­er and BioN­Tech an­nounced Tues­day that they’ve ini­ti­at­ed a clin­i­cal study to eval­u­ate the safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty of an Omi­cron-tar­get­ed vac­cine can­di­date in healthy adults 18 through 55 years of age, al­though it re­mains un­clear when, if ever, that vac­cine might be nec­es­sary.

Draw­ing on some of the par­tic­i­pants from the com­pa­nies’ Phase III boost­er study, the tri­al will en­roll up to 1,420 par­tic­i­pants and eval­u­ate three groups of healthy adults up to the age of 55, in­clud­ing one group who re­ceived 2 dos­es of the Pfiz­er vac­cine and will get one shot of the Omi­cron-spe­cif­ic boost­er, one group that re­ceived three dos­es of the Pfiz­er vac­cine and will get one of the Omi­cron-based vac­cines, and then a third group re­ceiv­ing three dos­es of the Omi­cron-based vac­cine.

“While cur­rent re­search and re­al-world da­ta show that boost­ers con­tin­ue to pro­vide a high lev­el of pro­tec­tion against se­vere dis­ease and hos­pi­tal­iza­tion with Omi­cron, we rec­og­nize the need to be pre­pared in the event this pro­tec­tion wanes over time and to po­ten­tial­ly help ad­dress Omi­cron and new vari­ants in the fu­ture,” Kathrin Jansen, head of vac­cine R&D at Pfiz­er, said in a state­ment.

The com­pa­nies said they ex­pect to pro­duce 4 bil­lion dos­es of the Pfiz­er/BioN­Tech vac­cine this year, and that ca­pac­i­ty is not ex­pect­ed to change if an Omi­cron-adapt­ed vac­cine is re­quired.

Britain looks to en­roll thou­sands more in mol­nupi­ravir tri­al to see if Mer­ck’s pill works

The UK gov­ern­ment said on Tues­day it needs to re­cruit 6,000 more peo­ple in­to a tri­al for Mer­ck’s Covid-19 pill mol­nupi­ravir be­fore it can be dis­trib­uted more wide­ly.

First ap­proved by Britain’s drug reg­u­la­tor in No­vem­ber, the UK launched a na­tion­al study to es­tab­lish the best way to use the drug.

Ac­cord­ing to Reuters, the UK health min­istry said that while more than 4,500 tri­al par­tic­i­pants had signed up for the tri­al, dubbed Panoram­ic, thou­sands more were need­ed to gath­er the da­ta need­ed.

Eu­ro­pean and Cana­di­an reg­u­la­tors of­fer a peek in­to Mod­er­na’s vac­cine da­ta

The Eu­ro­pean Med­i­cines Agency and Health Cana­da took the proac­tive step to­ward more trans­paren­cy around Covid-19 vac­cines on Tues­day, with the re­lease of da­ta on Mod­er­na’s vac­cine.

EMA & @Gov­Can­Health pub­lished #Clin­i­cal­Da­ta used to sup­port their au­tho­ri­sa­tions of Mod­er­na Spike­vax #Covid­Vac­cine for ado­les­cents aged 12 to 17.
Read more: https://t.co/ZGZ3nrKF9W
We are the first reg­u­la­to­ry au­thor­i­ties world­wide to pro­vide such broad ac­cess to clin­i­cal da­ta.

— EU Med­i­cines Agency (@EMA_News) Jan­u­ary 25, 2022

The EMA pre­vi­ous­ly re­leased da­ta on the Covid vac­cines from Pfiz­er/BioN­Tech, J&J, As­traZeneca, and Gilead’s Covid treat­ment remde­sivir.

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.