Op­er­a­tion Warp Speed, per­haps the great­est achieve­ment of the for­mer Trump ad­min­is­tra­tion, prompt­ly de­liv­ered Covid-19 vac­cine sup­plies na­tion­wide when they be­came avail­able, thanks to col­lab­o­ra­tions be­tween HHS and the De­part­ment of De­fense, while help­ing to fund and aid the man­u­fac­ture of bil­lions of dos­es.

But since the Biden ad­min­is­tra­tion took over a year ago, act­ing FDA com­mis­sion­er Janet Wood­cock tran­si­tioned out of her role as the ther­a­peu­tics lead in Warp Speed, which has been con­vert­ed in­to a new op­er­a­tion with­out the fan­cy name (now known as the “HHS-DOD COVID-19 Coun­ter­mea­sures Ac­cel­er­a­tion Group”), and as of the start of 2022, the De­part­ment of De­fense is no longer help­ing HHS on the pro­gram.

Ac­cord­ing to a new re­port from the Gov­ern­ment Ac­count­abil­i­ty Of­fice on Thurs­day, that tran­si­tion away from DOD will be tough for the HHS, which might not be equipped to take on the Warp Speed skele­ton with­out DOD re­sources and skilled per­son­nel.

“It’s un­clear whether HHS is ready to ful­ly as­sume all re­spon­si­bil­i­ties, es­pe­cial­ly those for­mer­ly led by DOD. HHS has as­sessed its work­force ca­pa­bil­i­ties, but it hasn’t ad­dressed the loss of DOD of­fi­cials with spe­cial­ized skills,” GAO said. “More­over, HHS does not have a sched­ule that is con­sis­tent with best prac­tices to help it man­age re­main­ing vac­cine-re­lat­ed ac­tiv­i­ties.”

The HHS did not con­cur with GAO’s rec­om­men­da­tion on work­force needs, and GAO said it re­vised this rec­om­men­da­tion based on up­dat­ed in­for­ma­tion, but “main­tains that it con­tin­ues to be valid.”

Mean­while, Texas Re­pub­li­can Rep. Michael Burgess in­tro­duced a bill re­cent­ly that would in­te­grate the process be­hind Warp Speed in­to the FDA. The bill al­so calls on FDA to “col­lect in­ter­im da­ta that would al­low for par­al­lel as­sess­ments of the safe­ty and ef­fec­tive­ness of mul­ti­ple drugs and bi­o­log­i­cal prod­ucts and the par­al­lel ap­proval or li­cen­sure of mul­ti­ple drugs and bi­o­log­i­cal prod­ucts, in­clud­ing through the con­duct of con­cur­rent clin­i­cal tri­als.” — Zachary Bren­nan

Eu­rope has no plans for a fourth Covid-19 vac­cine dose 

As coun­tries de­bate whether to ad­min­is­ter a sec­ond boost­er vac­cine to bat­tle Omi­cron, the Eu­ro­pean Med­i­cines Agency re­cent­ly made clear that this is not the di­rec­tion in which it’s plan­ning to move.

The EMA an­nounced ear­li­er this week that a fourth dose is — at the mo­ment — off the ta­ble for the gen­er­al pop­u­la­tion, the agency said in a se­ries of mes­sages on Twit­ter.

EMA has not yet seen da­ta on the 4th dose. Cur­rent­ly, there is no ev­i­dence for the need of a 4th dose in the gen­er­al pop­u­la­tion with the cur­rent #COVID19vac­cines. #EMA­Press­er

— EU Med­i­cines Agency (@EMA_News) Jan­u­ary 18, 2022

The EMA did ac­qui­esce slight­ly, say­ing that it would be rea­son­able for pub­lic health au­thor­i­ties to con­sid­er giv­ing a fourth dose to those with se­vere­ly weak­ened im­mune sys­tems and who have al­ready had three dos­es of a Covid-19 vac­cine.

The agency went on to ad­dress vac­cines de­signed to tar­get the Omi­cron vari­ant.

“Ap­proval of Covid-19 vac­cines with a dif­fer­ent com­po­si­tion re­quires clin­i­cal da­ta that show a su­pe­ri­or im­mune re­sponse than the one gen­er­at­ed by the boost­ers cur­rent­ly avail­able,” the agency said.

Re­search on the ef­fec­tive­ness of a fourth dose against Omi­cron has been spot­ty. A study among health­care work­ers in Is­rael found that while the fourth dose does in­crease an im­mune re­sponse, it’s like­ly not enough to pre­vent in­fec­tion from Omi­cron, though it could boost pro­tec­tion against se­vere dis­ease. — Paul Schloess­er

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.