Since the start of the pan­dem­ic, far more at­ten­tion has been paid to de­vel­op­ing a vac­cine than to the sticky process of ac­tu­al­ly get­ting that vac­cine, once de­vel­oped, to peo­ple.

As the first vac­cines near pos­si­ble ap­proval, though, that ques­tion is gain­ing ur­gency, and it’s pos­ing a par­tic­u­lar prob­lem for the new tech­nol­o­gy that has al­lowed some of these can­di­dates to move so quick­ly: mR­NA. To re­main sta­ble, mR­NA vac­cines have to be stored at in­cred­i­bly low tem­per­a­tures — as low as -80 de­grees Cel­sius (-112 Fahren­heit). Dis­trib­ut­ing them, ex­perts have warned, pose a ma­jor lo­gis­ti­cal chal­lenge for the US and an even greater chal­lenge to the world.

On Wednes­day, Mod­er­na al­le­vi­at­ed some of those con­cerns. At a meet­ing for Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, the now house­hold-name com­pa­ny said that its vac­cines would have to be stored long-term at -20 de­grees Cel­sius and kept in nor­mal vac­cine re­frig­er­a­tors for around 7 days. That’s still a chal­lenge, but it im­pos­es few­er de­mands than some had feared. It was al­so no­tice­ably less strict than what BioN­Tech and Pfiz­er, pre­sent­ing on the same day, said they would need for their joint­ly-de­vel­oped mR­NA vac­cine: Long-term stor­age at -70 de­grees, and on­ly 24 hours of stan­dard re­frig­er­a­tion.

The dif­fer­ences have im­pli­ca­tions both for who gets a vac­cine and when and for the in­vestor-watched race for Covid-19 mar­ket share. To­wards the end of the meet­ing, CDC med­ical of­fi­cer Kath­leen Dool­ing sketched dif­fer­ent dis­tri­b­u­tion plans de­pend­ing on if Mod­er­na’s vac­cine is ap­proved, if BioN­Tech’s is ap­proved, or if both are ap­proved. If Mod­er­na came first, it would “re­quire dili­gent vac­cine man­age­ment to min­i­mize waste,” she said. A BioN­Tech ap­proval, on the oth­er hand, would all but elim­i­nate com­mu­ni­ty clin­ics and lo­cal phar­ma­cies from the ini­tial roll­out. Health­care work­ers at “cen­tral­ized sites with ad­e­quate equip­ment and high through­put” — e.g. large, ur­ban hos­pi­tals — would take pri­or­i­ty.

Nan­cy Mes­son­nier

Pfiz­er says it has “ther­mal ship­pers” that can be stored at room tem­per­a­ture and keep the vac­cine cold for 10 days if they’re re­plen­ished with dry ice. But Nan­cy Mes­son­nier, di­rec­tor of the CDC’s Na­tion­al Cen­ter for Im­mu­niza­tion and Res­pi­ra­to­ry Dis­eases, said their ap­proach still posed sig­nif­i­cant bar­ri­ers.

“The com­plex­i­ties of this plan for vac­cine stor­age and han­dling will have ma­jor im­pact in our abil­i­ty to ef­fi­cient­ly de­liv­er the vac­cine,” Mes­son­nier said af­ter their pre­sen­ta­tion, as Reuters re­port­ed.

An­a­lysts agreed that less strin­gent re­quire­ments could give Mod­er­na an “ad­van­tage,” as SVB Leerink’s Mani Foroohar put it, but they ac­knowl­edged that ad­van­tage may be tem­po­rary or lim­it­ed. The oth­er vac­cine ap­proach­es, such as vi­ral vec­tor or re­com­bi­nant pro­tein, don’t tend to re­quire such glacial stor­age con­di­tions and will like­ly be eas­i­er to dis­trib­ute when they ar­rive.

No­vavax has said their re­com­bi­nant pro­tein can be kept in a stan­dard vac­cine re­frig­er­a­tor. End­points News has reached out to the rest of the lead­ing US-backed vac­cine com­pa­nies about their re­quire­ments, as well as to Cure­Vac, the third ma­jor com­pa­ny de­vel­op­ing an mR­NA Covid-19 vac­cine. Mer­ck, which has said it chose its Covid-19 can­di­dates to be as broad­ly dis­trib­utable as pos­si­ble, said in an email they ini­tial­ly plan to store their vi­ral vec­tor vac­cines at -70 de­grees Cel­sius but are work­ing to­ward stor­ing “at more typ­i­cal re­frig­er­a­tor con­di­tions.”

The dark­horse mR­NA vac­cine ef­fort, Sanofi-part­nered Trans­late Bio, said in May they were at­tempt­ing to come up with a for­mu­la­tion that can be stored at warmer tem­per­a­tures. But they have said lit­tle of the ef­fort since.

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).