The FDA’s Vac­cine and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee on Tues­day gave the thumbs up — by a vote of 19-2 — that the FDA should re­quire an Omi­cron-re­lat­ed com­po­nent in this next sea­son’s boost­er dose for Covid-19, which both Pfiz­er/BioN­Tech and Mod­er­na are hard at work on.

Wayne Maras­co

And while nei­ther boost­er will like­ly be ready to go with ad­e­quate sup­plies for all Amer­i­can adults by the be­gin­ning of the next school year, the sit­u­a­tion is still com­plex and flu­id, with CBER Di­rec­tor Pe­ter Marks telling the com­mit­tee that it’ll take com­pa­nies at least three months to ready their sup­plies for this ex­pect­ed next wave.

“Right now the crit­i­cal thing is the man­u­fac­tur­ers need to know what to put in­to their vac­cines,” Marks said. Over the com­ing months, there will be de­bate over who is most ap­pro­pri­ate for a boost­er, but it seems like most pan­elists would agree that those aged 50 or 55 and up might be el­i­gi­ble for a boost­er in the fall, Marks added. He al­so warned that half of Amer­i­cans still have not re­ceived a first boost­er, so FDA is hop­ing to con­vince peo­ple to sign on to the next boost­er cam­paign to help pre­vent an­oth­er big wave of hos­pi­tal­iza­tions and deaths. Marks said he to­tal­ly takes the point that “BA. 4 or 5 might not be cir­cu­lat­ing in the fall,” but by mov­ing to this bi­va­lent ver­sion, the US might be able to move close to what’s cir­cu­lat­ing.

Bruce Gellin

The rise of Omi­cron in late 2021 has brought with it two new sub­vari­ants, BA.4 and BA.5 more re­cent­ly, and Pfiz­er, Mod­er­na and No­vavax are de­vel­op­ing boost­er dos­es to com­bat these vari­ants and their sub­lin­eage bet­ter than their cur­rent vac­cines, which are based on the coro­n­avirus that emerged in late 2019.

Hen­ry Bern­stein

Ad­comm pan­elist Wayne Maras­co, pro­fes­sor of med­i­cine at Dana-Far­ber Can­cer In­sti­tute, vot­ed “yes” on the Omi­cron boost­er be­cause, “I think it’s im­por­tant to broad­en im­mu­ni­ty,” but adding, “I’m not sure if the da­ta are go­ing to show BA.4 or 5 peaks [in the fall]…but I was pret­ty im­pressed to­day that we can do bet­ter, and I’m not sure the mR­NA vac­cines as they have been pre­sent­ed so far are giv­ing us the best im­mu­ni­ty we can get here. This is a step in the right di­rec­tion but we need to reeval­u­ate.”

Paul Of­fit

Pan­elist Bruce Gellin, chief of pub­lic health strat­e­gy at the Rock­e­feller Foun­da­tion, said af­ter his “yes” vote that the process has been some­what sim­i­lar to the flu vac­cine se­lec­tion process but, “We weren’t asked to vote on sub­lin­eage, so we’re leav­ing that to the FDA, but we’ve heard a lot about the ‘4,5’, and I guess giv­en that, the con­ver­sa­tion be­tween FDA and WHO if the rec­om­men­da­tions are to make dif­fer­ent vac­cines. We’re go­ing to have to think through the range of for­mu­la­tions and the dif­fer­ent for­mu­la­tions of what’s in­clud­ed around the world.”

Hen­ry Bern­stein, a pe­di­a­tri­cian at Co­hen Chil­dren’s Med­ical Cen­ter, and Paul Of­fit, a pe­di­a­tri­cian at the Chil­dren’s Hos­pi­tal of Philadel­phia, both vot­ed against the in­clu­sion of an Omi­cron com­po­nent in fu­ture boost­ers. They ar­gued that there is no as­sur­ance that the cur­rent dom­i­nant vari­ant will still be the dom­i­nant vari­ant in the fall.

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”