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.

Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen. Kyrsten Sinema (D-AZ) reportedly pledged her support on Thursday — but will they fit it in before recess?

Sinema said she has agreed to “move forward” with the reconciliation bill with some stipulations, including the removal of a carried tax provision, according to recent reports. The bill is still expected to reduce the deficit by $300 billion, and Sen. Chuck Schumer (D-NY) said that he now anticipates “support from the entire Senate Democratic conference,” the Washington Post reported. 

With the rising number of monkeypox cases, leading researchers at the CDC, FDA and NIH are calling on a randomized clinical trial to see if an approved smallpox drug is effective at treating monkeypox.

No monkeypox treatments are approved in the US, so patients looking to get relief for their lesions and other symptoms from the virus must go through a set of hurdles to get the smallpox drug through a government expanded access program. Approved for smallpox in 2018, the drug is marketed as TPOXX by the biotech SIGA. The European Union approved it for monkeypox in addition to smallpox earlier this year and the UK followed suit in July.