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.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.