Even as vac­cine man­u­fac­tur­ers plow a path to mar­ket for Omi­cron-spe­cif­ic boost­er shots this fall, NI­AID di­rec­tor An­tho­ny Fau­ci’s mes­sage is clear: “Our job is not done.”

Fau­ci, who al­so serves as chief med­ical ad­vi­sor to Pres­i­dent Joe Biden, took the White House podi­um on Tues­day to of­fer a glimpse at where next-gen­er­a­tion vac­cines are head­ed — specif­i­cal­ly high­light­ing the need for pan-coro­n­avirus can­di­dates and mu­cos­al op­tions that can be ad­min­is­tered in­tranasal­ly.

“In­no­v­a­tive ap­proach­es are clear­ly need­ed to in­duce broad and durable pro­tec­tion against coro­n­avirus­es known and un­known,” he said.

At the end of last month, the FDA rec­om­mend­ed that vac­cine man­u­fac­tur­ers like Pfiz­er and Mod­er­na move for­ward with Omi­cron-spe­cif­ic for­mu­la­tions, which may be avail­able in ear­ly- to mid-fall.

Thanks to cur­rent vac­cines, we’ve avert­ed well over two mil­lion deaths and about a tril­lion dol­lars in health­care costs, Fau­ci said. How­ev­er, vac­cine de­vel­op­ment is be­com­ing in­creas­ing­ly com­pli­cat­ed, as we’re now see­ing “sub­lin­eages of sub­lin­eages” of Covid vari­ants.

“These in­jectable vac­cines do a great job at pre­vent­ing se­vere dis­ease, but they do lit­tle to pre­vent in­fec­tion and trans­mis­sion, and trans­mis­sion is the en­gine of vari­ant evo­lu­tion,” said Mar­tin Moore, CSO and co­founder of Meis­sa Vac­cines.

Down the road, Fau­ci ad­vo­cat­ed for pan-coro­n­avirus vac­cines, or mu­cos­al op­tions that could po­ten­tial­ly stop trans­mis­sion in its tracks.

“When you have a mu­cos­al, and in this case, in­tranasal, what you do is you stim­u­late at the lo­cal lev­el,” Fau­ci said dur­ing the sum­mit, which was broad­cast live on Zoom. “The goal of that is not on­ly to pro­tect against dis­ease, but to pro­tect against ac­qui­si­tion and by ac­qui­si­tion, trans­mis­sion. And that’s re­al­ly the holy grail.”

Akiko Iwasa­ki

Cur­rent vac­cines in­duce ro­bust sys­temic im­mune re­spons­es, but do not in­duce a mu­cos­al re­sponse, ac­cord­ing to Akiko Iwasa­ki, an im­munol­o­gy pro­fes­sor at Yale Uni­ver­si­ty. She’s al­so the co-founder of Xanadu Bio, a Yale spin­out look­ing to bring an in­tranasal Covid can­di­date in­to the clin­ic. Mu­cos­al vac­cines are de­signed to pre­vent a virus from ever get­ting to a host cell, like putting a guard out­side your house to pro­tect from in­vaders, Iwasa­ki said.

Iwasa­ki re­cent­ly co-au­thored a pa­per in Sci­ence Im­munol­o­gy along­side Scripps Re­search Trans­la­tion­al In­sti­tute founder Er­ic Topol that ad­vo­cates for an ac­cel­er­at­ed ini­tia­tive for in­tranasal Covid-19 vac­cines, sim­i­lar to Op­er­a­tion Warp Speed.

“We know from 200 years of vac­ci­nol­o­gy … that vac­cines that mim­ic nat­ur­al in­fec­tion tend to work best,” Moore said. “No one here to­day can tell you that mu­cos­al COVID vac­cines work, we’re not there yet. We need clin­i­cal ef­fi­ca­cy da­ta to an­swer that ques­tion, and that’s why we’re here.”

Paul Bur­ton

Man­u­fac­tur­ing is al­so “a key part of the fu­ture,” Mod­er­na’s CMO Paul Bur­ton said at the sum­mit, adding that the com­pa­ny has re­cent­ly struck deals to build new plants and R&D sites in Aus­tralia, the Unit­ed King­dom, Cana­da and Kenya.

“We have to con­tin­ue these dis­cus­sions, con­tin­ue these col­lab­o­ra­tions to in­still con­fi­dence,” Bur­ton said. “Get­ting that con­fi­dence and then the abil­i­ty to get these shots made in coun­tries and in­to peo­ple’s arms I think is how we’re go­ing to con­tin­ue to get out of the pan­dem­ic.”

Pfiz­er bio­phar­ma group pres­i­dent An­gela Hwang added that the de­vel­op­ers con­tin­ue to im­ple­ment lessons learned from the pan­dem­ic to make the process more ef­fi­cient.

“Prob­a­bly two and a half bil­lion peo­ple have re­ceived the Pfiz­er vac­cine,” she said. “That’s an in­cred­i­ble wealth of re­al world ev­i­dence that we’re sit­ting on. And so I think that we have a great op­por­tu­ni­ty, hav­ing that strong depth and breadth of da­ta, to use that to al­so help us to un­der­stand, how can we de­sign new ther­a­pies?”

*A cor­rec­tion has been made to the at­tri­bu­tion of two quotes by Mar­tin Moore.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.