Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vac­cines every year with­out re­quir­ing large clin­i­cal tri­als to mea­sure their ef­fi­ca­cy, the FDA may em­ploy a sim­i­lar strat­e­gy in au­tho­riz­ing vari­ant-fo­cused ver­sions of the mR­NA vac­cines.

As the world braces for more da­ta on the lat­est vari­ant Omi­cron, which may re­duce vac­cine ef­fi­ca­cy, top vac­cine de­vel­op­ers like Mod­er­na and Pfiz­er-BioN­Tech have promised they can pull to­geth­er a new vac­cine tar­get­ed against a spe­cif­ic Covid vari­ant in about 100 days. Since Omi­cron emerged last week, Pfiz­er-BioN­Tech, Mod­er­na and J&J have all said they’ve be­gun work on Omi­cron-spe­cif­ic vac­cines, if need­ed.

Uğur Şahin

BioN­Tech CEO Uğur Şahin told End­points News in an in­ter­view re­cent­ly of the up­com­ing par­al­lels be­tween the flu and vari­ant vac­cines when it comes to FDA re­views:

We are gen­er­at­ing a dataset to get a blue­print process ap­proved — to en­sure that if a new vari­ant pops up that re­quires an adap­ta­tion of the vac­cine be­cause the orig­i­nal vac­cine doesn’t work any­more, we can just come up with a vari­ant vac­cine, and not do a large clin­i­cal tri­al. That’s what we want to ac­com­plish — like in the flu field, every time they need a new vac­cine, there’s an align­ment, this strain is not need­ed, and then you gen­er­ate a vac­cine with a lim­it­ed amount of da­ta and make this vac­cine — that’s need­ed to pre­pare for the fu­ture.

That speed from de­vel­op­ment through the reg­u­la­to­ry process may be key with Omi­cron, which has quick­ly spread to more than a dozen coun­tries across the globe, al­though it’s un­clear if this new vari­ant will al­so in­crease the num­ber of hos­pi­tal­iza­tions and deaths be­yond the hav­oc wreaked by the Delta vari­ant.

Scott Got­tlieb

For­mer FDA com­mis­sion­er and Pfiz­er board mem­ber Scott Got­tlieb ex­plained to CN­BC this morn­ing how the agency un­der­stands the gen­er­al mR­NA plat­forms now, the man­u­fac­tur­ing sites have most­ly been in­spect­ed, but what they’re look­ing for with a vari­ant-fo­cused vac­cine is “im­muno­genic­i­ty da­ta, maybe neu­tral­iza­tion stud­ies, the po­ten­tial for this new vac­cine to elic­it an­ti­bod­ies that neu­tral­ize in vit­ro, in test tubes, this new vari­ant … they won’t be look­ing for new out­comes stud­ies.”

Ja­son Schwartz, as­so­ciate pro­fes­sor at the Yale School of Pub­lic Health, ex­plained to End­points how the sec­ond ap­pen­dix in the FDA’s guid­ance on Covid-19 vac­cine EUAs spells out the agency’s think­ing.

“There they state that clin­i­cal im­muno­genic­i­ty stud­ies would be ex­pect­ed for a vari­ant-tar­get­ed vac­cine EUA,” Schwartz said via email. “But con­duct­ed just in one age group and with a post-vac­ci­na­tion pe­ri­od — mon­i­tor­ing for safe­ty — far short­er than the two months ex­pect­ed for the ini­tial vac­cines. So those could be rel­a­tive­ly small tri­als — on the or­der of a few thou­sand sub­jects, if I had to guess — with a short du­ra­tion pri­or to sub­mis­sion to FDA. Much much faster than the ini­tial round of EUAs.”

The FDA did not re­spond to a re­quest for com­ment. The agency has been in close com­mu­ni­ca­tions with Pfiz­er-BioN­Tech, Mod­er­na and J&J ex­ec­u­tives since the be­gin­ning of the pan­dem­ic and will like­ly out­line what’s re­quired for a new EUA sub­mis­sion even be­fore an­nounc­ing the de­tails pub­licly.

Mod­er­na CEO Stéphane Ban­cel al­so said on CN­BC this morn­ing that there should be more in­fo on Omi­cron’s im­pact on vac­cine ef­fi­ca­cy in about two weeks.

BioN­Tech said in a state­ment that it al­so ex­pects lab da­ta in about two weeks.

“In the event of an es­cape vari­ant, Pfiz­er and BioN­Tech are pre­pared to adapt the mR­NA vac­cine with­in 6 weeks and ship ini­tial batch­es with­in 100 days. To that end, the com­pa­nies have start­ed clin­i­cal tri­als with vari­ant-spe­cif­ic vac­cines (al­pha and delta) to col­lect safe­ty and tol­er­a­bil­i­ty da­ta that can be pro­vid­ed to reg­u­la­tors,” the com­pa­ny said.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.