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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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