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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.