Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

'Don't freak out': Ugur Sahin takes a dif­fer­ent tone on Omi­cron than his mR­NA coun­ter­part — re­ports

Where­as some pub­lic health of­fi­cials and bio­phar­ma lead­ers — in­clud­ing Mod­er­na CEO Stéphane Ban­cel — are sound­ing the alarm over the new Omi­cron coro­n­avirus vari­ant, BioN­Tech chief Ugur Sahin is press­ing a more cau­tious ap­proach.

In in­ter­views Tues­day with the Wall Street Jour­nal and Reuters, Sahin cau­tioned that lit­tle is yet known of the vari­ant’s abil­i­ty to cause se­vere Covid-19, and T cell re­spons­es among the vac­ci­nat­ed would like­ly re­main strong. Though the biotech is still con­duct­ing lab tests to de­ter­mine whether an­ti­body pro­tec­tion will be di­min­ished, Sahin isn’t press­ing the pan­ic but­ton.

“Our mes­sage is: Don’t freak out, the plan re­mains the same: Speed up the ad­min­is­tra­tion of a third boost­er shot,” Sahin told WSJ on Tues­day.

The com­ments stand in stark con­trast to an in­ter­view Ban­cel gave to the Fi­nan­cial Times ear­li­er this week, in which he pre­dict­ed a sig­nif­i­cant drop in vac­cine ef­fec­tive­ness against Omi­cron. Ban­cel hedged, not­ing he didn’t know how steep the drop would be, but stressed that “all the sci­en­tists I’ve talked to … are like, ‘This is not go­ing to be good.’”

Omi­cron has shak­en glob­al mar­kets since South African sci­en­tists first de­tect­ed the vari­ant last week, and coun­tries around the world are is­su­ing new trav­el bans in the hopes of stem­ming the tide. The vari­ant has been par­tic­u­lar­ly no­table for its high num­ber of mu­ta­tions, lead­ing to fears it may be more con­ta­gious than the Al­pha or Delta strains and in­fect vac­ci­nat­ed peo­ple more eas­i­ly.

But Sahin told WSJ he thinks those who re­ceived their shots — es­pe­cial­ly those that got a boost­er — would still be pro­tect­ed against se­vere dis­ease re­sult­ing in hos­pi­tal­iza­tion or death. The CEO high­light­ed that the shot pro­duced by BioN­Tech and Pfiz­er has large­ly low­ered se­vere dis­ease risk from oth­er vari­ants and said most Delta break­through in­fec­tions are mild.

He said the same would like­ly hold true for Omi­cron, as T cells con­tin­ue to of­fer pro­tec­tion even if the virus evades an­ti­bod­ies. The re­duc­tion in an­ti­body pro­tec­tion against Omi­cron is yet to be de­ter­mined, he told Reuters, but he is ex­pect­ing some loss against mild and mod­er­ate dis­ease.

Even so, Sahin is stay­ing calm.

“To my mind there’s no rea­son to be par­tic­u­lar­ly wor­ried. The on­ly thing that wor­ries me at the mo­ment is the fact that there are peo­ple that have not been vac­ci­nat­ed at all,” Sahin told Reuters.

While re­searchers await an­swers on on­go­ing lab tests, the virus and emerg­ing vari­ants aren’t go­ing away any time soon. The pan­dem­ic has al­ready cre­at­ed a boon for Pfiz­er and Mod­er­na, with the for­mer al­so de­vel­op­ing an an­tivi­ral pill it says is 89% ef­fec­tive in re­duc­ing se­vere dis­ease in in­fect­ed in­di­vid­u­als.

Pfiz­er al­so like­ly has a leg up on Mer­ck, an­oth­er com­pa­ny work­ing on an oral treat­ment. In an ad­comm yes­ter­day, ad­vis­ers nar­row­ly vot­ed to rec­om­mend au­tho­riz­ing the Mer­ck pill de­spite ques­tions about ef­fi­ca­cy and con­cerns over us­ing the ther­a­py in preg­nant women.

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.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.