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

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

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.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the ‘great majority’ of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines ‘fair access.’

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Looking at past test samples, Dutch officials have detected the Omicron variant in cases dating back as far as Nov. 19, adding further evidence that the variant arrived in Europe well before the first cases were detected in South Africa.

The samples in question were taken on Nov. 19 and 23, according to the country’s health institute, RIVM.

‘It is not yet clear whether these people had also visited southern Africa,’ the RIVM said in a statement.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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Philip Dormitzer, new GSK global head of vaccines R&D

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.
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