Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

Covid-19 roundup: Ugur Sahin says new shots like­ly need­ed for Omi­cron; UK ful­ly ap­proves Vir/Glax­o­SmithK­line an­ti­body

De­spite Ugur Sahin’s calls for calm over the Omi­cron vari­ant — mak­ing a much more mea­sured ap­peal than Mod­er­na CEO Stéphane Ban­cel — the BioN­Tech chief is al­ready pre­dict­ing the po­ten­tial need for new Covid-19 vac­cines.

In com­ments made at a con­fer­ence host­ed Fri­day morn­ing by Reuters, Sahin said that even though vac­ci­nat­ed in­di­vid­u­als would like­ly still be pro­tect­ed from se­vere dis­ease, Omi­cron could see greater num­bers of break­through in­fec­tions than oth­er vari­ants. The mu­ta­tions mean Covid shots will prob­a­bly be­come nec­es­sary every year, sim­i­lar to the flu.

“I be­lieve in prin­ci­ple at a cer­tain time point we will need a new vac­cine against this new vari­ant. The ques­tion is how ur­gent it needs to be avail­able,” Sahin said at the con­fer­ence, which was al­so re­port­ed on by Reuters.

He added that even though emerg­ing da­ta sig­nal Omi­cron is high­ly in­fec­tious, the ques­tion still re­mains whether or not it caus­es se­vere dis­ease at a high­er rate.

“It is not clear whether this vari­ant pro­duces more se­vere dis­ease,” Sahin said.

Sahin’s Fri­day com­ments come a cou­ple of days af­ter he said vac­cine-in­duced T cell re­spons­es would al­most cer­tain­ly re­main strong against Omi­cron, telling peo­ple “Don’t freak out” just yet over the vari­ant. In com­ments to the Wall Street Jour­nal, the CEO said those who re­ceived their shots — es­pe­cial­ly those that got a boost­er — would still be pro­tect­ed against hos­pi­tal­iza­tion and death.

The re­marks con­trast­ed sharply with Ban­cel, who one day pri­or had said,“This is not go­ing to be good” in an in­ter­view with the Fi­nan­cial Times. Ban­cel pre­dict­ed a sig­nif­i­cant drop in vac­cine ef­fec­tive­ness, but stressed he didn’t know how steep the drop might be.

UK reg­u­la­tors ful­ly ap­prove Vir/Glax­o­SmithK­line an­ti­body treat­ment

As the UK con­tin­ues try­ing to chart a path through a sig­nif­i­cant Covid-19 surge, the coun­try’s reg­u­la­tor ful­ly ap­proved an­oth­er tool to fight the virus.

The MHRA gave a full OK to the Vir/Glax­o­SmithK­line mon­o­clon­al an­ti­body on Fri­day, be­com­ing the sec­ond mAb treat­ment to get an ap­proval in the coun­try for use in mild-to-mod­er­ate cas­es where the pa­tient is at risk to de­vel­op se­vere Covid-19. The UK had pre­vi­ous­ly ap­proved the mon­o­clon­al an­ti­body de­vel­oped by Roche and Re­gen­eron.

“This is yet an­oth­er ther­a­peu­tic that has been shown to be ef­fec­tive at pro­tect­ing those most vul­ner­a­ble to COVID-19, and sig­nals an­oth­er sig­nif­i­cant step for­ward in our fight against this dev­as­tat­ing dis­ease,” MHRA chief June Raine said of the Vir/GSK treat­ment in a state­ment.

Reg­u­la­tors cit­ed a study show­ing a sin­gle treat­ment of the an­ti­body re­duced the risk of hos­pi­tal­iza­tion and death by 79% in pa­tients vul­ner­a­ble to se­vere Covid-19. The treat­ment had pre­vi­ous­ly won a con­di­tion­al au­tho­riza­tion in in­di­vid­u­als with mild or mod­er­ate cas­es and at least one co­mor­bid­i­ty.

The agency al­so not­ed it’s not yet known whether the Omi­cron vari­ant will have any im­pact on the drug’s ef­fec­tive­ness. Ear­li­er this week, how­ev­er, a GSK spokesper­son told End­points News it’s op­ti­mistic the an­ti­body will hold up against the new mu­ta­tion.

“Based on the se­quence of the Omi­cron vari­ant, we be­lieve sotro­vimab is like­ly to main­tain ac­tiv­i­ty and po­ten­cy against this vari­ant, and we are work­ing to con­firm this in the lab as a mat­ter of ur­gency,” the spokesper­son said, us­ing the treat­ment’s chem­i­cal name.

Al­so on Fri­day, the MHRA re­newed its au­tho­riza­tion for the Pfiz­er/BioN­Tech vac­cine, ex­act­ly one year to the day af­ter it be­came the first agency to al­low the shot’s use.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.