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.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.