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.
https://endpts.com/covid-19-roundup-ugur-sahin-says-new-shots-likely-needed-for-omicron-uk-fully-approves-vir-glaxosmithkline-antibody/