Mod­er­na's bi­va­lent Omi­cron vac­cine se­cures reg­u­la­to­ry OK in UK

15 Aug 2022
endpts.com
Vaccine
Nine months af­ter Omi­cron nabbed the ti­tle of newest Covid-19 virus vari­ant, a vac­cine to bat­tle the new, more con­ta­gious vari­ant has re­ceived a reg­u­la­to­ry nod. But so far, on­ly in the UK.
Mod­er­na an­nounced Mon­day that the UK signed off on its boost­er vac­cine 1273.214, a 50 µg dose and es­sen­tial­ly a 2-in-1. Half of the vac­cine tar­gets the orig­i­nal virus strain, while the oth­er half tar­gets Omi­cron (BA.1). Mod­er­na not­ed that an ex­plorato­ry analy­sis showed a “good im­mune re­sponse” against BA.4 and BA.5, two Omi­cron sub vari­ants that have been pop­ping up more and more fre­quent­ly.
CEO Stéphane Ban­cel cel­e­brat­ed the ap­proval, not­ing in a state­ment that it “rep­re­sents the first au­tho­riza­tion of an Omi­cron-con­tain­ing bi­va­lent vac­cine.” Mod­er­na’s share price $MR­NA rose 2% af­ter the ap­proval.
Mod­er­na's bi­va­lent Omi­cron vac­cine se­cures reg­u­la­to­ry OK in UK
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Source: Endpts
June Raine
MHRA chief ex­ec­u­tive June Raine said in a sep­a­rate re­lease that the bi­va­lent vac­cine, al­so en­dorsed by the UK’s sci­en­tif­ic ad­vi­so­ry body Com­mis­sion on Hu­man Med­i­cines, is “a sharp­ened tool in our ar­moury to help pro­tect us against this dis­ease as the virus con­tin­ues to evolve.”
The ap­proval was based on a suc­cess­ful Phase II/III study that read out in June, in which the boost­er met all pri­ma­ry end­points, in­clud­ing a su­pe­ri­or an­ti­body re­sponse against Omi­cron (BA.1) when com­pared to base­line in par­tic­i­pants with­out an­ti­bod­ies. Mod­er­na ex­ecs said at the time dur­ing an in­vestor call that vac­cine dura­bil­i­ty will be some­thing the com­pa­ny is watch­ing and high­light­ed six months as a key dura­bil­i­ty point, which would get peo­ple through the win­ter months.
Mod­er­na not­ed that it has al­ready com­plet­ed reg­u­la­to­ry sub­mis­sions for the boost­er shot in Aus­tralia, Cana­da and the EU, and ex­pects to hear back on more au­tho­riza­tion de­ci­sions in a mat­ter of weeks. There was no men­tion about the boost­er’s reg­u­la­to­ry sta­tus in the US.
The new de­vel­op­ment will push oth­er Covid-19 vac­cine mak­ers in a rushed bid for sec­ond place, name­ly its Big Phar­ma com­peti­tor Pfiz­er, the oth­er mR­NA Covid vac­cine jug­ger­naut. Pfiz­er and its part­ner BioN­Tech an­nounced just last month that they launched a Phase II study to test ef­fi­ca­cy in their new and im­proved can­di­date, BNT162b5.
As for Mod­er­na, de­mand has al­ready start­ed, with the Eu­ro­pean Com­mis­sion mod­i­fy­ing its deal with the biotech to switch dos­es of Spike­vax to the new ver­sion once the EMA signs off on it. Plus, the Com­mis­sion is pur­chas­ing 15 mil­lion dos­es of the new vac­cines. The US al­so agreed to place an or­der for 66 mil­lion dos­es of the can­di­date back in Ju­ly in a con­tract worth $1.74 bil­lion.
Covid-19 roundup: De­sert­ed by Roche and plagued by set­backs, Atea march­es on; Eu­rope lines up or­der for Mod­er­na's Omi­cron boost­er
With the UK sign­ing off on it, it’s prob­a­bly just a mat­ter of time be­fore the rest of Eu­rope — and coun­tries across the At­lantic — fol­low suit.
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