Covid-19 roundup: Plant-based shot proves safe, 71% efficacious in PhIII; Bourla expects antiviral to launch this month

Que­bec-based Med­ica­go and its ad­ju­vant part­ner Glax­o­SmithK­line said Tues­day that their plant-based Covid-19 vac­cine can­di­date proved to be 71% ef­fi­ca­cious against all vari­ants of SARS-CoV-2 in a Phase III tri­al of more than 24,000 adults in Cana­da, the US, UK, Mex­i­co, Ar­genti­na and Brazil.

In ad­di­tion to show­ing 75% ef­fi­ca­cy against the Delta vari­ant specif­i­cal­ly, the com­pa­nies al­so said the vac­cine proved to be gen­er­al­ly safe, with no se­ri­ous ad­verse events re­port­ed and re­ac­to­genic­i­ty gen­er­al­ly be­ing mild to mod­er­ate. The re­sults mean that a reg­u­la­to­ry sub­mis­sion will be filed with Health Cana­da im­mi­nent­ly, they said.

Like its mR­NA coun­ter­parts, the Med­ica­go/GSK vac­cine is two dos­es, with each dose pro­vid­ed 21 days apart.

‘These are en­cour­ag­ing re­sults giv­en da­ta were ob­tained in an en­vi­ron­ment with no an­ces­tral virus cir­cu­lat­ing. The glob­al COVID-19 pan­dem­ic is con­tin­u­ing to show new facets with the cur­rent dom­i­nance of the Delta vari­ant, up­com­ing Omi­cron, and oth­er vari­ants like­ly to fol­low,’ Thomas Breuer, GSK’s glob­al Covid-19 ad­ju­vant­ed vac­cines lead, said in a state­ment. ‘The com­bi­na­tion of GSK’s es­tab­lished pan­dem­ic ad­ju­vant with Med­ica­go’s plant-based vac­cine tech­nol­o­gy has sig­nif­i­cant po­ten­tial to be an ef­fec­tive, re­frig­er­a­tor-sta­ble op­tion to help pro­tect peo­ple against SARS-CoV-2.’

GSK is al­so still work­ing with Sanofi and SK bio­science to de­vel­op ad­ju­vant­ed, pro­tein-based vac­cines, which are now in Phase III tri­als, as well as with Cure­Vac, to joint­ly de­vel­op a next-gen mR­NA vac­cine, with the po­ten­tial to ad­dress emerg­ing vari­ants in one vac­cine.

Pfiz­er CEO ex­pects an­tivi­ral to launch this month

In a race with Mer­ck to get an­tivi­rals to mar­ket, Pfiz­er CEO Al­bert Bourla told the Wall Street Jour­nal’s CEO Coun­cil on Tues­day that he ex­pects his com­pa­ny’s an­tivi­ral pill will hit the US mar­ket be­fore the end of this month.

Pfiz­er CEO says he ex­pects Paxlovid to be avail­able this year. He says FDA would like to see fi­nal da­ta from Pfiz­er’s study, not­ing Mer­ck­’s fi­nal num­bers “cre­at­ed a change.”

“I don’t ex­pect in our case this will be the case, and we’ll have the da­ta soon.” (In a cou­ple wks)

— Meg Tir­rell (@megtir­rell) De­cem­ber 7, 2021 Da­ta from Pfiz­er’s pill, known as Paxlovid, showed an 89% re­duc­tion in Covid-re­lat­ed hos­pi­tal­iza­tion or deaths in an in­ter­im analy­sis last month when com­pared to place­bo in pa­tients treat­ed with­in three days of symp­tom on­set. Pfiz­er al­so pre­vi­ous­ly said the US would pay $5.29 bil­lion for 10 mil­lion cours­es of the treat­ment.

Mer­ck, mean­while, nar­row­ly won the back­ing of an FDA ad­comm as pan­elists cen­tered their ques­tion­ing on the Mer­ck pill’s ef­fi­ca­cy and the cause of this drop off in pre­vent­ing hos­pi­tal­iza­tions and deaths, from 50% to 30% be­tween in­ter­im and fi­nal re­sults. Nei­ther Mer­ck nor the FDA could re­al­ly of­fer any spe­cif­ic caus­es for the de­cline.

The US has now pur­chased more than 3 mil­lion cours­es of Mer­ck’s an­tivi­ral, to be ac­quired from au­tho­riza­tion through ear­ly 2022, Mer­ck said. The con­tracts have earned Mer­ck a cool $2.2 bil­lion so far, and there are two mil­lion cours­es avail­able through fur­ther op­tions.
https://endpts.com/covid-19-roundup-plant-based-shot-proves-safe-71-efficacious-in-phiii-bourla-expects-antiviral-to-launch-this-month/