Oxford Biomedica and AstraZeneca extend vaccine deal; FDA wants boosters for newer variants – Endpoints News

An Ox­ford Uni­ver­si­ty spin­out and one of the ma­jor play­ers in the phar­ma in­dus­try are ex­tend­ing their col­lab­o­ra­tion on its Covid shot.

Ox­ford Bio­med­ica and As­traZeneca on Fri­day an­nounced that they have signed a new three-year agree­ment on fu­ture man­u­fac­tur­ing for the As­traZeneca Covid-19 vac­cine. Ac­cord­ing to Ox­ford Bio­med­ica, this deal is an ex­pan­sion of the orig­i­nal agree­ment an­nounced be­tween the two com­pa­nies dur­ing the first waves of the pan­dem­ic in Sep­tem­ber 2020.

Un­der the ex­ten­sion, the man­u­fac­tur­ing of vac­cines at Ox­ford Bio­med­ica’s 84,000-square-foot fa­cil­i­ty, called Oxbox, will be avail­able to As­traZeneca on an as-need­ed ba­sis be­yond this year. The man­u­fac­tur­ing of Covid-19 vac­cines at Oxbox is ex­pect­ed to be com­plet­ed in the last quar­ter of 2022, as part of the orig­i­nal com­mit­ment.

For the batch­es that were al­ready man­u­fac­tured in the first half of 2022, it plans to have rev­enue of £30 mil­lion ($36.1 mil­lion) Ox­ford Bio­med­ica.

Roch Do­liveux

“While con­tribut­ing to the ef­forts to fight the pan­dem­ic, this has al­so demon­strat­ed Ox­ford Bio­med­ica’s abil­i­ty to ex­pand the scope of our in­no­v­a­tive process de­vel­op­ment ser­vices and de­liv­er high-per­form­ing man­u­fac­tur­ing so­lu­tions be­yond lentivi­ral vec­tors,” said Roch Do­liveux CEO of Ox­ford Bio­med­ica in a state­ment.

The orig­i­nal deal in 2020 was a five-year agree­ment to help man­u­fac­ture the Covid-19 vac­cine be­ing de­vel­oped by Ox­ford Uni­ver­si­ty’s Jen­ner In­sti­tute and As­traZeneca. The ade­n­ovi­ral vec­tor vac­cine us­es a weak­ened ver­sion of a com­mon cold-caus­ing virus to de­liv­er the gene for a coro­n­avirus in­to hu­man cells.

FDA up­dates its rec­om­men­da­tions for boost­er dos­es, ask­ing for pro­tec­tions against BA.4 and BA.5

The FDA is rec­om­mend­ing that Covid-19 boost­er shots should be up­dat­ed to pro­tect against not just the orig­i­nal Omi­cron vari­ant, but its more vir­u­lent strains.

VRB­PAC vot­ed in fa­vor of in­clud­ing an Omi­cron com­po­nent in Covid-19 vac­cines that would be used for boost­er dos­es in the US be­gin­ning in fall 2022, ad­vis­ing man­u­fac­tur­ers to up­date their shots to add a BA.4/5 spike pro­tein to cre­ate bi­va­lent boost­er vac­cines.

Out­side ex­perts that are on FDA’s ad­comm ini­tial­ly met on Tues­day to dis­cuss whether a change to the cur­rent com­po­si­tion of Covid-19 boost­ers is nec­es­sary for the fall and win­ter. While the vac­cines that have been ap­proved and au­tho­rized for emer­gency use have made a dif­fer­ence to pub­lic health and have saved lives, the virus has evolved sig­nif­i­cant­ly, with re­cent surges around at­trib­uted to vari­ants such as Omi­cron.

Pe­ter Marks, FDA

Ac­cord­ing to Pe­ter Marks, di­rec­tor of the CBER, re­sults from post-au­tho­riza­tion ob­ser­va­tion­al stud­ies have shown that the ef­fec­tive­ness of pri­ma­ry vac­ci­na­tion wanes over time against cer­tain vari­ants, in­clud­ing Omi­cron. And while ini­tial boost­er dos­es have helped re­store pro­tec­tion against se­vere dis­ease and hos­pi­tal­iza­tion as­so­ci­at­ed with Omi­cron, stud­ies have al­so in­di­cat­ed wan­ing ef­fec­tive­ness of first boost­er dos­es.

The FDA ex­pects this com­ing year to be a tran­si­tion­al pe­ri­od when the mod­i­fied boost­er vac­cine may be in­tro­duced, but the agency has not ad­vised man­u­fac­tur­ers to change the vac­cine for pri­ma­ry vac­ci­na­tion, since an ini­tial two-dose se­ries with the FDA-au­tho­rized and ap­proved vac­cines pro­vides a base lay­er of pro­tec­tion.

Glob­al reg­u­la­tors, un­der the um­brel­la of ICM­RA, al­so agreed ear­li­er this week to adapt vac­cines to tack­le the omi­cron and its sev­er­al vari­ants.

Zye­sa­mi’s EUA for Covid-19 patents is re­ject­ed 

The FDA on Fri­day re­ject­ed the EUA for Zye­sa­mi’s use for pa­tients with crit­i­cal stages of Covid-19 and who are at risk for im­me­di­ate death from res­pi­ra­to­ry fail­ure.

Ac­cord­ing to a re­lease from NRx Phar­ma­ceu­ti­cals, Zye­sa­mi, al­so known as avip­tadil, was be­ing in­ves­ti­gat­ed for use in a sub-group of pa­tients that in ad­di­tion to us­ing the drug al­so, re­ceived Remde­sivir and con­tin­ued to progress. NRx Phar­ma­ceu­ti­cals had sub­mit­ted this last EUA ap­pli­ca­tion us­ing da­ta from a post-hoc sub­group analy­sis.

“As pre­vi­ous­ly com­mu­ni­cat­ed, since the fu­til­i­ty news of the AC­TIV-3b / TESI­CO Study with ZYE­SA­MI®, our team has al­ready been high­ly fo­cused on the de­vel­op­ment of NRX-101 for bipo­lar de­pres­sion in pa­tients with Acute and Sub-Acute Sui­ci­dal­i­ty. Though dis­ap­point­ing, this de­ci­sion by the FDA is not un­ex­pect­ed, giv­en that they had al­ready re­cent­ly de­clined Break­through Ther­a­py Des­ig­na­tion for Zye­sa­mi. We will eval­u­ate the op­tions for Zye­sa­mi in Covid-19 res­pi­ra­to­ry fail­ure and oth­er lung dis­or­ders once we re­ceive the full da­ta set from the NIH,” said Robert Besthof, NRx’s in­ter­im CEO.

This is not the first time Zye­sa­mi has been looked at un­fa­vor­ably by the gov­ern­ment. In late May, there were more deaths in the treat­ment group than in the place­bo co­hort in an NIH study of Zye­sa­mi which was al­ready re­ject­ed, and the da­ta safe­ty board rec­om­mend­ed stop­ping the tri­al. In the treat­ment arm, the mor­tal­i­ty was 37% com­pared to 36% in the place­bo group.

This weight has brought down NRx’s stock price $NRXP through the floor, as it has dropped 87% since the be­gin­ning of the year.