Novavax pulls out of Covid-19 vaccine alliance with Gavi – Endpoints News

No­vavax is pulling out of its Covid-19 vac­cine deal with Gavi, the Vac­cine Al­liance, a glob­al part­ner­ship tasked with en­sur­ing vac­cine ac­cess in low­er-in­come coun­tries, fol­low­ing an al­leged con­tract vi­o­la­tion.

The Mary­land-based com­pa­ny claimed on Fri­day that Gavi failed to pur­chase at least 350 mil­lion dos­es of its pro­tein-based vac­cine Nu­vax­ovid by the end of the year, per an ad­vanced pur­chase agree­ment. Gavi, the World Health Or­ga­ni­za­tion and the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) are co-lead­ers of CO­V­AX, an ef­fort to en­sure that all par­tic­i­pat­ing coun­tries, re­gard­less of in­come lev­els, have ac­cess to vac­cines.

Gavi paid No­vavax $350 mil­lion last year and an­oth­er $350 mil­lion in ear­ly 2022 as part of the agree­ment, ac­cord­ing to the com­pa­ny’s Q1 re­port. How­ev­er, No­vavax said it has on­ly re­ceived or­ders for 2 mil­lion dos­es from Gavi this year.

While Gavi was not im­me­di­ate­ly avail­able for com­ment, the or­ga­ni­za­tion has re­port­ed­ly de­nied a breach of con­tract. A spokesper­son told Reuters on Tues­day that “it is clear that No­vavax will not be able to meet its com­mit­ment to man­u­fac­ture” the dos­es un­der agree­ment by the end of the year.

“No­vavax has been ready to meet our com­mit­ment to man­u­fac­ture and de­liv­er dos­es for the CO­V­AX fa­cil­i­ty. Giv­en that vac­ci­na­tion rates in de­vel­op­ing coun­tries re­main be­low tar­gets set by pub­lic health au­thor­i­ties, our hope was that the No­vavax vac­cine might help to di­ver­si­fy the avail­able CO­V­AX vac­cine port­fo­lio and of­fer an abil­i­ty to ad­dress key lo­gis­ti­cal and up­take chal­lenges through our vac­cine’s re­frig­er­a­tor sta­bil­i­ty and more tra­di­tion­al vac­cine tech­nol­o­gy,” a No­vavax spokesper­son said in a state­ment on Tues­day.

No­vavax said on Fri­day that it gave a writ­ten no­tice to Gavi ter­mi­nat­ing the deal, “ef­fec­tive im­me­di­ate­ly.” The spokesper­son said No­vavax “val­ues its re­la­tion­ship with Gavi” and hopes to ne­go­ti­ate a new agree­ment.

The com­pa­ny’s stock $NVAX was down more than 12% on Tues­day af­ter­noon, trad­ing at around $16.56 per share.

The news comes as Nu­vax­ovid sales num­bers con­tin­ue to dis­ap­point, lead­ing CEO Stan­ley Er­ck to low­er his full-year sales guid­ance the last two quar­ters. The vac­cine won FDA au­tho­riza­tion back in Ju­ly, be­com­ing the first pro­tein-based Covid vac­cine in the US, af­ter suf­fer­ing de­lay af­ter de­lay for its EUA fil­ing. It’s al­so on the WHO’s emer­gency use list, and won au­tho­riza­tions as a boost­er this month in Cana­da and the UK.

The vac­cine raked in $626 mil­lion last quar­ter, though Er­ck low­ered his full-year sales ex­pec­ta­tions to $2 bil­lion, the low­er end of a $2 bil­lion to $2.3 bil­lion range pro­ject­ed in Q2.

Dur­ing the com­pa­ny’s Q2 call, Er­ck told in­vestors and an­a­lysts that low­er-than-ex­pect­ed de­mand from CO­V­AX con­tributed to his low­er­ing of full-year sales guid­ance.

“Glob­al­ly and par­tic­u­lar­ly with re­spect to CO­V­AX, there was a surge of sup­ply and when cou­pled with chal­lenges CO­V­AX had with the dis­tri­b­u­tion in­to low- and mid­dle-in­come coun­tries, this lim­it­ed the need for them to or­der con­tract­ed prod­uct from us and oth­er vac­cine man­u­fac­tur­ers,” he said.

While the Ac­cess to Med­i­cine Foun­da­tion not­ed “in­dus­try-wide” progress in its lat­est bi­en­ni­al re­port, the or­ga­ni­za­tion re­port­ed that low-in­come coun­tries re­main “wide­ly over­looked” when it comes to drug and vac­cine ac­cess.

“If the pan­dem­ic is to be a turn­ing point in the fight for eq­ui­table ac­cess to med­i­cine, com­pa­nies must now scale their ef­forts to cov­er more prod­ucts in their port­fo­lios, and in a greater num­ber of coun­tries,” the foun­da­tion said in a news re­lease.