Manufacturing problems trigger another clinical hold for troubled Covid-19 vaccine — latest in a string of roadblocks - Endpoints News

Just days af­ter the World Health Or­ga­ni­za­tion sus­pend­ed the use of Co­v­ax­in af­ter a man­u­fac­tur­ing site failed an in­spec­tion, the FDA has fol­lowed up with a clin­i­cal hold on the Covid-19 vac­cine’s US co-de­vel­op­er.

De­tails are in short sup­ply, but the man­u­fac­tur­ing site run by Bharat Biotech in In­dia is at the cen­ter of the is­sue af­ter be­ing cit­ed for “de­fi­cien­cies.” On Tues­day morn­ing, Bharat Biotech’s part­ner Ocu­gen re­port­ed US reg­u­la­tors had placed a hold on the shot’s Phase II/III study. Bharat Biotech de­vel­oped the shot and li­censed it to Ocu­gen to co-de­vel­op it in the US and Cana­da.

At the start of April, the World Health Or­ga­ni­za­tion sus­pend­ed its sup­ply of Co­v­ax­in, known in the US as BBV-152, through the Unit­ed Na­tions, af­ter in­spec­tors took is­sue with the In­di­an man­u­fac­tur­ing fa­cil­i­ties of Bharat Biotech.

“This is a re­sult of the com­pa­ny’s de­ci­sion to vol­un­tar­i­ly im­ple­ment a tem­po­rary pause in dos­ing par­tic­i­pants of OCU-002 while it eval­u­ates state­ments made by the World Health Or­ga­ni­za­tion fol­low­ing their in­spec­tion of Bharat Biotech In­ter­na­tion­al Lim­it­ed’s man­u­fac­tur­ing fa­cil­i­ty,” Ocu­gen said in a state­ment. “We will work with the FDA to ad­dress any ques­tions.”

An in­ac­ti­vat­ed virus-based vac­cine, Co­v­ax­in has been in use in In­dia since ear­ly 2021. It’s al­so been au­tho­rized in about a dozen oth­er coun­tries — and the WHO en­dorsed it for emer­gency use late last year. Based on Phase III da­ta from In­dia, un­veiled in June, the shot was al­most 78% ef­fec­tive at pre­vent­ing dis­ease.

Ocu­gen has long planned a Phase II/III im­muno­bridg­ing and boost­er tri­al in the US in or­der to bring it state­side. But in No­vem­ber, the FDA is­sued a clin­i­cal hold on the IND, with few de­tails re­leased. That was lift­ed in Feb­ru­ary.

It al­so sub­mit­ted a re­quest to the FDA for emer­gency use in chil­dren above the age of 2 in No­vem­ber, but the re­quest was de­nied in March.

But just a few days ago, the WHO sus­pend­ed the sup­ply of Co­v­ax­in from the UN un­til “ap­pro­pri­ate ac­tions” were tak­en to ad­dress man­u­fac­tur­ing prac­tices that weren’t up to code with cur­rent GMP stan­dards. The WHO did clar­i­fy that there were no safe­ty or ef­fi­ca­cy is­sues with the vac­cine.

That an­nounce­ment fol­lowed just a day af­ter Bharat said it would scale back pro­duc­tion of the vac­cine, fol­low­ing a de­crease in de­mand that co­in­cid­ed with a re­duced num­ber of in­fec­tions and hos­pi­tal­ized pa­tients.

Bharat had al­ready turned to oth­er vac­cine mak­ers — such as an­i­mal vac­cine mak­er Hes­ter Bio­sciences — to help ramp up pro­duc­tion at the start of its ef­forts.

Ocu­gen’s stock $OCGN sank 9% on the news in No­vem­ber, but bounced back al­most 7% in pre-mar­ket trad­ing days lat­er.

Shares were trad­ing around $2.72 Tues­day morn­ing, down about $1 from about a month ago. That’s a far cry away from the high of $15.67 in which it was trad­ing be­fore the first clin­i­cal hold in No­vem­ber.

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