Bharat Biotech para US te clinical trials koribo

New Delhi: Covid-19 vaccine bonai thaka company Bharat Biotech para janaishe ke, United States te marketing application Covaxin support koribo nemite clinical trials soruh hoboli ase koishe. “itya dak te data toh efficacy aro safety ase aro Covaxin’s Phase III trial toh loboli ase. Company para Phase III trials data toh public logot joldi janai thiboli ase, koikena Bharat Biotech para koishe. Olop thiri hoi jowa te, Bharat Biotech’s COVID-19 vaccine Covaxin, US Food & Drug Administration para Ocugen Inc”recommended” korishe, etu toh US partner aro Indian vaccine maker melaikena Biologics Licence Application (BLA) route aro additional data, nixinghopes of Emergency Use Authorisation hoboli janaishe. Thursday din Ocugen para statement te junaishe ke, FDA para recommended kora nemite biologics licence application (BLA) for Covaxin toh submit koriboli ase. BLA toh FDA for drugs & vaccines para “full approval” thikena ase. “company para itya toh Emergency Use Authorization (EUA) Covaxin toh trail nalobo. FDA para Master File nemite Ocugen logot feedback thishe koishe. Company para olop din akhe te Ocugen recommended korikena EUA application nahoikena BLA submission kora te vaccine candidate nemite extra information aro data mabkishe,” koikena Ocugen para koishe.