For WHO nod, Bharat Bio has to provide trial data

Bharat Biotech will have to submit phase 3 clinical trial efficacy data of Covaxin before the World Health Organization (WHO) can consider including the jab in its list of approved Covid-19 vaccines, said WHO chief scientist Soumya Swaminathan.“Submission of phase 3 data along with data on manufacturing quality is mandatory (for emergency use listing),” Swaminathan told ET.Early this week, Bharat Biotech said its emergency use listing (EUL) application had been submitted to WHO, Geneva, and regulatory approvals are expected between July and September. The WHO EUL/PQ (prequalification) evaluation process guidance document dated May 18 posted on the WHO website said Bharat Biotech had submitted its expression of interest on April 19 and that more information is required.83051466Bharat Biotech did not respond to ET’s emailed queries.WHO approval is a prerequisite for Covaxin vaccines to be supplied to low income countries under the Covax facility. Inclusion in the EUL is also important for easy international travel of Indian citizens who have been administered Covaxin. The EU and some countries like Saudi Arabia are making taking internationally approved vaccines (cleared by WHO or the US, UK, and EU regulators) a prerequisite for entry into their countries. At present, several countries have imposed restrictions on international travel from India but this can become a thorny issue for those who have taken the Covaxin jab once these restrictions are lifted.The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality, and a risk management plan.USFDA also needs Phase 3 dataBharat Biotech has released an interim analysis of its phase 3 data, but it has not yet published full results from phase 3 study in an internationally recognised peer review journal. The Pfizer, AstraZeneca, Johnson & Johnson, Moderna and Sinopharm vaccines have so far been approved by WHO for emergency use.Meanwhile, Bharat Biotech’s US partner Ocugen also said that USFDA needs phase 3 data to review its "master file".The USFDA also recently announced that it will not grant any new emergency authorisation to Covid-19 vaccines that have not begun discussions with the regulator. "FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency," the regulator said in May.But Ocugen said Covaxin will not be disqualified. “Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s revised guidance raises any concerns about our ability to submit the EUA for Covaxin as planned,” said Ocugen chairman Dr Shankar Musunuri said.

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