Of late US regulator Food and Drug Administration denied Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin and suggested the makers to apply for full authorisation of the vaccine. In this regard, Paul stated that the detail data of the trial results will be published in a peer-reviewed journal, “go beyond”, submitted to Central Drugs Standard Control Organisation (CDSCO).
Publication of pivotal stage 3 preliminary information of Bharat Biotech’s Covaxin, which will elaborate the efficacy and validity of the native Covid vaccine created by ICMR and Bharat Biotech, will be done in the following “7-8 days”, as per Dr V K Paul, the project head of country’s Covid team.
The declaration went ahead the day the US FDA suggested that Covaxin producers apply for full authorisation as opposed to looking for EUA, consequently postponing the launch of the inoculation in that country.
On Covaxin’s phase 3 data, he said they have compiled so much safety data on phase 3 trial that has been screened by them and also examined by the regulator.
On the US decision, Paul said: “Every country’s regulatory system is different; although some aspects could be the same. The countries have their own parameters and we respect them”.