New Delhi: The External Affairs Ministry is closely watching the developments regarding the evaluation of the World Health Organisation (WHO)’s Emergency Use Listing (EUL) of indigenous COVID-19 vaccine Covaxin, said MEA Spokesperson Arindam Bagchi on Thursday.
“We are closely following the developments regarding efforts by Bharat Biotech to obtain Emergency Use Listing authorization from the World Health Organisation, ” said Arindam Bagchi.
The External Affairs Ministry is coordinating with Bharat Biotech to secure WHO recognition for the COVID-19 vaccine. Covaxin is among three vaccines currently being administered in India against the COVID-19 pandemic.
The Hyderabad-based Bharat Biotech’s pre-submission meeting with WHO was held on June 23 for Emergency Use Listing. Earlier, last month, Bharat Biotech had informed that it had submitted 90 per cent of the documentation needed for WHO’s EUL.
The crucial meeting follows the US Food and Drug Administration (FDA) rejection for an emergency use authorization (EUA) to Covaxin on June 10, on the basis of inadequate data from clinical trials. The news was shared by Bharat Biotech’s US partner Ocugen, which stated they have decided to pursue a biologics license application (BLA) for its COVID-19 vaccine candidate, Covaxin.
On June 22, Bharat Biotech submitted the data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI), as per government sources. The data from the Phase 3 clinical trials of Bharat Biotech’s COVAXIN show that the vaccine against Covid-19 is 77.8% effective, in review by the Subject Expert Committee (SEC).
The MEA added that they are closely monitoring the process with the global health body and expressed their hope that the Covid situation in the country improves so that traveling to India becomes easier.
“We would hope as the COVID situation continues to improve in our country other countries would take steps to normalise travel with India. We have seen some initial steps in this regard, the government will continue to prioritise this issue,” Bagchi added.
The MEA spokesperson also informed that External Affairs Minister Dr S Jaishankar will leave for Greece on June 25 which is the first EAM level visit in 18 years.
“EAM Dr S Jaishankar will be leaving tomorrow for a visit to Greece and Italy. In Greece, he would make a bilateral visit on June 25 and 26 for talks with his Greek counterpart apart from other engagements. This is the first EAM level visit in 18 years,” Bagchi informed.
Indian Foreign Minister will travel to Italy the following day, Bagchi added, “After Greece, EAM will travel to Italy to attend the G20 Ministerial Meetings.”