Oxford's COVID-19 vaccine gets expert panel's nod for emergency use in India, DCGI to take final call
New Delhi | Jagran News Desk: In a piece of good news for the Indians, an expert panel of Central Drugs Standard Control Organisation (CDSCO) is all set to grant the emergency use authorisation (EUA) to the COVID-19 vaccine developed by Oxford-AstraZeneca, COVISHIELD, which is being manufactured by the Indian vaccine maker, Serum Institute of India (SII).
The major development was reported by news agency PTI quoting sources in the government. The news came amid the key meet of the 10-member Subject Expert Committee (SEC) of the Drug Regulator for the approval of coronavirus vaccine in India.
The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. Meanwhile, the UK on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which had earlier sought additional safety and immunogenicity data from SII, deliberated on its application seeking emergency use authorisation (EUA) for the shots on Wednesday and met again on Friday to review the matter.
After SII's application, the SEC has started reviewing the EUA application by Bharat Biotech for its COVID-19 vaccine Covaxin but is yet to take a final decision on the matter, sources said.
Meanwhile, the Union Health Ministry has said that the SEC meeting is underway and the committee will make appropriate recommendations to the Drugs Controller General of India (DCGI), which will make the final decision.
"Meeting of Subject Expert Committee (SEC) of the national drug regulator is still going on. SEC will make appropriate recommendations to Drugs Controller General of India (DGCI). The final decision will be taken by the DCGI", the health ministry said.
SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7. Pfizer had applied for regulatory approval for its vaccine on December 4.
Posted By: Talibuddin Khan