India may give nod to the Oxford vaccine in India. With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
The process of granting emergency use approval for Bharat Biotech’s COVID-19 vaccine ‘Covaxin” may take time as its phase 3 trials are still underway, while Pfizer is yet to make a presentation.
“Going by this, Oxford vaccine ‘Covishield’ is likely to be the first to be rolled out in India,” a source said.
Serum Institute of India (SII) last week also had submitted some additional data required by the Drug Controller General of India (DCGI), the sources said.
Amid fears about the mutated variant of SARS-CoV-2 detected in the UK, government officials recently said that it will have no impact on the potential of emerging vaccines that are being developed in India and other countries.
Bharat Biotech, Serum Institute of India (SII) and Pfizer had applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines early this month.
The subject expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on December 9 had sought additional safety and efficacy data for COVID-19 vaccines of SII and Bharat Biotech after deliberating upon their applications.