With preparations for a possible vaccine rollout in January, the Indian drug regulator looks to the UK, which sources think will give a nod to the Oxford Covid-19 vaccine next week, before deciding to issue an emergency permit at the Serum Institute that manufactures the shots here.
Once the UK medicines regulator approves the Oxford vaccine, the committee of experts for Covid-19 at the CDSCO will hold its meeting and review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India thoroughly before granting an emergency permit for the vaccine here, official sources said.
The process for granting emergency approval for Bharat Biotech’s Covid-19 vaccine ‘Covaxin’ may take some time as the Phase 3 trials are still ongoing, while Pfizer is not yet to give a presentation.
“In this way, the Oxford vaccine ‘Covishield’ will likely be the first to be introduced in India,” said a source.
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Serum Institute of India (SII) had also submitted some additional data last week required by the Drug Controller General of India (DCGI), the sources said.
Amid fears of the mutated variant of SARS-CoV-2 being detected in the UK, government officials recently said it will not affect the potential of emerging vaccines being developed in India and other countries.
Bharat Biotech, Serum Institute of India (SII) and Pfizer had filed with the Drugs Controller General of India (DCGI) early this month to request an emergency permit for their Covid-19 vaccines.
The Central Drugs Standard Control Organization (CDSCO) subject matter expert committee (SEC) on Covid-19 had sought additional safety and efficacy data for Covid-19 vaccines from SII and Bharat Biotech on Dec. 9 after deliberating on their uses.
The application from the Indian arm of the American pharmaceutical company Pfizer was not considered as the company had sought more time to make a presentation before the committee.
The Pfizer vaccine has already been approved by several countries, including the UK, the US and Bahrain.
When considering SII’s filing, the SEC recommended that the company provide updated safety data from Phase 2 and 3 clinical trials in the country, immunogenicity data from the UK and India clinical trial, along with the outcome of the UK Medicines review. and Healthcare products Regulatory Agency (MHRA) for award of EUA.
As for Hyderabad-based Bharat Biotech, “the committee, after extensive deliberation, recommended that the company present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration,” the SEC had said.
Pune-based SII, the world’s largest vaccine manufacturer, has partnered with the University of Oxford and AstraZeneca to manufacture the vaccine.
The SII has already manufactured 40 million doses of the vaccine, under the DCGI’s high-risk manufacturing and storage permit, officials recently said.