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Oxford Covid-19 Vaccine May Become First To Get Clearance From Indian Regulator For Emergency Use


With preparations underway for a possible January launch of the vaccine, India’s drug regulator is looking into the UK, which sources say may give the Oxford Covid-19 vaccine its go-ahead next week, ahead of decide to grant the emergency use authorization to the Serum Institute that is manufacturing the shots here.

Once the UK drug regulator gives its approval to the Oxford vaccine, the Covid-19 expert committee at the CDSCO will hold its meeting and thoroughly review the safety and immunogenicity data from clinical evaluations conducted at the abroad and in India before granting any emergency authorization for the vaccine here, official sources said.

The process to grant emergency use approval for Bharat Biotech’s Covid-19 vaccine ‘Covaxin’ may take time as its phase 3 trials are still ongoing, while Pfizer has not yet made a submission.

“From this, it is likely that the Oxford vaccine ‘Covishield’ will be the first to be implemented in India,” said a source.

The Serum Institute of India (SII) also released some additional data required by the Comptroller General of Drugs of India (DCGI) last week, the sources said.

Amid fears over the mutated variant of SARS-CoV-2 detected in the UK, government officials recently said it will have no impact on the potential of emerging vaccines being developed in India and other countries.

Bharat Biotech, Serum Institute of India (SII) and Pfizer had applied to the Controller General of Medicines of India (DCGI) for an emergency use authorization for their Covid-19 vaccines earlier this month.

The Central Drug Control Organization (CDSCO) subject matter expert committee (SEC) on Covid-19 on Dec. 9 had sought additional safety and efficacy data for the Covid-19 IBS and Bharat Biotech vaccines after deliberate on their applications.

The application from the Indian branch of the US pharmaceutical company Pfizer was not discussed, as the company had sought more time to make a presentation to the committee.

The Pfizer vaccine has already been approved by several countries, including the UK, the US, and Bahrain.

In considering the SII application, the SEC had recommended that the company submit updated safety data from phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the result from the UK Medicines and Health Products Regulatory Agency (MHRA) assessment for the US concession.

Regarding Hyderabad-based Bharat Biotech, “after detailed deliberation, the committee recommended that the company submit the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration,” said the SEC.

The Pune-based IBS, the world’s largest vaccine manufacturer, has partnered with Oxford University and AstraZeneca to manufacture the vaccine.

IBS has already manufactured 40 million doses of the vaccine, under the DCGI’s manufacturing and storage-at-risk license, officials said recently.

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