New Delhi: Preparations are on in full swing so that the COVID-19 vaccination in India can start from January itself. Under these circumstances sources said that the Oxford COVID-19 vaccine may get the first nod of emergency use authorisation in India. Serum Institute of India (SII) is manufacturing the COVID-19 vaccines here.
The UK drug regulator has given its approval to the Oxford vaccine. So the expert committee on COVID-19 at the CDSCO will hold its meeting on the Oxford vaccine. It will thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India. Then it will grant any emergency authorisation for the vaccine here, official sources said.
The process of granting emergency use approval for Bharat Biotech’s vaccine ‘Covaxin’ may take time. This is because its phase 3 trials are still underway.
“Going by this, Oxford vaccine ‘Covishield’ is likely to be the first to be rolled out in India,” a source said Monday.
SIIlast week also had submitted some additional data required by the Drug Controller General of India (DCGI), the source informed.
There are fears about the mutated variant of SARS-CoV-2 detected in the UK. However, 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, SIIand Pfizer had applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccines early this month.
The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation. This is because the company had sought more time for making a presentation before the committee. The Pfizer vaccine has already been approved by several countries including the UK, the US, and Bahrain.
While considering SII’s application, the SEC had recommended that the firm should submit an updated safety data of phase 2 and 3 clinical trials in India. Also immunogenicity data from the clinical trial in the UK and India should also be submitted along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.
As for Hyderabad-based Bharat Biotech, ‘after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration,” the SEC had said.
The Pune-based SII is the world’s largest vaccine manufacturer. It made collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from the DCGI, officials recently had said.