Coronavirus Vaccination | Oxford COVID vaccine 'Covishield' likely to be the first to get approval in India: Report
New Delhi | Jagran News Desk: Days after Union Health Dr Harsh Vardhan said that India will roll out its first COVID-19 vaccine in January, a media report has claimed that Oxford vaccine 'Covishield' will likely become the first vaccine to be rolled out in the country.
News agency PTI quoted government sources saying that if Oxford vaccine gets approval in the United Kingdom (UK) next week, then the Centre will likely give a nod to Serum Institute of India (SII) for emergency use authorisation in India.
However, the government sources told PTI that the Centre will hold a 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.
SII is one of the pharmaceutical firms in India that have applied for emergency use authorisation for their COVID-19 vaccines. The other two firms are Bharat Biotech and Pfizer.
However, the PTI report said that Bharat Biotech's COVID-19 vaccine 'Covaxin' will unlikely get a nod for emergency use approval as "its phase 3 trials are still underway" while Pfizer is yet to make a presentation.
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.
The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation as 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 the country, immunogenicity data from the clinical trial in the UK and India, 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, the world's largest vaccine manufacturer, has made a 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.
(With PTI inputs)
Posted By: Aalok Sensharma