Oxford COVID-19 vaccine may become the first to get DCGI nod for emergency use

With arrangements being made to possibly commence vaccine-rollout by next month in the country, Drugs Controller General of India  (DCGI) is considering the Oxford University vaccine 'Covishield' to initiate the vaccination drive, days after Union Health Dr Harsh Vardhan said that India will roll out its first COVID-19 vaccine in January. 

READ | COVID-19: Oxford-AstraZeneca Submit Vaccine Data In UK For Approval

News agency PTI quoted government sources saying that if the Oxford vaccine gets approval in the United Kingdom (UK) next week, then the Centre will probably show a thumbs up to Serum Institute of India (SII) for emergency use authorization in India.

Bharat Biotech's COVID-19 vaccine 'Covaxin' may take time to get approval as its phase 3 trials are still underway, while Pfizer is yet to make a presentation.

READ | Oxford-AstraZeneca Vaccine Deemed 'safe & Effective' As Phase 3 Data Gets Peer-reviewed

' 'Covishield ' likely to be the first vaccine to be rolled out in India '

"Going by this, Oxford vaccine 'Covishield' is likely to be the first to be rolled out in India,"  a source said.

The 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, SII, and Pfizer had applied to the DCGI seeking emergency use authorization for their COVID-19 vaccines early this month. The Pfizer vaccine has already been approved by several countries including the UK, the US, and Bahrain.

READ | Russia, AstraZeneca To Test Combination Of COVID-19 Shots

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.

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.

READ | AstraZeneca Acquires US Drug Developer Alexion In Massive $39 Billion Deal

(With PTI Inputs)