The drug regulator may nod to the Oxford COVID-19 vaccine next week. (Representative)
New Delhi:
With ongoing preparations for a possible vaccine launch by January, the Indian Drug Regulatory Authority is looking to the UK, which sources believe could shake up the Oxford COVID-19 vaccine next week, before decides on the granting of the emergency use permit to the Serum Institute, ie the manufacture of photographs.
Once the UK Drug Regulatory Authority approves the Oxford vaccine, the COVID-19 Expert Committee on the Central Drug Control Organization (CDSCO) will hold its meeting and carefully analyze the safety and immunogenicity data in clinical evaluations. conducted abroad in India before granting any emergency permit for the vaccine here, official sources said.
The process of granting emergency approval for the use of Bharat Biotech’s COVID-19 “Covaxin” vaccine may take a long time, as phase 3 studies are still ongoing, while Pfizer has not yet made a presentation.
“Next, the Oxford ‘Covishield’ vaccine will probably be the first to be launched in India,” a source said.
The Serum Institute of India (SII) also last week sent some additional data requested by the Comptroller General of Drugs of India (DCGI), sources said.
Amid fears over the mutant variant of SARS-CoV-2 detected in the UK, government officials recently said it would have no impact on the potential for emerging vaccines to be developed in India and other countries.
Bharat Biotech, the Serum Institute of India (SII) and Pfizer applied to the Comptroller General of India (DCGI) for an emergency use authorization for their COVID-19 vaccines earlier this month.
The Central Committee for the Control of Drug Standards (CDSCO) on the COVID-19 Expert Committee (SEC) on 9 December sought additional safety and efficacy data for SII and Bharat Biotech COVID-19 vaccines after deliberating on their requests. .
The request by the Indian arm of the American pharmaceutical company Pfizer was not taken for deliberation, as the company sought more time to make a presentation to the committee.
The Pfizer vaccine has already been approved by several countries, including the United Kingdom, the United States and Bahrain.
While reviewing the SII application, the SEC recommended that the company submit updated safety data from Phase 2 and 3 clinical trials in the country, immunogenicity data from clinical trials in the UK and India, together with the outcome of the Medicines Regulatory Agency assessment. and UK medical products (MHRA) for the award of EUA.
As for Hyderabad-based Bharat Biotech, “after detailed deliberation, the committee recommended that the company present safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further analysis,” the SEC said.
SII, based in Pune, the world’s largest vaccine manufacturer, has partnered with Oxford University and AstraZeneca to make the vaccine.
SII has already manufactured 40 million doses of the vaccine, under a manufacturing and risk storage license from DCGI, officials said recently.
(Except for the title, this story was not edited by NDTV staff and is published in a syndicated stream.)