The drug regulator may make a gesture with the Oxford COVID-19 vaccine next week. (Representative)
New Delhi:
With preparations underway for a possible deployment of vaccines in January, India’s drug regulator is looking to the UK, which sources believe may head the Oxford COVID-19 vaccine next week, before to decide to give emergency use permission to the Serum Institute this is to fabricate the features.
Once the UK drug regulator approves the Oxford vaccine, the COVID-19 expert committee of the Central Organization for Standard Drug Control (CDSCO) will hold its meeting and thoroughly review the data on safety and immunogenicity of clinical evaluations conducted abroad and in India before granting any emergency authorization for the vaccine here, according to official sources.
The process of granting emergency approval for Bharat Biotech’s “Covaxin” COVID-19 vaccine may take time, as its phase 3 trials are still underway, while Pfizer has yet to make any submissions. .
“Accordingly, the Oxford ‘Covishield’ vaccine is likely to be the first to be deployed in India,” a source said.
Last week, the Serum Institute of India (SII) had also submitted some additional data required by the General Controller of Drugs of India (DCGI), sources said.
Amid fears about 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 submitted an application to the Comptroller General of Drugs of India (DCGI) to apply for the emergency use of their COVID-19 vaccines. earlier this month.
On December 9, the Central Drugs Standard Control Organization’s (CDSCO) COVID-19 Expert Affairs Committee (SEC) sought additional safety and efficacy data for SII and Bharat Biotech COVID-19 vaccines after deliberation. about its applications.
The request of the Indian arm of the American pharmaceutical firm Pfizer was not taken by deliberation, 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 United Kingdom, the United States and Bahrain.
While reviewing the IBS application, the SEC had recommended that the company submit updated safety data from the Phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the United Kingdom and India, along with the outcome of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) assessment for the US grant.
As for Hyderabad-based Bharat Biotech, “after detailed deliberation, the committee recommended that the company submit safety and efficacy data from the phase 3 clinical trial in the country for further consideration. “, the SEC had said.
Pune-based SII, the world’s largest vaccine maker, has partnered with Oxford University and AstraZeneca to make the vaccine.
The SII has already manufactured 40 million doses of the vaccine, under the DCGI’s manufacturing and risk storage license, officials had recently said.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)