The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorisation for the Oxford COVID-19 vaccine 'Covishield', being manufactured by Serum Institute of India, reports said.
According to a report in CNBCTV18, the recommendation comes with certain conditions, but didn't elaborate on them.
A report in India Today said the Drug Controller General of India will take a final call on whether or not to approve the vaccine for emergency usage authorisation.
The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The SEC on COVID-19 of the CDSCO, which had earlier sought additional safety and immunogenicity data from SII, deliberated on its application seeking emergency use authorisation (EUA) for the shots on Wednesday and met again on Friday to review the matter.
Speaking to CNBC-TV18, Dr Vinod Paul, head of the National COVID-19 Task Force had earlier said that the SEC was close to a decision point on Covishield approval.
"We are definitely at an inflection point with respect to Covishield approval. SEC is to look at data from Indian trials and from other countries. We are close to a decision point on Covishield approval," Dr VK Paul, head of National COVID-19 Task Force had told CNBCTV18.
Sharing further details of the first phase of the vaccination programme, Dr Paul said that India has decided to pitch for 300 million individuals. "The immediate phase starts with a nationwide vaccination of healthcare workers. There will be 31 vaccine hubs supplying vaccines to all states. These 31 hubs will supply vaccines to 29,000 vaccination points in last-mile delivery," he said.
Dr Paul also clarified that the Govt has stated that financial resources are not a constraint to vaccinate people.
"India is currently looking at a priority group of 300 million and not the whole population. We're looking at the vaccination effort as a holistic public health response. We want to minimise deaths related to COVID-19, hence chose higher risk groups. As we move along, the stockpiling capacity will also rise. We want to ensure that the entire nation has herd immunity. The ultimate goal is to stall the spread of transmission for which wider vaccination is required," he added.
"We are on the same page with the industry. formal procurement and agreements will follow soon," he added.
SII had applied to the DCGI for EUA for Oxford COVID-19 vaccine on 6 December.
"In terms of safety, Covishield was well tolerated with respect to solicited adverse events... the majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated, according to PTI.
Besides Covishield, the SEC is also looking at the EUA application of Pfizer (filed on 4 December) and Hyderabad-based Bharat Biotech, which had sought the nod for its indigenously developed Covaxin on 7 December.
The SEC has started reviewing the EUA application for Covaxin, but is yet to take a final decision on the matter, sources told PTI.
With inputs from PTI
from Firstpost India Latest News https://ift.tt/3rLJrtS
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