File image: A ground staff walks past a container kept at the Cargo Terminal 2 of Delhi's Indira Gandhi International Airport, which according to the officials will be used as a COVID-19 vaccine handling and distribution center. (Image: Reuters/Anushree Fadnavis)
An expert panel of the Central Drugs Standard Control Organisation (CDSCO) on January 1 recommended emergency use authorisation (EUA) "with conditions" for Serum Institute of India's (SII) Covishield vaccine, CNBC TV-18 reported quoting sources.
The Subject Expert Committee (SEC) has recommended in favour of the EUA approval to the Drugs Controller General of India (DCGI) for SII's Vaccine, according to the news channel. The DCGI receives recommendations from the SEC.
Sources said that the expert panel did not approve Covaxin and asked Bharat Biotech to present more data. News agency PTI reported that it also asked the company to expedite volunteer recruitment and recommended interim efficacy analysis for Covaxin.
Earlier, the Health Ministry had tweeted that a final decision will be taken by the DCGI.
The SEC on COVID-19 had on December 30 deliberated and analysed the additional data and information submitted by SII and Bharat Biotech.
SII, Bharat Biotech, and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates.
Read: COVID-19 vaccination drive: Over 70 lakh healthcare workers registered on Co-WIN platform
Dr Vinod K Paul, Head of the National COVID-19 Task Force told the news channel that broadly dosing guidelines are likely to be similar to United Kingdom (UK) approval, which is to say 4-12 weeks.
He added that there are 31 hubs to supply vaccines to all the states and that India will "pitch for 300 million individuals".
"Bharat Biotech vaccine is a very promising vaccine... Expert group will take a call with respect to its review," Paul told the news channel in an exclusive interview.
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Regarding the news of the recommendation, Dr Paul said that it's a "great day" if indeed the development has taken place.
Six vaccines are at various stages of clinical trials, of which four are being indigenously developed.
The clinical trials by Bharat Biotech are in phase 3, while the one which is being developed by Zydus Cadila is in phase 2 clinical trial.
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The government has identified priority beneficiaries of the vaccine and over 70.33 lakh frontline healthcare workers have been registered on the Co-WIN platform. The government is planning to inoculate them in the first phase of the coronavirus vaccination drive.
To vaccinate the beneficiaries, the government has also identified over 2.30 lakh vaccinators, sources told CNBC-TV18. Additionally, over 51,000 public health facilities have been shortlisted for the vaccine rollout.
A dry run for COVID-19 vaccination will be conducted by all state and Union Territory administrations on January 2 to test the linkages between planning and implementation and to identify challenges, the Centre said.
While some states will also include districts that are situated in difficult terrains/have poor logistical support, Maharashtra and Kerala are likely to schedule the dry run in major cities other than their capital, the Union Health Ministry said.
Read: Serum Institute to have 100 million COVID-19 vaccine doses ready by January first week
"The objective of the dry run for COVID-19 vaccine introduction is to assess operational feasibility in the use of Co-WIN application in the field environment, to test the linkages between planning and implementation and to identify the challenges and guideway forward prior to actual implementation. This is also expected to give confidence to programme managers at various levels," the ministry said.