In a key meeting today, the applications filed for emergency use of coronavirus vaccine by the Serum Institute of India, Bharat Biotech and Pfizer will be taken up for consideration by a government-appointed panel of experts.
The meeting comes a day before the dry run for vaccination will be carried out in all states.
The SII is manufacturing 'Covishield' vaccine developed by Oxford University and pharma industry major AstraZeneca. Bharat Biotech partnered with the Indian Council of Medical Research to produce 'Covaxin', and Pfizer has asked for time to present its data.
"The Subject Expert Committee (SEC) in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt. Ltd," the health ministry said in a statement.
The panel comprising of members from the Central Drugs Standard Control Organisation (CDSCO) had previously met on Wednesday to consider emergency use authorisation applications and decided to reconvene on January 1 to further deliberate on the matter.
After the expert panel gives nod to the vaccines, the applications will be reviewed by the Drugs Controller General of India for final approval.
The government is aiming to start the vaccination drive this month.
At an event on Thursday, Drugs Controller General Dr VG Somani said, "Probably we will have a happy New Year with something in hand. That is what I can hint at".
India, which has the world's second-highest number of Covid-19 infections in the world after the United States, plans to inoculate 30 crore people in the next six to eight months and the affordable Oxford vaccine is its biggest hope.
Though the Indian government has not yet signed a purchase agreement with Serum Institute, the company says it will focus on its home market first, and then exports, mainly to South Asian countries and Africa.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday approved the Covid-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has entered into a tie-up AstraZeneca to manufacture “Covishield”.
While considering SII's application, the SEC on December 9 had recommended that the firm should submit 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 MHRA for grant of EUA.
As for Hyderabad-based Bharat Biotech, after detailed deliberation, the committee had recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.
(With PTI inputs)
