The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
50 lakh doses of 'Covishield' vaccine earmarked by the Serum Institute for export to the United Kingdom have now been made available for the inoculation of 18-44 age group in 21 states/UTs in India, amid a surge in COVID-19 cases, official sources said.
The Hyderabad-based Bharat Biotech has fixed the price of its COVID-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals. The Pune-based Serum Institute of India, the world's largest vaccine maker in terms of volume, has announced a price of Rs 400 per dose for its COVID-19 vaccine, 'Covishield', for state governments and Rs 600 per dose for private hospitals.
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
Millions of people across the country stayed indoors on March 22, 2020 in an unprecedented and overwhelming response to Prime Minister Narendra Modi's appeal for the nationwide curfew. People used to come out briefly at 5 pm to show their gratitude to healthcare and other essential service providers with sounds of bells, conches and claps.
While some states are carrying out vaccination twice a week some others are carrying out four or more than four times a week.
The Centre on Wednesday placed a second purchase order with the Serum Institute of India for the supply of one crore doses of Oxford-AstraZeneca COVID-19 vaccine 'Covishield', each costing Rs 210, including GST, sources said.
In a letter to all states and Union territories, the ministry highlighted that under the emergency use authorisation, coronavirus vaccination is indicated only for 18 years and above. If required, COVID-19 vaccine and other vaccines should be separated by an interval of at least 14 days.
According to the purchase order placed on Monday, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
Dispatch of the vaccine is likely to start by early Tuesday morning, sources said. According to the order placed, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
A number of European countries have banned flights from the UK as the British government warned that the potent new strain of the virus was "out of control" and imposed a stringent new stay-at-home lockdown from Sunday.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
According to the health ministry, the block task force would be tasked with resolving bottlenecks, thus de-centralising planning and preparedness for vaccine introduction.
Five vaccine candidates are in advanced stages of development in India, out of which four are in Phase II/III and one is in Phase-I/II trials.
In a letter to states and union territories, Union Health Secretary Rajesh Bhushan has suggested setting up of a state steering committee chaired by the chief secretary, a state task force led by additional Chief Secretary or principal secretary (health), and a district task force to be headed by the district magistrate.
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