Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
Several states and UTs including Delhi, Maharashtra, Karnataka and Telangana have decided to opt for global tenders for procurement of anti-coronavirus shots with the domestic supply falling short to meet the rising demand.
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
Microsoft Chairman and CEO Satya Nadella along with Alphabet Inc and its subsidiary Google CEO Sundararajan Pichai are also among those from trade and industry who have been awarded the Padma Bhushan for their distinguished services.
There are a number of trial sites across both Mumbai and Pune that we have shortlisted, as these cities have many hotspots, which will help us understand the efficacy of the vaccine, the company's chief executive Adar Poonawalla said.
Pawar made the remarks while replying to a question from reporters about allegations of sabotage behind the fire on Thursday.
While the vaccine could be available at $3-6 (Rs 225 to Rs 550) per dose, herd immunity might be two years away due to implementation challenges, it said, adding the experience in large scale adult vaccination programmes is thin.
Poonawalla, however, did not specify the quantity of the doses that will be kept for the community, which is grappling with a shrinking population.
On Tuesday, Rao said there was a possibility of the PM's visit to Pune, and if that happens, it would be aimed at reviewing the status of the vaccine candidate for coronavirus infection and to know about its launch, production and distribution mechanisms.
The government plans to immunise 30 million people in the first phase, starting February, and by July, the target is to vaccinate 250 million people, reports Sohini Das.
The Union government's role and the prices announced by the vaccine makers raises far too many disquieting questions, observes Prosenjit Datta.
'Once DCGI will give us the permission to restart the trials in India, we will resume the trials,' Serum Institute of India (SII) said in a statement.
As the Omicron variant of Sars-CoV-2 takes centrestage, vaccine makers in India are of the view that scaling up the existing vaccines to make them more effective is possible.
Poonawalla has been getting threats from various groups regarding the COVID-19 vaccine supplies.
The comments by a spokesperson in the British High Commission in New Delhi came amid concerns in India over the latest Covid-related travel restrictions announced by the UK.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
Laws governing compensation in case of adverse side effects for Covaxin and Covishield may differ in accordance with the kind of approvals given, say legal experts.
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.
Two male volunteers were administered the vaccine at Bharti Vidyapeeth's Medical College and Hospital, a senior office-bearer of the hospital said.
The 'terrible' surge of the coronavirus cases in India has severely impacted COVAX's vaccine supply in the second quarter of this year to the extent that there will be a shortfall of 190 million doses by the end of June, according to a joint statement by the WHO, UNICEF, GAVI and CEPI.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
A massive pan-India inoculation drive against COVID-19 was set in process on Tuesday with more than 56 lakh doses of the Covishield vaccine flown to 13 cities across India from Pune and taken to designated national and state-level stores amid tight security.
According to officials, an additional dose of vaccine is different from a booster dose.
India's first indigenously developed quadrivalent Human Papilloma Virus (HPV) vaccine for the prevention of cervical cancer will be launched in a few months and made available to the people in an affordable price range of Rs 200-400, Serum Institute of India CEO Adar Poonawalla said on Thursday.
The Centre has shared a set of parameters with all states and UTs to enable service providers and monitoring teams under the national COVID-19 vaccination programme to identify any fake COVID-19 vaccines so that they are not administered in the country.
The Indian vaccine industry largely feels there are two ways in which vaccine innovation can be spurred - one, get a high price for the product and two, have the government buy a few hundred million doses of the product at a certain price.
The DCGI said it has no objection in respect of 'Extension of Shelf Life of Covishield Vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.
According to the sources, the vaccine will be much more affordable than existing ones manufactured by two foreign companies. India's drug regulator in July had granted market approval for the Pneumococcal Polysaccharide Conjugate vaccine, after reviewing the phase 1, 2 and 3 clinical trial data submitted by the Pune-based firm.
The global trials were halted after a study participant suffered a 'potentially unexplained illness, reports Sohini Das.
The Central Drugs Standard Control Organisation has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking the number of preventives and treatments available in India to 12.
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.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.
Poonawalla noted that reducing the timeframe would give "real relief" to the people who want to travel abroad.
The Pune-based company's chief executive Adar Poonawalla said the company, which is the largest vaccine maker in the world, is putting $200 million at risk by manufacturing nearly 300 million doses before the final nod to launch the vaccine in market, which is expected at best by the end of the year.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
Prime Minister Narendra Modi is likely to announce a host of initiatives for the health sector on Independence Day with the highlights being the 'Heal in India' and 'Heal by India' projects and a roadmap to eliminate sickle cell disease by 2047, official sources said.
Indian Council of Medical Research Director General Balram Bhargava said the purpose of the COVID vaccine drive would be to break the chain of viral transmission.
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