The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.
Poonawalla, however, did not specify the quantity of the doses that will be kept for the community, which is grappling with a shrinking population.
The New York Times on Tuesday said Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.
Serum Institute of India plans to make 300 million doses of AZD1222 by December, and will begin phase-2 trials soon. It has also tied up with Novavax for development and commercialisation of its candidate.
The Medicines and Healthcare Regulatory Agency, which had been formally tasked by the UK government last month with the process of clearance after the jab emerged "safe and effective" against the novel coronavirus in human trials, is expected to authorise the vaccine by December 28 or 29 after the final data is provided on Monday, 'The Daily Telegraph' quoted senior government sources as indicating.
The WHO said the four current 'Variants of Concern' being monitored closely - Alpha, Beta, Gamma and Delta - are widespread and have been detected in all WHO regions.
Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.
The UK government is under increasing pressure on Monday to review its COVID-19 vaccine protocol in place for travellers from India, after its updated rules effective from next month failed to recognise Indian vaccines under an expanded list of countries.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
'SII has started stockpiling the vaccine and now has roughly 40 million doses ready. It is using some of the capacities it had for under development products for the COVID-19 vaccine and by January we will have a capacity to make 100 million doses per month and a stockpile of 200 million doses.'
Pune's Serum Institute of India, the world's largest vaccine maker by volume, is placing its bets on the Oxford-AstraZeneca vaccine candidate AZD1222 with CEO Adar Poonawalla stating he would start manufacturing at personal risk.
Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.
While it is not clear whether the volunteer had received the vaccine or a placebo shot during the trial, Anvisa has refused to reveal any more information citing reasons of medical privacy, CNN reported.
"The phase-III trial of 'Covishield' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. "Around 150 to 200 volunteers will be administered the vaccine candidate dose," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe said.
Serum Institute already has two deals of 100 million each to supply the Oxford-AstraZeneca and the Novavax vaccine to Gavi-Covax at $3 per dose.
A technical advisory group of the World Health Organisation was on Tuesday reviewing data on Covaxin for the emergency use listing of India's indigenously-made vaccine and it could pronounce its decision within the next 24 hours or so, a spokesperson said.
"Pfizer's proposal would dramatically dilute AstraZeneca shareholders' exposure to our unique pipeline and would create risks around its delivery," Chairman Leif Johansson said.
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.
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.
The Serum Institute of India has stockpiled 40 mn-50 mn doses and is adding more every week. Most of these will come to India.
By January-February, it's expected to have at least 100 million doses for the Indian government, reports Sohini Das.
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.
The development comes after requests for indemnity and exemption from bridging trials have been made by Pfizer and Moderna to the Indian government.
'All the vaccines that are available in most countries, right now, are all highly effective and safe.'
The technical advisory group will now meet on November 3 for a final assessment.
Two doses of Pfizer and AstraZeneca COVID-19 vaccines generate lower levels of antibodies against the Omicron variant of coronavirus, according to a study which suggests that those previously infected or vaccinated may be at an increased risk of infection.
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.
Initial data has shown immunity triggered by the two mRNA vaccines -- Pfizer-BioNTech and Moderna -- lasts for at least six months
Poonawalla said booster vaccines have no demand as there is general lethargy among people and also because they are fed up with the pandemic.
This new trial, a single-blind, randomised Phase II trial, will enrol 300 volunteers, with up to 240 of these volunteers receiving the ChAdOx1 nCoV-19 vaccine and the remainder a control meningitis vaccine, which has been shown to be safe in children but is expected to produce similar reactions, such as a sore arm.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
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.
The Covishield maker's forte throughout the past half a century has been a combination of affordable vaccines and high volumes. Its tetanus, diphtheria and measles vaccines are known throughout the world, reports Sohini Das.
As India holds its breath for the Covid vaccination to be begin, Sudhir Bisht provides a quick checklist of what you must know about the vaccines that will be administered to citizens.
AstraZeneca on Wednesday announced that it had filed separate patent infringement actions in the United States District Court, Delaware, against seven generic drug manufacturers, which have submitted abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA) seeking marketing authorisation for Crestor.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
'We're clear Covishield is not a problem. The UK is open to travel and we're already seeing a lot of people going from India to the UK, be it tourists, business people or students,' Alex Ellis, British high commissioner to India, said.
To enable large-scale vaccine studies to take place across the UK, the aim is to get 500,000 people signed up by October, which is considered vital in the fight against coronavirus.
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.
'A good 30 per cent of people will still get infected after getting the Covishield vaccine.'
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