The vaccine, currently being evaluated by Britain's independent medicines regulator, provides "100 percent protection" against severe Covid disease requiring hospitalisation, Pascal Soriot said in an interview with the Sunday Times newspaper.
Covid-19 vaccine being developed by British-Swedish pharmaceutical firm AstraZeneca and Oxford University produced a strong immune response in older adults, raising hopes that it can protect the age groups most at risk from the virus.Oxford Covid vaccine shows strong immune response in older adults
In a statement Tuesday, the EU regulator said it has received a request for the vaccine to be green-lighted under an expedited process and that it could be approved by Jan. 29 during an EMA meeting, "provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete."
The vaccine is "safe and effective", according to data published by The Lancet medical journal on December 8, with only one of the of the 23,754 volunteers who participated in the trials experiencing "possibly-related severe side effects".
Regulatory endorsement is a welcome boost for AstraZeneca and the Oxford team, which have been accused of a lack of clarity about the results from late-stage trials.of the new variant but expect that their shots will be effective against it.
The vaccine, which is being produced by bio-pharmaceutical giant AstraZeneca and also has a tie-up with the Serum Institute of India, is being evaluated by the UK's independent Medicines and Healthcare products Regulatory Agency (MHRA) after the final cut of data was submitted by the government last Monday.
“India’s drug regulator is in touch with UK drug authorities on the approval progress of the AZ/Oxford vaccine trial,” Vinod Paul, head of the Vaccine Task Force Committee, said on December 12 at a meeting organised by Ficci.
The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said.Covid-19: Serum Institute seeks emergency authorisation for Oxford vaccine Covishield in India
A day earlier, the Indian arm of US pharmaceutical giant Pfizer became the first to seek a similar approval from India's drug regulator for its own COVID-19 vaccine in the country, after securing such clearance in the UK and Bahrain.
The regulator had issued a show cause notice to SII on Wednesday evening asking it to explain why trials shouldn’t be suspended. SII had said earlier that it would be continuing with trials despite the global halt.
The coronavirus vaccine developed by Oxford University and AstraZeneca shows promise as it can generate both antibodies and cell-mediated immune responses, say several scientists in India and abroad, while cautioning that there is still a long way to go.
The phase 2 and phase 3 trials of the Covid 19 vaccine developed by the University of Oxford is all set to start in India, according to a report of news wire agency ANI. Indian pharmaceutical giant Serum Institute of India has initiated the trials to evaluate the safety and immune response of coronavirus vaccine candidate on healthy Indian adults after the pharma company got approval from Drugs Controller General of India (DCGI) earlier this month.
The Oxford Vaccine Group's director, Andrew Pollard, said in a media briefing there were "lots of cases" of infections in its Phase III trial in Britain, Brazil and South Africa.
The findings published in ‘Lancet' on Thursday based on 560 healthy adult volunteers shows that the ChAdOx1 nCoV-19 vaccine is “safe and well-tolerated” with a lower reactogenicity profile in older adults than in younger adults, meaning the older age groups could build immunity to the disease.
"I would not imagine that either developers can submit for approval in all regulatory authorities at the same time, or that all regulatory authorities will take the same time for approval," Oxford's Andrew Pollard told lawmakers.
"I'm optimistic that we could reach that point before the end of this year," chief trial investigator for the vaccine, Andrew Pollard said of presenting trial results this year. Asked if the vaccine would be ready by Christmas he said: "There is a small chance."
The Pune-based company is conducting phase-3 trials of the Oxford Covid-19 vaccine in India as part of international trials.
Serum Institute of India seeks DCGI permission for phase 2/3 clinical trials of Oxford's COVID 'vaccine'
The sources told that the Pune-based drug firm submitted its application to the DCGI on Friday seeking permission for conducting the trials of 'Covidshield'.
As the Oxford-AstraZeneca's COVID-19 vaccine gains momentum after showing positive results in the initial trials, Serum Institute of India, headed by Adar Poonawalla is all set to conduct trials for the vaccine in India, and begin production of the doses as well. In an exclusive conversation with TIMES NOW's Swati Joshi, Adar Poonawalla talked about Oxford COVID-19 vaccine, its effectiveness and availability, Bharat Biotech-ICMR controversy and more. Listen-in!!!Oxford COVID vaccine likely to hit Indian market by early 2021: Serum Institute's CEO Poonawalla
Pharma giant AstraZeneca on Saturday said that the clinical trials for their Oxford Covid vaccine have resumed in the UK following confirmation by the Medicines Health Regulatory Authority that the trials were safe.
The Drugs Controller General of India, Dr V G Somani, in his show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.
Two male volunteers were administered the vaccine at Bharti Vidyapeeth's Medical College and Hospital, a senior office-bearer of the hospital said.
The observer-blind, randomised controlled study to determine the safety and immunogenicity of ''Covishield'' on healthy Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune. Serum Institute has partnered with British-Swedish pharma company for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.
It is believed that the two local candidates — which are in early stages of human trials — will enter the market with a lag of a few weeks as compared to the Oxford candidate.