India likely to get Oxford COVID vaccine shots by January-February, Oxford Vaccine 70.4% effective
As per the interim phase 3 trial data, the Oxford COVID-19 vaccine is highly effective in preventing COVID-19 and offers a high level of protection against the virus.
India is likely to get the first lot of Oxford COVID-19 vaccine shots by late January or early February. This may happen as India plans to give Serum Institute of India emergency use authorisation approval for the Oxford-AstraZeneca vaccine candidate as soon as it gets similar approval in the United Kingdom.
Serum Institute of India's CEO Adar Poonawalla had stated recently that the first batch of Oxford-Astrazeneca vaccine will be made available by February 2021 for healthcare workers and vulnerable and elderly people.
He had also confirmed that the Serum Institute will apply for an emergency use authorisation in India when the UK authorities and the European Medicines Evaluation Agency (EMEA) give a go-ahead. The emergency use will, however, be limited to the frontline workers, healthcare workers, doctors, nurses, municipal staff and elderly people aged above 65 years.
Oxford Vaccine Efficacy
•As per the interim phase 3 trial data released on November 23, 2020 by the University of Oxford, the Oxford-AstraZeneca COVID-19 vaccine is highly effective in preventing COVID-19 and offers a high level of protection against the virus.
•The Oxford vaccine trials were conducted on more than 20,000 people across the world and interim data shows the vaccine to be 70.4 percent effective when participants receive half dose of the vaccine and 90 percent effective when they receive normal dose.
•The phase 3 interim analysis data indicated that the vaccine is 70.4% effective when combining data from two dosing regimens, as the vaccine efficacy was 90% in one and 62% in the other.
•The higher efficacy regimen used a halved first dose and standard second dose. As per initial analysis, the vaccine could reduce virus transmission from an observed reduction in asymptomatic infections and shows protection against hospitalisation and severe disease.
•Further, there were no severe or hospitalised cases in anyone who received the vaccine.
•The Oxford University now plans to supply their vaccine globally in partnership with AstraZeneca and other collaborators. Their aim is to supply three billion doses during 2021.
•Serum Institute CEO Adar Poonawalla tweeted saying that he is delighted to hear that, Covishield, a low-cost, logistically manageable and soon to be widely available COVID-19 vaccine will offer protection up to 90% in one type of dosage regime and 62% in the other dosage regime. He said that further details will be provided on this later.
Oxford Vaccine Storage
The Oxford-AstraZeneca COVID-19 vaccine can be stored in at fridge temperature (2-8 °C) rather than a freezer. This will make it easier to deliver the vaccine across the world and administer it in existing healthcare settings.
When will SII apply or emergency use of the Oxford Vaccine?
The Serum Institute is likely to apply for emergency use of the Oxford COVID vaccine in December. The central government is currently finalising its contract with the vaccine manufacturers for the procurement of doses.
Who will benefit from the first lot of vaccine doses?
Almost 50-60 crore vaccine doses will be required to vaccinate 25-30 crore priority population categorised into four different groups. Hence, the initial limited stock of the vaccine that is expected to come by January-end will be administered to some of the estimated 70 lakh healthcare professionals and over 2 crore frontline workers including municipal workers, armed forces and the police.
India to receive Oxford Vaccine at half rate?
India is likely to get the Oxford-Astrazeneca COVID vaccine at almost half the rate, as it will be making bulk purchases. India may get the vaccine at 50 percent of its actual MRP, which is Rs 500-600 for the two-shot vaccine.
India will be getting a price similar to the COVAX facility. The Serum Institute will be pricing the vaccine far cheaper and more affordable than other vaccines in the market today, as per SII CEO.
When will the Oxford Vaccine be available for the general public?
The SII CEO had stated that the Oxford COVID-19 vaccine should be available for the general public by April 2021. The Serum Institute has planned to manufacture about 10 crore vaccine doses per month from February 2021.
When will India's COVAXIN be considered for emergency approval?
ICMR and Bharat Biotech’s Covaxin will be considered for emergency approval after it submits data from phase I and II trials. As per sources, Bharat Biotech is in the process of publishing data for the vaccine. Currently, the vaccine is now undergoing its phase 3 trials in India.
If Bharat Biotech applies for emergency use approval after publishing its data from phase 1 and 2 trials, the regulator can consider giving it approval for emergency use considering it finds the data satisfactory. In such a case, two vaccines could be available by February.
The Serum Institute has completed the phase 3 trials of the Oxford COVID-19 vaccine in India. The Oxford AstraZeneca COVID-19 vaccine candidate has reportedly generated a strong immune response among elderly people.
The Serum Institute of India has partnered with AstraZeneca, which is developing a COVID-19 vaccine called AZD122 or ChAdOx1 nCoV-19 in partnership with Oxford University. The Serum Institute is expected to provide almost 100 million doses of the vaccine in India and other low and middle-income countries.
The Indian government is currently framing terms of references with two major bodies dealing with vaccine introduction to look into emergency use authorisation grant. The two bodies are the Central Drug Standards and Control Organisation and the National Technical Advisory Group on Immunisation.
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