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Oxford-AstraZeneca becomes the first to publish final-stage COVID-19 vaccine trial data

AstraZeneca is seeking emergency use authorisation of its vaccine from the World Health Organization (WHO).

The final-stage trial results, published in The Lancet journal, confirmed that the Oxford-AstraZeneca COVID-19 vaccine works in an average of 70 per cent of cases.

Written by Longjam Dineshwori |Published : December 9, 2020 1:53 PM IST

More than 200 vaccine candidates are in development around the world, and some are in Phase III clinical trials the final step before a vaccine is approved. A few have filed for emergency use authorization, but until yesterday (8th September) none of the drugmakers had published the final-stage trial results in any scientific journal.

On Tuesday, Oxford University and AstraZeneca, which are collaborating on a COVID-19 vaccine, published the results of their final-stage clinical trial in The Lancet. They are the first COVID-19 vaccine makers to have their trial efficacy results confirmed in a scientific paper, the Lancet said.

It is described as the first full peer-reviewed efficacy results to be published for a COVID-19 vaccine.

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Oxford COVID-19vaccine works in 70% of cases

The results of the interim analysis of four randomised controlled trials conducted in Brazil, South Africa, and the UK, confirmed that the vaccine works in an average of 70 per cent of cases.

According to the first interim safety and efficacy data, the vaccine showed efficacy of 70 4% after two doses and protection of 64 1% after at least one standard dose, against symptomatic disease, with no safety concerns.

Other coronavirus vaccine developers, including Pfizer, Moderna and Russia's Sputnik V, have released preliminary high-level results in public statements.

Pfizer and BioNTech have reported more than 90% efficacy of their COVID-19 vaccine 'BNT162b2' while Moderna has claimed that its mRNA-1273 vaccine yielded 94.5% efficacy in early results. Russia also announced that its Sputnik V vaccine, developed at the National Research Centre for Epidemiology and Microbiology, showed 92 percent effectiveness against COVID-19, based on the initial results from Phase 3 trials.

In order to receive a license from the US Food and Drug Administration and the WHO, a vaccine against the COVID-19 virus should have a minimum efficacy of 50%.

In a statement, AstraZeneca said that it is seeking emergency use authorisation of its vaccine from the World Health Organization (WHO) to speed up availability in low-income countries. If approved, it is aiming to produce up to three billion doses in 2021. It has started giving data to regulators around the world as well.

Vaccines awaiting emergency use authorization approval

The UK became the first country in the world to approve the Pfizer/BioNTech COVID-19 vaccine last week. The country began a mass vaccination programme using the same vaccine on Tuesday. It plans to dispense 800,000 doses of the Pfizer/BioNTech vaccine in the coming weeks.

In its review report released Tuesday, the US FDA noted that Pfizer/BioNTech vaccine appears to be adequately safe and effective for a limited approval, suggesting that approval is expected as early as this weekend.

Moderna is the second vaccine maker to apply for emergency use authorization in the US. The FDA will discuss the request for emergency use authorization for Pfizer's coronavirus vaccine candidate on Thursday and Moderna's vaccine candidate on December 17.

In India, three vaccine makers Pfizer, Serum Institute of India, and Bharat Biotech have filed applications with the Drugs Controller General of India (DCGI) for emergency use authorisation of their COVID-19 vaccines.

Serum Institute of India is seeking government approval for emergency use authorisation of the Oxford/AstraZeneca vaccine in India. The Pune-based firm is conducting the phase-three clinical trial of the vaccine, called Covishield in India, across the country.

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