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UK likely to approve Oxford Covid vaccine by year-end, may help boost its chances in India

The trials for the vaccine in India are being carried out by Serum Institute of India (SII) and the company has applied for its emergency authorisation use.

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New Delhi: After becoming the first country to approve and roll out Pfizer’s Covid vaccines, the United Kingdom may also approve Oxford University’s vaccine before the end of this year, a report published by The Telegraph said. This move, in turn, may boost the vaccine candidate’s chances of getting the necessary approvals in India.

UK has already begun the first Covid-19 vaccination programme in the world, with vaccine shots of the Pfizer/BioNTech product given to elderly people and healthcare workers.

According to the report, “Senior Whitehall sources believe the Medicines and Healthcare Regulatory Agency (MHRA) will authorise the (Oxford University) vaccines on December 28 or 29 after final data is provided to the regulator on Monday.”

MHRA is the health agency of the UK, which is responsible for ensuring the availability of safe and efficacious medicines, medical devices and vaccines in the country.

“The Oxford vaccine is expected to be approved within days of Christmas, kickstarting a massive drive to give jabs to millions of people in January,” the report said.

The approval, the report claims, can work as a game-changer as the Oxford vaccine can be transported and administered “far more easily”. This is because it can be stored in regular refrigerators, unlike Pfizer’s product, which requires ultra cold conditions.


Also read: Covid spread like wildfire due to lack of implementation of guidelines — SC


May help with approval in India

The trials for the vaccine in India are being carried out by the Pune-based Serum Institute of India (SII) at multiple sites and the company has also applied for its emergency authorisation use. The application was reviewed by the Indian regulator and is pending for approval.

If the UK approves the product, it may help the vaccine candidate receive approval from Indian regulators as well.

While Adar Poonawalla, CEO of SII, refused to comment on the development, another official at the firm told ThePrint that “the approval from MHRA will certainly bring confidence among drug regulators here.”

A government official at the country’s apex health regulatory agency, Central Drugs Standard Control Organisation(CDSCO), told ThePrint that “we will definitely consider the data points which MHRA will take into the consideration for approving the Oxford vaccine”. “The UK’s move will definitely infuse confidence among people to accept the company’s vaccination shots, once approved by CDSCO,” the official, who did not wish to be identified, added.

However, he said that the process of approval will not be hastened. “It won’t impact the timeline of approval. Pfizer is already approved by the UK government but India is taking its own time for authorisation,” he said.

However, according to Dr Anant Bhan, doctor and researcher in the fields of global health, health policy and bioethics, it’s likely that the possibility of the UK MHRA providing approval for the Oxford vaccine could be a positive factor for SII efforts to get approval in India.

“However, its important that just in the same way that the MHRA is going to make the decision based on adequate local data in the UK, that the CDSCO and its SEC also adequately look at the (ideally local) data on safety, efficacy to be able to make a decision.”

“And hence take such a decision such as approval only when they are adequately satisfied on this count.”

India & UK’s Covid numbers

According to the report, in the UK the move is being planned amid growing fears that England is about to enter a third lockdown.

The country Friday reported over 28,000 new cases of Covid infection and 489 deaths, according to official data.

In comparison, according to government data, India’s Covid pandemic growth has dropped to 2 per cent.

Also, the country’s Covid cases Friday dipped to below 23,000 and the number of deaths reported daily has remained below 400.


Also read: Govt expert panel asks Serum Institute to revise protocol for trial of Novavax Covid vaccine


 

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2 COMMENTS

  1. It is very clear that the regulators in India do not want to take an independent decision, whatever be the data. They can approve 1/2 dose followed by full dose, which is 90% effective. It is also reported that the vaccine is helpful in curbing the transmission. The sooner it is approve, the better; the medical workers, the essential services staff, the elderly at risk will be protected. Let this and other vaccines be made available commercially so that the so called non priority people can also have it and thus eliminate this virus.

  2. No indian official is going to approve any vacancies on fear of being later held responsible for any failure. They will just keep asking for time and wait for two three months till covid keeps spreading to See results in US, UK and Singapore

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