World News – US – Covishield launch draws closer as UK MHRA approves AstraZeneca’s Covid-19 bump

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NEW DELHI: The UK Medicines and Health Products Regulator (MHRA) on Wednesday approved the emergency use of AstraZeneca’s Covid-19 vaccine to immunize people aged 18 and over. The approval recommends two full doses four to twelve weeks apart, according to the Anglo-Swedish company.

The approval for the recordings developed under the code name AZD1222 paves the way for an emergency license by the Drug Controller General of India V. . G. Somani for the « Covishield » branded version of the Serum Institute of India’s vaccine.

The Serum Institute had submitted its proposal for an emergency license for the vaccine earlier this month, but an independent panel of experts set up by the DCGI to review veterinary drugs had asked the company to return with updated data after the United Kingdom had given MHRA approval to AstraZeneca for the original version. The original version was jointly developed by AstraZeneca and the University of Oxford, with the former holding commercial rights.

AstraZeneca had signed a pact with the Serum Institute earlier this year under which the Indian company would commission the manufacture and supply of 1 billion doses of the vaccine to low- and middle-income countries, with a commitment to previously 400 Millions of shots ready by the end of 2020.

Together with the pact with other manufacturers worldwide, AstraZeneca discontinued a production capacity of up to 3 billion doses of the vaccine in 2021.

The AstraZeneca serum vaccine is so far the most important in the global fight against Covid-19, as it costs only 3 US dollars per dose compared to the two messenger RNA vaccines from the US companies Pfizer and Moderna calculate six times the amount. Unlike mRNA vaccines, which require subzero temperatures, the AstraZeneca serum vaccine can also be stored at 2 to 8 degrees Celsius.

« It’s proven to be effective, well-tolerated, easy to manage, and is being delivered by AstraZeneca at no profit, » said Pascal Soriot, CEO of AstraZeneca.

A comment from Adar Poonawalla, CEO of the Serum Institute, was not immediately available at the time of writing.

The efficacy results of the vaccine developed by AstraZeneca in collaboration with Oxford University sparked controversy after it was claimed that a dosage error had increased its effectiveness. Soriot admitted in an interview with the Sunday Times newspaper earlier this week: “We would have preferred a simpler set of results. « 

AstraZeneca’s clinical trials for its vaccine in the UK and Brazil included two separate dosing regimens. A lower dose gave a greater 90% effectiveness, while two full doses one month apart gave a 62% effectiveness.

The researchers couldn’t explain why the lower dosage regimen – half a dose followed by a full dose a month later – was more effective. Instead, the researchers said they accidentally came across it and called the superior results « coincidence ». .

Serum Institute, the contract manufacturer of the vaccine, conducted its own Phase 2 and 3 bridge study with two full doses in India, which showed an effectiveness of 62% in the AstraZeneca study. Bridging studies look at safety and immune responses to prove that the contract-made version is identical to the original version.

Poonawalla also said Monday that the vaccine is expected to receive an emergency license from the UK Medicines and Health Products Regulator and Indian Regulatory Agency in early January.

The company has made 40-50 million cans to date and would primarily sell these shots in India initially.

The company produces 50 to 60 million cans per month Covishield and will increase its capacity to 100 million cans by March when its third facility is operational. Poonawalla said he expected a vaccine shortage for the first six months, but after that, as more shots are fired, the supply-demand mismatch will narrow.

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Serum Institute of India, Vaccine, India, Adar Poonawalla, Pneumococcal Vaccine, AstraZeneca, Coronavirus

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