India will have approved COVID 19 vaccine in early 2021

Vaccine Progress:

India is on course to have an “approved” vaccine within the first quarter of calendar year 2021 and Pune- based Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, is well placed to deliver the first vaccine, according to a report out on Thursday from Bernstein Research, a top Wall Street research and brokerage firm.

“Globally, there are four candidates that are close to an approval by the end of the CY2020 or early 2021. Through partnerships India has access to two of those – AZ/Oxford’s viral vector vaccine and Novavax’s protein sub-unit vaccine with AZ/Oxford’s vaccine ahead by a quarter,” says the Bernstein report, which IANS has reviewed.

“With their existing capabilities and capacities SII is best positioned to commercialise one or both of the partnered vaccine candidates depending on approval timing, capacities and pricing.”

Also Read: UK soon to give emergency approval to any COVID-19 vaccine breakthrough

Details:

Data from Phase 1 and Phase trials look promising for both these candidates “in terms of safety and the vaccines ability to elicit an immune response”. The way things look now, the report indicates that both vaccine candidates “will require two doses to be administered 21/28 days apart”.

The report strikes an upbeat tone on India’s “global capacity equation” and does not foresee “manufacturing scale up challenges”.
Serum Institute of India, the report says, could supply 600 million doses in 2021 and 1 billion doses in 2022, out of which 400 to 500 million “should be available in India in 2021” in the context of the company’s commitments to Gavi The Vaccine Alliance and lower and middle income markets.
The report estimates that vaccine volumes will be split 55:45 between the government and private market.

Who will have access to vaccine ?

“We believe the government channel will have first access to the capacities but also believe there will be a sizable private market. In terms of funding, manpower and delivery infrastructure the Government will struggle to shoulder the burden on its own and we expect the private market to step in and supplement.”

Also Read: How effective is CORONIL by Patanjali for COVID-19

Costing:

SII has announced that Gavi will procure vaccines at $3 per dose. The Bernstein report uses that as a benchmark to estimate procurement price to be around $3 a dose for the government and end consumer price of about $6 per dose. Apart from SII, the report lists at least three other Indian pharma companies – Zydus, Bharat Biotech and Biological E – which are working on their own vaccine candidates and are currently in Phase 1 and 2.

Between SII, Bharat Biotech, Biological E, and some smaller players, India produces around 2.3 billion doses of various vaccines every year.
SII alone is the globally largest manufacturer of vaccines with 1.5 billion doses capacity. Every two out of three children globally gets a shot manufactured by SII. In early August, SII entered into a partnership with Gavi, The Vaccine Alliance and the Bill and Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries (LMICs).

Atmanirbhar bharat role in vaccine:

If you read the news carefully, they are talking about mass production and supply in 2022. Indians be prepared for being Atma-Nirbhar until then

The collaboration pumps upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and lower and middle income nations as quickly as the first half of 2021.

The overall vaccine market in India is estimated at “$6 billion spread over FY 21-22”, according to Bernstein.

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UK soon to give emergency approval to any COVID-19 vaccine breakthrough

Legal change will enable population to be immunised as quickly as possible

The government has said that any new and effective COVID vaccine will be given emergency approval for use in the UK and an expanded workforce will be trained to enable more and more people.

A change in the law would allow the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), before being granted temporary approval for the vaccine, as it has been licensed by European authorities, which is a normal procedure.

Also Read: Coronavirus Vaccine Updates:  Oxford’s Covishield Set to provide Vaccine by End of Year in India, Others by Early Next Year

Ministers say this will happen only if the vaccine meets the highest safety and effectiveness standards.

England’s Deputy Chief Medical Officer, Prof Jonathan Van-Tam said: “We are making progress in developing the COVID-19 vaccine, which we hope will save lives, protect health workers and return to normalcy in the future Will be important in.

If we develop effective vaccines, it is important that we make them available to patients as soon as possible but only once safety standards are met. Today’s proposals suggest improved access.

Suggest ways to create and ensure that COVID-19 and many people are protected from the flu and to ensure that any vaccine used is both safe and effective, without sacrificing completely.

In MHRA Unlicensed medicine or vaccine has the power to grant temporary authorization, where a product proves to be safe and effective and is in the patient’s best interest based on available evidence.

A consultation is being started on Friday, which will last for three weeks And health experts and key stakeholder groups Will amend the Human Medicines Regulations 2012 to seek opinion and advice on the proposals.

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