Oxford University and British Swedish drugmaker AstraZeneca on November 23, claimed that their coronavirus vaccine candidate ‘Covishield’ showed 70.4 per cent response against the Covid-19 virus, in the interim analysis of its late-stage clinical trials, conducted in the UK and Brazil.

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The vaccine was found 90 per cent effective, in the dosage that involved first a half dose and later a full dose. Pune based Serum Institute of India (SII), which is the partner with AstraZeneca for the production of the vaccine, with the upcoming positive data makes the case strong for seeking, Emergency Use Approval (EUA) from the Indian government, thus raising hopes for the availability of the vaccine very soon in the country.

What did the interim analysis data say?

The interim analysis, that depended on 131 infections among participants who got the antibody and those in the control group who were given an established meningitis vaccine.30 cases of COVID-19 were people who received two doses of the COVID vaccine, while the rest, or 101 of those, got the control jab, of the 131 infected participants.

Why does the interim data raise hopes of COVID-19 vaccine availability in India soon?

AstraZeneca’s vaccine candidate’s interim analysis data shows the efficacy of 70 per cent which is much more than the set 50 per cent primary efficacy endpoint set by Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO), as part of its draft regulatory guidelines for Covid-19 vaccines.

AstraZeneca will now have to approach the Medicines and Healthcare products Regulatory Agency (MHRA), the UK drug regulator, for Emergency Use Approval (EUA). This is expected as soon as possible.

Director of All India Institute of Medical Sciences, Dr Randeep Guleria informed the media that Adar Poonawalla led SII after AstraZeneca’s data of 70 percent efficacy is accepted by UK authorities will be applying to the Indian government for the Emergency use of the vaccine.

In the phase-3 clinical human trials that were conducted in the UK and Brazil comprised of diverse racial groups, and the SII has already completed the enrollment of phase-3 -- the data is expected to have enough rigor for the Indian drug regulator to grant a EUA.

It is also worth mentioning, that AstraZeneca enrolled as many as 60,000 participants globally, the largest ever clinical human trial, included participants from South Africa, Kenya, Latin America, and regulated countries such as the US and Japan.

No need for ultra-cold storage facilities

While the vaccine candidates of Moderna and Pfizer have shown a response of 95 per cent against the Covid-19 virus. These vaccines are based on m-RNA technology which requires a cold chain as they need to be kept at ultra-low temperatures.

On the other hand, AstraZeneca’s ‘Covishield’ does not require such a cold-chain facility as the vaccine can be stored, transported, and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

Affordable price

While the vaccines of Moderna and Pfizer are expected to be priced between $ 19.50 and $25-$37 respectively, AstraZeneca has planned to offer the vaccine at $3-$4 to the government and for private players, the cost of two doses would work out to around Rs 500 - Rs 600.

Serum Institute's CEO Adar Poonawalla said the vaccine will be priced at a maximum of Rs 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals.

Make in India

While the ‘Covishield’ vaccine which is being developed by Oxford University and AstraZeneca in the UK, will be mass-produced in India by SII. The vaccine is not just being manufactured for the Indians but will be exported to other countries too. The SII has signed an agreement of 50-50 sharing of the vaccine, in which 50 per cent of the vaccine produced will be used in India, while the other half will be exported to other countries. Giving a push to PM Modi’s Atmanirbhar Bharat, the vaccine is in the stage of mass production. SII is currently, producing 40 million doses every month, and the process of scaling up the manufacturing capacity.

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According to Poonawalla CEO of SII, the COVID-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the use of the general public.