Why AstraZeneca-Oxford COVID vaccine is best suited for India over Pfizer, Moderna shots

British-Swedish drugmaker AstraZeneca and the University of Oxford on November 23 said their coronavirus vaccine was 70.4 percent effective in preventing COVID-19, as per the interim analysis of its late-stage clinical trials, conducted in the UK and Brazil.

The vaccine - called 'Covishield' - was found to be about 90 percent effective in a dosage regime that involved a half-dose first and then a full dose later. The positive data makes a strong case for AstraZeneca's India partner Serum Institute of India to seek Emergency Use Approval (EUA) from the Indian government, thereby raising hopes about the availability of the vaccine at the earliest.

What did the data say?

The interim analysis was based on 131 infections among participants who received the vaccine and those in a control group who were given an established meningitis vaccine. Of the 131 infected participants, 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.

The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of the vaccine - AZD1222 or a comparator, meningitis vaccine or saline.

The global trials are evaluating participants aged 18 years or over.

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

AstraZeneca's vaccine interim analysis data exceeds the 50 percent 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.

Dr Randeep Guleria, director of AIIMS and a member of the national task force on Covid-19 management, told CNN-News18 that Serum Institute should be applying for Emergency Use once AstraZeneca’s data of 70 percent efficacy is accepted by UK authorities.

Since the data was based on the phase-3 trial conducted in the UK and Brazil, which have diverse racial groups, and Serum Institute already completed the enrollment of phase-3 -- the data is expected to have enough rigour for the Indian drug regulator to grant a EUA.

In addition, AstraZeneca has conducted the largest ever clinical trial enrolling up to 60,000 participants globally, including South Africa, Kenya and Latin America, in addition to highly regulated countries such as the US and Japan.

Doesn't require ultra-cold storage conditions

While interim analyses of Pfizer and Moderna vaccines have shown that they are highly effective -  95 percent in fact - in preventing Covid-19 infections, they do have a problem. They are based on a novel yet complex mRNA technology and require a cold chain with ultra-low temperatures, which puts them at a disadvantage when compared to AstraZeneca's vaccine. AstraZeneca's 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. That should make the vaccine click in India.

Affordable price tag

The other big differentiator will be on the pricing front. The Serum Institute of India, which is developing, manufacturing and distributing AstraZeneca's Covid vaccine, would offer it at $3-$4 per dose for the government, while 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. Pfizer and Moderna vaccines will cost around $19.50 and $25-$37 per dose respectively. This doesn't include the cost of ultra cold chain requirements and administration costs.

Make in India

AstraZeneca's vaccine is developed in the UK, but will be made in India by the Serum Institute. It will not just be used for inoculating Indians, but will also be exported to other countries. The vaccine is aligned with the objective of the government's Atmanirbhar push. The vaccine is also production-ready. Serum is producing 40 million doses per month, and is in the process of scaling up capacity. Poonawalla said its 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.

AstraZeneca has made it clear that it provides access to the vaccine at no profit for the duration of the pandemic, and is committed to equitable distribution.