Tuesday, November 24, 2020

Oxford vaccine ‘70% effective’, may get India nod by year-end

Oxford vaccine ‘70% effective’, may get India nod by year-end

Will be Sold At ₹220-₹300/Dose To Govt, ₹500-₹600 In Private Market

Rupali.Mukherjee@timesgroup.com

Mumbai:24.11.2020

Armed with interim findings of the AstraZeneca-Oxford Covid-19 vaccine trials — which showed 70% effectiveness in preventing people from getting infected — Pune-based Serum Institute of India (SII) is set to seek emergency regulatory approval and hopes to get a goahead by the year-end.

The ‘positive’ data raises hopes for a faster rollout of the vaccine in India, as the Astra-Zeneca data exceeds the 50% primary efficacy endpoint set by Indian drug regulator DCGI as part of its draft guidelines for Covid-19 vaccines.

“We will be applying for the emergency licensure very soon and hope to get it in a month or so. The final approval depends on DCGI’s decision,” SII CEO Adar Poonawalla told TOI. He added that the company has so far stockpiled around four crore doses, and will have around 10 crore doses by January. A majority of these will be marked as priority for India.

For ₹1.75L, Mum co will ‘fly you to US for vaccine’

As an anti-Covid vaccine inches closer to reality, a Mumbai-based travel firm put out a message on WhatsApp offering to fly clients to the US for a four-day stay and a shot for ₹1.75 lakh. Despite repeated attempts, TOI could not get in touch with the firm, but received a text saying, “We are developing vaccine tourism... We are not holding or procuring any vaccine. Everything we will arrange will be within laws of the US. We do not collect any advance or deposits now. We just need your registration with us with your name, email, cell, age, any one of physical complications and passport copy.” P10

Competing Covid vaccines are expected to be priced higher

Covishield will be available in the market at ₹500-600 per dose, and at ₹220-300 ($3-4) for the government, he added. Two doses of the vaccine will be required.

Competing vaccines from Pfizer and Moderna are expected to be priced higher. The Moderna vaccine may cost up to $37 or ₹2,775 per dose, while Pfizer could price its offering around $20 or ₹1,500.

“At this point, I am delighted that Covishield, a low-cost, logistically manageable and soon to be widely available, Covid-19 vaccine, will offer protection up to 90% in one type of dosage regime and 62% in the other dosage regime,” he said.

Globally, the clinical trials on ‘AZD1222’, which evaluated participants over 18 years, showed one dosing regimen with a vaccine efficacy of 90% when half a dose, followed by a full dose at least one month apart, was given. The other dosing regimen showed 62% efficacy when two full doses of the vaccine were given, with a gap of at least a month. The combined analysis from both dosing regimens resulted in an average efficacy of 70%. Though the efficacy of the vaccine is much lower than the around 95% achieved by both Pfizer and Moderna, the vaccine holds more promise for India because of its price, simpler supply chain and scalable platform. The vaccine can be stored in normal refrigerated temperature (2-8°C), and does not require the build-up of a sub-zero cooling chain, which makes it easier to transport, store and distribute even in remote areas.

The Phase-III clinical trials of Covishield on 1,600 participants are ongoing across India and are expected to be completed by mid-December. The interim data of trials— running since October— is promising, Poonawalla said.

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