The interim findings of the AstraZeneca-Oxford Covid-19 vaccine trials showed 70% effectiveness in preventing people from getting infected. Serum Institute of India (SII) based in Pune is all geared up to seek emergency regulatory approval and hopes to get a go-ahead by the year end.

 

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

“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,” said SII CEO Adar Poonawala. He added that the company will have around 10 crore doses by January and so far has stockpiled around 4 crore doses. A majority of these will be marked as priority for India.

Adar Poonawala also said that Covishield will be available in the market at Rs 500-600 per dose, and at Rs 220-300 for the government. Two doses of the vaccine will be required. However vaccines from Pfizer and Moderna are expected to be priced higher. The Moderna vaccine may cost up to Rs 2,775 per dose, while Pfizer could price its offering around Rs 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.

The vaccine holds more promise for India because of its price, simpler supply chain and scalable platform, though the efficacy of the vaccine is much lower than the around 95% achieved by both Pfizer and Moderna. The vaccine can be stored in normal refrigerated temperature (2-8°C) and does not require the sub-zero cooling chain. Thus it is easier to transport, store and distribute even in remote areas, unlike the other two. Currently the Phase-III clinical trials of Covishield on 1,600 participants are ongoing across India and are expected to be completed by mid-December. 

“This vaccine’s efficacy and safety confirm that it will be highly effective against Covid-19. Also, the vaccine’s simple supply chain and our no profit pledge and commitment to broad, equitable and timely access mean it will be affordable and globally available, supplying hundreds of millions of doses on approval,” said AstraZeneca’s CEO Pascal Soriot.