India could get Covid-19 vaccine by December

In what may cheer up millions around the world, pharmaceutical major AstraZeneca on Monday announced that its Covid-19 vaccine developed in partnership with Oxford University has been proven "highly effective" in protecting people from the novel coronavirus infection.

The company will now seek an emergency use listing from the World Health Organization and approach regulatory authorities around the world for a conditional early approval of the two-dose vaccine for front line workers and vulnerable groups identified by the governments.

With 70% efficacy and its ability to be transported and handled at normal refrigerated conditions (2-8 degrees Celsius), this could very well be India’s first Covid-19 vaccine if the Indian drug regulator is convinced with the trial data.

AstraZeneca's Indian partner, Pune-based Serum Institute is independently conducting safety and immunogenicity clinical trials on 1,600 patients across India.

SII chief executive officer Adar Poonawalla on Monday said that the company was aiming for an approval by the year-end and the vaccine might be available in a limited way either by December end or in early January. By July 2021, up to 400 million doses of the vaccine could be made available.

Poonawalla said the vaccine would have a maximum retail price of Rs 1,000 for the private market but pointed out that his company was negotiating with the Union Health Ministry for a purchase price for the government.

Based on the trials carried out on 23,000 individuals in the UK and Brazil, AstraZeneca said that the vaccine offers 70% efficacy. Surprisingly, one of the regimens in which only a half-dose is used in the first shot offers 90% protection whereas the second regimen with two full doses generates 62% efficacy. The two doses are being given at least one month apart.

“These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply," Andrew Pollard, chief investigator of the Oxford vaccine trial at Oxford University said in a statement.

The regimen with one half and a full dose that generates 90% efficacy was given to 2,741 individuals whereas the second regimen with two full doses were administered to 8,895 people. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%.

An independent data safety monitoring board determined that the analysis met its primary endpoint showing protection from Covid-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed as the vaccine was well tolerated across both dosing regimens.

"A vaccine with 70% efficacy is very good because the idea was that a vaccine even with 50% efficacy is good enough in a pandemic situation. The added advantage of the AstraZeneca vaccine is that it can be transported to every corner of the country as it doesn’t need an ultra low cooling environment for storage,” Chandrakant Lahariya, an independent public policy and health systems expert told DH.

Two other Covid-19 vaccines developed by Pfizer-BioNet and Moderna showed an efficacy in excess of 90%. But the first one needs a storage temperature of minus 80 degrees Celsius while the Moderna vaccine is more expensive than the AstraZeneca one.

More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.