India appears to be only two days away from granting emergency use authorisation to a vaccine against the coronavirus disease, experts said on Wednesday after the UK’s regulatory authority approved the AstraZeneca-Oxford vaccine.
The Oxford version is expected to become the “vaccine for the world” as it is cheaper and easier to store than others.
India’s regulatory expert panel met on Wednesday afternoon and examined data on the AstraZeneca vaccine and a home-grown vaccine from the Hyderabad-based Bharat Biotech but called another meeting on January 1, the Union health ministry said.
The panel tasked to examine Covid-19 vaccine applications has sought additional information from both Bharat Biotech and the Pune-based Serum Institute of India, the company manufacturing the AstraZeneca vaccine in India.
Earlier on Wednesday, the UK government had announced that Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the AstraZeneca-Oxford vaccine for use across the UK after a “detailed scientific review” of the clinical trial data.
The agency has approved the vaccine for use on people 18 years or older in two doses, with the second dose administered four to 12 weeks after the first dose. The vaccine can be kept at temperatures of 2 degrees Celsius to 8 degrees Celsius, similar to standard refrigerators, for up to six months.
India’s expert panel under the Central Drugs Standard Control Organisation (CDSCO), the regulatory authority for drugs and vaccines, had weeks ago received three emergency use authorisation applications — from the US-based Pfizer, Serum and Bharat. Pfizer has sought more time to make presentations.
Medical experts tracking the vaccine development process said they expected the CDSCO panel to approve the AstraZeneca vaccine first because it had already demonstrated its protective efficacy while the Bharat Biotech vaccine was still undergoing efficacy trials.
Experts had predicted that the CDSCO panel would likely approve the AstraZeneca-Oxford vaccine for India only after the UK MHRA had approved it in its country of origin. “We now expect that emergency use authorisation for this product in India will come through at Friday’s meeting,” one expert said.
A senior vaccine science specialist said India was “entirely relying” on efficacy data for the AstraZeneca-Oxford vaccine from foreign trials. Serum’s clinical trial with the AstraZeneca vaccine has involved establishing only that it is safe and generates an immune response in the vaccinated volunteers.
Serum has indicated to the government that it has stockpiled and could supply 50 million doses of the vaccine in early January and deliver around 100 million doses per month from February or March.
An expert group on Covid-19 vaccination strategy had earlier this month recommended that four categories of people should receive the vaccines on priority — healthcare and frontline workers at high risk of occupational exposure to the coronavirus, people aged above 50 years, and those below 50 years with co-morbidities that put them at high risk of severe disease or deaths from Covid-19.
The group estimates that the four categories would make up 300 million people, for whom the government will require 600 million doses of vaccines.
The Centre is yet to outline the operational details of how the vaccine doses will be rolled out across the country.
