Results of Covid-19 vaccines’ trial to take a few weeks, says VK Paul
India will have to wait a few weeks for the initial results of Phase I/II human trials being conducted on two indigenous vaccine candidates against the coronavirus disease (Covid-19), as the stage is set for more advanced trials on a third option, VK Paul, who chairs one of the national task forces on Covid-19 management,said on Tuesday.
The two candidates that are in phase I/II human trials are drug maker Zydus Cadila’s ZyCov-D and Bharat Biotech’s Covaxin. Bharat Biotech received the central drugs controller’s approval to conduct human trials on June 29, and Zydus Cadila on July 2.
“It will take a few weeks for the results of the 2 indigenous anti-Covid-19 vaccines that are currently in phase I/II human trials in India,” Paul, who is member (health) at Niti Aayog, the government’s policy think tank, said at a Covid-19 related health briefing on Tuesday.
“The antibody titer needs to be evaluated, and other reactions that are seen in this phase, which we will get to know in a couple of weeks. After that regulatory pathways will be decided and accordingly clearances sought from the regulatory body,” Paul said.
Antibody titer is a test that measures the amount of antibodies within a person’s blood to assess the strength of the body’s immune response to a disease.
The government is closely tracking the progress of the candidates being tested by Bharat Biotech and Zydus Cadila amid a global race against time to find a vaccine for the coronavirus disease, which has claimed in excess if 778,000 lives worldwide since it broke out in the central Chinese city of Wuhan late last year.
Paul also said Serum Institute of India will begin the phase 3 human trials in a day or two in India on the Covid-19 vaccine candidate developed by UK’s Oxford-AstraZeneca. Pune-based Serum Institute has struck a production and clinical trials deal with AstraZeneca for the AZD1222 vaccine, which has until now been tested in the most number of people -- 1,077 -- among the close to 200 vaccine options being tested across the world.
“Results for the one in Phase 3 trial will take longer as Phase 3 trial usually takes longer. It’s not appropriate to comment on a specific time line but it will be a few weeks longer than the phase I/II trials. Phase I/II could take 3-4 or even six weeks to show results. So just hold on, it will take time… it is about waiting and watching as it is a scientific process that takes its own time. Only after one stage is reached and crossed that we can talk about the next stage. As of today as things stand, we are on right track and let’s wait for those milestones to be met,” Paul added.
Paul said that once the indigenous vaccines or for that matter any other vaccine reaches the stage of availability, the government will be ready with a procurement and distribution plan.
“The plan will be based on how to make the vaccine accessible in terms of supply chain based on the vaccine’s characteristic -- whether it would require a single dose or multiple doses or would need cold chain to be maintained for storage among other things,” he said.
The national expert group on Covid-19 vaccine met prominent domestic vaccine producers on Monday to help chalk out a plan. As reported by HT on Tuesday, the expert group asked the manufacturers to come up with a roadmap in the next three days on production capacity, pricing, and the kind of support they expect from the government.
“We have requested them to provide more clear-cut data; information on their individual capacities and how these capacities will pan out with time. How they can ramp up these capacities from where they are today to where they could be. This is a dialogue in motion, and we will have updates from them in this process of dialogue. We can assure you India has huge capacity; in fact, we were pleasantly surprised to find out how much capacity we have within the country,” Paul said.
Pricing of the vaccine will be a key factor. “We did request them to indicate what possible prices could be. Pricing perhaps being very complex because some of these vaccines are at an early stage; some insights into where the price range would be, but this information will be refined as we would move along. There is no firm information that we can share today but yes we are asking what kind of a price range we are looking at for the vaccine from individual vaccine manufacturers.”
“A word of caution: please don’t assume any vaccines that is going for trial will be successful. We want it to succeed; we want these three and many others to succeed but it keep in mind that it is not always 100% success as we develop any vaccines. Keep your fingers crossed,” he said.
Experts also say that a vaccine will be instrumental in preventing the spread of infection in the long run.
“A vaccine will be needed to check the disease spread but we don’t know when an effective vaccine be available for use even though all our efforts are being directed towards making it happen as soon as possible. A good vaccine is the most cost-effective way of preventing a disease,” said Dr Amita Jain, head, microbiology department, KGMU (King George’s Medical University), Lucknow (Uttar Pradesh).
Total Covid-19 deaths: 778,506
Participants for Oxford vaccine Phase I/II trials: 1077