India's COVID vaccine trials in key stages amid global studies' success

India detected 38,617 cases and 474 deaths on Wednesday (November 18), taking the country’s overall COVID caseload to 89.12 lakh. India’s 89,12,908 cases includes 4,46,805 active cases, 83,35,110 recoveries and 1,30,993 deaths. Globally, India is the second-worst hit by COVID-19.

The continuing spiral has intensified the country’s longing for a safe and effective vaccine, quickly distributed far and wide. However, it is easier said than done.

Vaccine candidates from Pfizer and Moderna are yet to be granted licences in India, and are likely to be first delivered to countries that have already signed deals with these firms. The doses are likely to arrive in India months later.

Also read:Life will be back to normal by next winter: Pfizer COVID vaccine developer

Five varieties in the making

On Monday (November 16), Dr VK Paul, member, NITI Aayog, who heads the high-level national expert group on vaccine administration, said the government was relying on five candidates being clinically tested in India. Paul said the candidates being tested locally will be able to fulfil the large domestic requirements.

The candidates include three that are in advanced stages of trials in India — the Oxford-AstraZeneca candidate for which Pune-based Serum Institute is conducting Phase-three clinical trials, Bharat Biotech’s Covaxin, which is also in Phase three, and Russia’s Sputnik V, which is expected to start phase 2-3 trials next week.

Also read:First batch of Russia’s Sputnik V COVID vaccine to arrive in India soon

The phase-three trials of India’s indigenous vaccine will have about 26,000 participants, Bharat Biotech said on Monday (November 16).

Trial volunteers will receive two intramuscular injections about 28 days apart. Volunteers who wish to participate in this trial should be more than 18 years old. Participants will be randomly assigned equally to receive either two 6 microgram injections of Covaxin or two shots of a placebo.

The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group, Bharat Biotech officials said.

The Hyderabad-based company has been developing Covaxin in collaboration with the Indian Council of Medical Research (ICMR) — India’s premier medical research body.

The first doses of the vaccine were administered to volunteers at the Nizam’s Institute of Medical Sciences in Hyderabad as part of the trial which will be monitored over the next year.

Covaxin has shown promising safety and immunogenicity data in trials done during phase one and phase two, the company said.

Covaxin in February?

On November 5, a senior Indian government scientist told a news agency the Covaxin vaccine could be launched as early as February — months earlier than expected.

“The vaccine has shown good efficacy,” senior ICMR scientist Rajni Kant, who is also a member of its COVID-19 task force, said at the research body’s New Delhi headquarters.

“It is expected that by the beginning of next year, February or March, something would be available.”

Covaxin has so far been evaluated in 1,000 participants in Phase 1 and 2 clinical trials, with the company saying that the results showed promising safety and immunogenicity data.

Of the 25 sites, eight have received approval from their respective ethics committees for the clinical trial, according to data on the government’s clinical trial registry. Each trial site has its own ethics committee, which monitors whether the trial conducted at the centre is meeting ethics and the study protocol according to clinical trial norms.

The primary endpoint of the late-stage trial, used to determine the efficacy of a vaccine, will be to see if the two-dose shot can prevent a patient from developing symptoms of the pandemic, according to the trial protocol. The secondary endpoint will be to measure how effective the vaccine is in avoiding severe symptoms of the disease and death in a patient.

Distribution worries

The cold-chain requirement for the anti-coronavirus vaccine candidate developed by Pfizer at a temperature of minus 70 degrees Celsius poses a big challenge, but the government is examining the possibilities if at all the vaccine has to be obtained by India, it said on Tuesday.

The government further said a national scheme on COVID-19 vaccine distribution is in its final stages of preparation.

NITI Aayog member (Health) Dr VK Paul said sufficient doses of the vaccine, as required for the Indian population, will not be available, but the government is looking at the possibilities and will work out a strategy for its procurement and distribution in case it gets the regulatory approvals.

Paul, however, said the arrival of the Pfizer vaccine in the country might take some months.

Last month, Nandan Nilekani, the former chairman of the Unique Identification Authority of India (UIDAI) and architect of Aadhaar, said the scale and distribution of the COVID-19 vaccine would be an enormous task for India. India does not have an adult vaccination system, unlike the US, where he says half the population of the US takes a flu vaccine every year.

In an interview, Nilekani said India would have to build the distribution of the vaccine from scratch. “My recommendation is that we build a completely new vaccination channel with 200,000 people who do vaccinations. Some of the current people can also participate but we will have to invest in creating a new infrastructure for vaccination at scale,” he said in an interview to The Indian Express.

Talking about the humongous scale, he said: “We have to vaccinate the entire population in two years, which means we have to reach 1.3 billion people in two years, and assuming that it is a dual dose vaccine, that’s 2.6 billion vaccinations, or 1.3 billion vaccinations a year. That’s more than a 100 million vaccinations a month and more than three million a day.”

He says India should design a system that can do 10 million vaccinations a day across the length and breadth of the country, but all unified by a common digital backbone, so that every person gets the same experience and the same information is recorded. “It is basically bringing population scale approach that we used in Aadhaar to a new issue (vaccination) which is, in fact, much more complicated.”

Also read:India’s cold chain a challenge as Pfizer makes COVID vaccine breakthrough