The Indian Council of Medical Research (ICMR) is also involved in the phase 3 testing of the two vaccine candidates.(AFP)
The Indian Council of Medical Research (ICMR) is also involved in the phase 3 testing of the two vaccine candidates.(AFP)

Two out of five Covid-19 vaccines in Phase 3 trial stage: Govt

The two include the widely watched Oxford-AstraZeneca vaccine being tested by Serum Institute of India and the domestically developed candidate by Bharat Biotech.
By Rhythma Kaul | Hindustan Times, New Delhi
UPDATED ON NOV 18, 2020 06:32 AM IST

New Delhi are five vaccines against the coronavirus disease (Covid-19) at various stages of human trials in India, of which two candidates are in advanced phase 3 trials, the government announced on Tuesday.

The two include the widely watched Oxford-AstraZeneca vaccine being tested by Serum Institute of India and the domestically developed candidate by Bharat Biotech. In both trials, the Indian Council of Medical Research (ICMR) is also involved.

“As far as Covid-19 vaccine development is concerned, India is one of the countries at the forefront. Our Covid-19 vaccine trials are progressing well. Two of the five vaccines undergoing human clinical trials in India have reached the phase 3 stage,” said Niti Aayog’s VK Paul in the weekly Covid-19 media briefing on Tuesday.

For the Bharat Biotech-ICMR vaccine candidate, Paul added, phase 2 trials results are expected anytime now. A third candidate, Zydus Cadila’s ZyCovD, has also completed phase 2 trial and is awaiting results while a mandatory follow-up period nears its end.

Human trials of Russia’s Sputnik V vaccine, for which the developer Gamaleya Institute has collaborated with Hyderabad-based Dr Reddy’s Laboratories, is going to start next week, Paul said.

“The phase 2 going to phase 3 trial, which is going to be a combined trial, for which they have received the drugs regulators permission that is also prepared to start and is likely to begin by next week in India. Apart from that Biological E vaccine candidate will also have early phase1/2 trials; therefore a total of five vaccine candidates in India are currently being tested on humans against Covid-19, and are in various phases of trials,” said Paul.

The announcement comes a day after American biotech firm Moderna announced its vaccine had proven to be 94.5% effective in late-stage trials, the second vaccine candidate to report unexpectedly positive results after Pfizer-BioNTech did so on November 9.

“What we have is interim results for both the Moderna and Pfizer vaccines; these are not final results. And nowhere licensure has been granted to them,” said Paul, while adding that India is keeping a close watch on the progress of both of these.

Paul said that only one of these vaccines (Pfizer’s) would require cold chain maintained around -70 or -80 degrees Celsius,

“This is going to be a challenge and not easy for any country to establish this cold chain facility for such large volumes of vaccine. India is keeping a close watch in case this vaccine needed to be brought into the country. We are examining what can be done,” said Paul.

“We also are aware that doses for this vaccine, at least initially, will not be available in volumes that would take care of India’s Covid-19 vaccine demand, which is why vaccine development is being monitored quite carefully. Preparations are also being made to have everything in place in case we at all had to bring this kind of vaccine,” he added.

The government is banking on vaccine candidates that will be manufactured indigenously. “We are hopeful though that we will get success in at least one of the five vaccine candidates undergoing trials in India. We should get success, and these are also easy platforms to deliver with high availability of vaccine doses. Our indigenous manufacturers are capable of providing the vaccine numbers that we need for our population,” said Paul.

“We have high hopes from our own vaccines but if it was required to procure Moderna or Pfizer vaccine then we will draft strategy accordingly. We must also keep in mind that even if these two vaccines are available, these will first be made available at other places before being accessible to India. Having said that, we are in talks with the developers, and details will be shared as and when things finalise,” he added.

The National Expert Group on Vaccine Administration, chaired by Dr Paul and co-chaired by Union health secretary, Rajesh Bhushan, is in the process of drafting a time-bound scheme to ensure that people are vaccinated as soon as the vaccine is made available.

“A document has been drafted regarding this which is in its final stages of preparation, and has already been shared with the states governments, and their inputs taken. We are also in the process of finalizing the databases of various priority population groups which will be administered the vaccine if and when it becomes available. And there also we are in close collaboration with the state governments as well as with the other central ministries,” said Bhushan.

Experts said that which vaccine sees the light of day will depend on the phase 3 trial results.

“Phase 3 result is all about performance, and that is what we should be interested in looking at,” says Dr K Srinath Reddy, founder, Public Health Foundation of India.

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