The World Health Organisation has cautioned Russia against rushing through with its novel Coronavirus vaccine. Russia has announced plans to approve a vaccine candidate being developed by Moscow’s Gamaleya Institute by the second week of this month. It has also said that the vaccine would be in market by next month, and mass vaccinations would begin by October.
The superfast speed of development and approval has led to scepticism.
“There are established practices and there are guidelines out… Any vaccine (or medicine) for this purpose should be, or course, going through all the various trials and tests before being licensed for roll-out,” Christian Lindmeier, a spokesperson for WHO, was quoted by the AFP news agency as saying in Geneva on Tuesday.
“Sometimes individual researchers claim they have found something, which is, of course, as such, great news. But between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference,” the spokesperson said.
Russia’s candidate vaccine was reported to have completed phase-I human trials in the second week of July. According to a news report in the Russia’s TASS news agency at that time, the phase-II trials were started on July 13. It is not clear whether the phase-II trials have also declared to have been completed. Usually, each of these phases can take several months to be completed. But considering the prevailing emergency situation, vaccine trials are being fast-tracked across the world.
However, Russia has indicated that it planned to approve the vaccine without undertaking phase-III human trials, the final stage in which a candidate vaccine is tested for its effectiveness in real-life situations, outside laboratory conditions.
This rush to produce the vaccine is leading to a lot of discomfort. Over the weekend, while testifying before a panel of US lawmakers, Anthony Fauci, a top US public health expert and one of the most trusted voices on the Coronavirus epidemic, had expressed doubts over the vaccines being produced in China and Russia. A Chinese vaccine has already been approved for limited use, without going through phase-III trials. It is being administered only to army personnel right now.
“I do hope that the Chinese and the Russians are actually testing the vaccines before they are administering the vaccine to anyone,” he had said.
Meanwhile, the Telegraph newspaper of London has reported that Britain was unlikely to use the Russian vaccine for its people.
The WHO spokesperson said the agency had not been informed by Russia about its plans to deploy the vaccine. “If there was anything official, then our colleagues in the European office would definitely look into this… In general terms, there are a set of guidances and regulations, rules, how to deal with safe development of a vaccine… These should be definitely followed in order to make sure that we know what the vaccine is working against, who it can help, and of course, also if it has any negative side effects,” the spokesperson said.
Developers of other leading vaccine candidates have said they hope to be ready with the vaccine by early next year, if not by the end of this year itself.
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Two Indian candidates complete phase-I trials
Meanwhile, the two Indian vaccine candidates that have started human trials are also progressing at great speeds. Dr Balram Bhargava, director general of Indian Council of Medical Research, announced on Tuesday that phase-I trials of these two candidates were all but over.
Bhargava said Hyderabad-based Bharat Biotech had completed its phase-I studies for its vaccine candidate at 11 of the 12 selected sites. The company had already started phase-II trials at these places. The other vaccine candidate, being developed by Ahmedabad-based Zydus Cadila, had also started phase-II trials at 11 sites, he said.
The two companies had begun injecting the participants for their vaccine candidates around July 15. Bharat Biotech was aiming to rope in around 1,125 participants in its phase I/II trials, while Zydus was targeting around 1,048 participants.
Both these companies had got approvals to carry out phase-I and phase-II trials at one go. In phase-I trial, the vaccine is tested for its safety in human beings, while in phase-II its ability to trigger immune response in human body is assessed. In normal times, each phase of trial takes up to several months to be completed.
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Entries on the Clinical Trials Registry of India for these candidates mention the estimated total duration of the trials for both these vaccines at 12-15 months. Zydus chairman Pankaj R Patel told The Indian Express that the first two phases of its trials would take around three months.
HUNT FOR CORONAVIRUS VACCINE: THE STORY SO FAR
- More than 160 vaccine candidates in pre-clinical or clinical trials
- 23 of them in clinical trials
- Six in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase-I human trials.
(Source: WHO Coronavirus vaccine landscape of July 31, 2020)
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