Expect more than one coronavirus vaccine in early 2021, says Harsh Vardhan

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India is expected to receive coronavirus vaccine from more than one source in early 2021, Union Health Minister Dr. Harsh Vardhan said on Tuesday. He said that the expert groups are formulating strategies to plan the distribution of coronavirus vaccine in the country.

“We are expecting that early next year we should have the vaccine in the country from maybe more than one source. Our expert groups are formulating strategies to plan on how to roll out the distribution of the vaccine in the country,” he said at Group of Ministers meeting.

The minister’s remarks come justa  day after the World Health Organisation (WHO) said it expects a vaccine to be ready for registration by the end of 2020 or early next year at the earliest

“As you know, we have about 40 vaccine candidates now in some stage of clinical trials, and 10 of them are in the phase three trials, which are the late-stage clinical trials, which will tell us about both the efficacy and the safety. So, the best we could make a guess or predict, looking at when a trial started and when it is likely to have enough data to submit to the regulators, is earliest from December of 2020 into the early part of 2021,” WHO chief scientist Soumya Swaminathan had told reporters.

Earlier on Sunday, Harsh Vardhan had warned citizens to stay away from large congregations and follow the guidelines issued by the government regarding precautions in view of the upcoming festive season. “The possibility of increased novel coronavirus transmission during winters as it is a respiratory virus and the transmission of respiratory viruses is known to increase during the colder weather,” he had said at a programme.

 

Back in September, Union Health Minister Dr. Harsh Vardhan had said that the first vaccine for COVID-19 is likely to be available in the first quarter of 2021. “Research to develop a vaccine is being done expeditiously. There are at least three viable vaccine candidates that are in the phase of clinical trials right now in the country. We are hopeful that within first quarter of 2021 it will be available,” Dr. Vardhan had said.

COVAXIN, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology, has completed its Phase I Human Clinical Trial. The phase II Human Clinical Trial is ongoing, according to the latest update available on the ICMR web portal. Another vaccine candidate, Covishield, jointly being worked on by the Serum Institute of India (SII) and ICMR, is also undergoing Phase II Human Clinical Trial. On October 8, the first batch of 100 participants, in the Indian trial of the vaccine developed by University of Oxford and AstraZeneca, were inoculated.

An official aware of the developments said that this part of the phase-2 trial will take 28 days following which the volunteers get the second dose mid-November. After initial data is received, the number of participants will be increased to 1,600. The first results will be out only in January, the official said. Zydus Cadila, the third vaccine candidate, has also completed Phase I Human Clinical Trial and is now conducting the second phase.

Principal investigators involved in the process said that the final phase of trials of the Oxford-AstraZeneca candidate and Bharat Biotech’s Covaxin will take some time.

One principal investigator said that he sees the possibility of completion of phase-3 trials only by February-March. “Large-scale population base trials are needed. We have to compare a group of people who are administered the vaccine with another set of people who are not given the vaccine to see rate of infection. Having antibodies is not an answer – it must be seen if the rate of infection is substantially low in those given the vaccine. I see the possibility of completion of phase-3 trials only by February-March.

“Large-scale population base trials are needed. We have to compare a group of people who are administered the vaccine with another set of people who are not given the vaccine to see rate of infection. Having antibodies is not an answer – it must be seen if the rate of infection is substantially low in those given the vaccine.

 

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