Friday 30 October 2020

COVID vaccine: 50 crore doses for 25 crore people by July 2021

Two vaccine candidates, the indigenously developed by Bharat Biotech in collaboration with ICMR and the one developed by Zydus Cadila Ltd, are in Phase II of human clinical trials

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Union Health Minister Dr Harsh Vardhan today said the Narendra Modi government was working tirelessly to ensure there was a fair and equitable distribution of vaccines to prevent and resist the coronavirus disease (COVID) when they would be ready. “Our govt is working round the clock to ensure that there is a fair and equitable distribution of vaccines, once they are ready. Our utmost priority is how to ensure vaccine for each and everybody in the country,” said Harsh Vardhan while interacting with social media users during Sunday Samvaad 4.

“There is a high-level expert body going into all aspects of vaccines. Our rough estimate and the target would be to receive and utilise 400 to 500 million (50 crore) doses covering approximately 25 crore people by July 2021,” the minister said.

As for the priorities in the distribution of vaccines, Dr Harsh Vardhan said that the Ministry of Health was preparing a format in which states would submit lists of priority population groups to receive the vaccine, especially health workers engaged in the management of COVID-19.

The list of frontline health workers will include both government as well as private-sector doctors, nurses, paramedics, sanitary staff, ASHA workers, surveillance officers and many other occupational categories who are involved in tracing, testing and treatment of patients. The deadline for completion of this is the end of this October. The centre is closely guiding the states, asking them to submit details about cold chain facilities and other related infrastructure, required down to the block level.

The minister said that there was a high-level committee under the chairmanship of Niti Aayog Member (Health) VK Paul that was drawing up the entire process. The government is procuring vaccines centrally and tracking each consignment real-time until delivery to ensure it reaches those who need it most.

The minister said that these committees were working on understanding the timelines of availability of various vaccines in the country, obtaining commitments from vaccine manufacturers so that the maximum number of doses for India inventory and supply chain management are available while prioritising high-risk groups. This is work in progress, to be completed by the time the vaccines are ready to ensure the swift roll-out of the immunisation program, the minister said.

Will there be a level-playing field for various clinical trials? Dr Harsh Vardhan said there were set principles that designed all proposed clinical trials in India. The Subject Expert Committee set up by the Drug Controller General of India stringently reviews the trials, he said.

Recently, the DCGI formulated draft guidelines on regulatory requirements for licensure of coronavirus vaccines in India. On a question about Phase III Clinical Trial of Russia’s “Sputnik-V” vaccine in India, Dr Harsh Vardhan clarified that the matter was still under consideration. No decision has been taken as yet on the Phase III trials, the minister said.

Dr Harsh Vardhan said, stating that adverse events developing after vaccination are common, the adverse events after vaccination included local reactions such as pain at the injection site, mild fever and redness, anxiety-related such as palpitations, syncope or fainting and that these events are transient, self-limiting and do not affect the protective response of the vaccine.

The minister detailed the ethical concerns of human challenge experiments, “India is not planning to venture into such trials until the method is proven to have an established benefit as per global experience. India has robust processes in place to ensure the vaccines that successfully complete the clinical trials are safe and effective against the novel coronavirus,” he said.

“When conducted, human challenge studies should be undertaken with abundant forethought, caution, and oversight. The value of the information to be gained should clearly justify the risks to human subjects,” the minister said.

Anti-COVID vaccine: Progress in R&D

Currently, two vaccine candidates, the indigenously developed by Bharat Biotech in collaboration with ICMR and the one developed by Zydus Cadila Ltd, are in phase 2 of human clinical trials.

The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in India.

There is growing hope that a vaccine against coronavirus may be given the green light by health regulators by the end of this year to be rolled out for a vaccination programme in six months’ time or even less, according to a UK media report.

The vaccine candidate under trial by University of Oxford scientists in collaboration with pharmaceutical giant AstraZeneca is the furthest in the process of trials and, according to a report in ‘The Times’, it could be given the required clearances by Christmas in December.

The Hyderabad-based Dr Reddy’s Laboratories has applied to the Drugs Controller General of India for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against COVID-19 in India, sources said.

The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as its distribution.

Upon regulatory approval in India, RDIF will supply to drugmaker Dr Reddy’s 100 million doses of the vaccine, the firm said last month.

India’s COVID-19 caseload went past 65 lakh, while the number of people who have recuperated from the disease crossed 55 lakh, according to the Union Health Ministry data updated on Sunday.

The recovery rate stands at 84.13%.

The total coronavirus cases mounted to 65,49,373 with 75,829 people testing positive for the infection in a day, while the death toll climbed to 1,01,782 with the virus claiming 940 lives in a span of 24 hours, the data updated at 8 AM showed.

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