Govt Will Ensure Regulatory Facilitation for Serum Institute's Phase 3 Trial of Covid-19 Vaccine

Representative image.

Representative image.

The Serum Institute of India (SII) had on Monday said it will apply for licence from the Indian regulator to start clinical trials of the shot in a week's time.

India will ensure regulatory facilitation and actively consider supplementing resources for expediting the Serum Institute of India's phase 3 trial of a vaccine for COVID-19 developed by Oxford University.

With the trials of COVID-19 vaccine being developed by AstraZeneca and Oxford University showing encouraging results, the Serum Institute of India (SII) had on Monday said it will apply for license from the Indian regulator to start clinical trials of the shot in a week's time.

SII, the largest vaccine manufacturer in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it gets ready.

Asked if the Centre would be providing the same expedited process to SII as it provided to Bharat Biotech along with any funding support, NITI Aayog member VK Paul said, "Regulatory facilitation will be ensured. It is already being undertaken. If resources need to be supplemented, that will also be actively considered."

"The government of India will leave no stone unturned to ensure that people of India and the international community have access to an Indian vaccine as early as possible," he said.

Over multiple vaccines being developed across the world, Paul said two vaccines have showed immunogenecity and reactogenecity--the Wuhan and the Oxford vaccine -- and the initial results showed they are safe which is encouraging. He also said that two indigenous vaccines are in phase 1 and 2 of human trials.

The Drugs Controller General of India (DCGI) has permitted two vaccines -- one developed by the Bharat Biotech International Limited in collaboration with the ICMR and another one by Zydas Cadila Healthcare Ltd -- to go in for phase 1 and 2 human clinical trials.

"It looks promising, not just for India, but for the entire humanity. As we are moving towards the availability of a vaccine and the manufacturing will start, talks on how the government will procure and distribute them so that the needy gets it, have already been initiated," he said.

A coronavirus vaccine developed by the University of Oxford appears safe and induces a strong immune response within the body, scientists announced on Monday after the first phase of "promising" human trials against the deadly disease that has infected over 1.45 crore people and claimed more than six lakh lives across the world.

Doses of the vaccine were given to 1,077 healthy adults, aged between 18 and 55, in five UK hospitals in April and May as part of the phase one clinical trial, and results were published in the 'Lancet' medical journal.

The results showed they induced strong antibody and T-cell immune responses for up to 56 days after they were given. T-cells are crucial for maintaining protection against the virus for years.

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