Coronavirus | Safety of COVID-19 vaccine paramount, says drugs regulator

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Safety and efficacy of the COVID-19 vaccine is paramount with the regulatory pathway for the vaccine in India seeing an accelerated rolling review and interim analysis of clinical trials, said Drugs Controller General of India V.G. Somani on Friday.

Dr. Somani was participating in a discussion on `Regulatory Pathways for COVID-19 vaccines, clinical trials, rolling reviews and adverse event monitoring’.


He added that India has a system in place for compensating participants for any adverse reaction to the new drugs being tested.

Secretary, Department of Biotechnology (DBT) Renu Swarup, who also participated in the discussion, added that the Department has set-up a vaccine expert committee which meets every two weeks and gives scientific inputs on meeting the regulatory requirements.

Speaking about the COVID vaccine development process, Senior Scientist, ICMR-National AIDS Research Institute (NARI) Sheela Godbole said that besides the accelerated dedicated research and rolling reviews, the vaccine development has also been provided an enabling environment, rapid recruitment facilities and on-going safety review.

"We also ensure safety by close regulatory oversight monitoring, having robust protocol, and trail design, trained competent investigators, independent assessment of all causality of adverse events and review of data from all trials for licensure,’’ she said.

540 deaths in 24 hours

Meanwhile India has reported 540 COVID fatalities in the past 24 hours with 77.78% of this from 10 States/UTs

"21.29% of new fatalities reported are from Maharashtra which reported 115 deaths, Delhi also saw a fatality count of 82 while West Bengal reported 49 new deaths,’’ said a release from the Health Ministry on Friday.

It added that continuing with the trend of the last seven days, India has reported more daily recoveries than the daily new cases during the past 24 hours. The trend has led to a continuous contraction of India’s active caseload which presently stands at 4,16,082 currently, noted the Ministry.


As per data released by the Ministry, 36,595 persons in India were found to be infected, 42,916 new recoveries were registered during the same period.

"The difference of 6,321 between new recoveries and new cases has led to a net decline of 6,861 cases from the total active caseload in the last 24 hours. India still continues to have one of the lowest cases per million population in the world (6,936) much lower than many other countries of the Western Hemisphere,’’ the Ministry said.

Also India’s recovery rate now stands at 94.2%, where 80.19% of the new recovered cases are contributed by ten States/UTs.

Maharashtra leads with 8,066 persons recovering from COVID while Kerala recorded 5,590 recoveries and Delhi registered another 4,834 daily recoveries.

"Ten States/UTs have contributed 75.76% of the new cases -- Kerala reported 5,376 cases in the last 24 hours, while Maharashtra registered 5,182 new cases while Delhi recorded 3,734 new cases,’’ the Ministry said.

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Printable version | Jan 21, 2021 5:01:25 PM |

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