Union Health Minister Harsh Vardhan on Thursday stated that a COVID-19 vaccine will be made available to the people of India by the beginning of 2021.

It is imperative to know that two indigenous vaccines developed by ydus Cadila and Bharat Biotech are currently undergoing clinical trials with both successfully completing phase 1 testing.

Meanwhile, the Drugs Controller General of India (DCGI) has allowed the Serum Institute of India (SII) to restart its phase two and three clinical trials for the Oxford-AstraZeneca COVID-19 vaccine.

This comes after the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial of the vaccine being developed by AstraZeneca and Oxford University.

DCGI VG Somani, in a letter to SII, has said that the institute’s reply has been ‘carefully examined’ as also the recommendations of the DSMB in India and in the UK.

“You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up,” the letter said.

The DCGI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events.

Meanwhile, Russia’s sovereign wealth fund on Wednesday agreed to supply 100 million doses of the world’s first COVID-19 vaccine Sputnik-V to Indian drug company Dr Reddy’s Laboratories as Moscow speeds up plans to distribute its vaccine-shot abroad.

Russian Direct Investment Fund (RDIF) reached agreements with Indian manufacturers to produce 100 million doses of the vaccine in India, which is a major consumer of Russian oil and arms.

RDIF said in a statement that Dr Reddy’s will carry out Phase III clinical trials of the vaccine in India, pending regulatory approval, with deliveries to India beginning in late 2020.

It is to be noted that the delivery of the vaccin would start only after the large-scale Phase III trials were complete, and the vaccine’s registration by regulatory authorities in India.

With a spike of 97,894 new cases and 1,132 deaths in the last 24 hours, India’s coronavirus tally has crossed the 51-lakh mark, according to the Union Ministry of Health and Family Welfare on Thursday.

The total case tally in the country stands at 51,18,254 including 10,09,976 active cases, 40,25,080 cured/discharged/migrated and 83,198 deaths, as per the Ministry of Health and Family Welfare.

Source link

By admin

Leave a Reply

Your email address will not be published.

Translate to