DCGI nod to Serum Institute of India to conduct phase 2 & 3 trials

▴ DCGI nod to Serum Institute of India to conduct phase 2 & 3 trials
Serum Institute allowed to carry on final trials of the Oxford University vaccine

Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) to conduct phase 2 and 3 human clinical trials of COVID-19 vaccine developed by Oxford University.

The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr VG Somani late last night after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.

The expert panel at the Central Drugs Standard Control Organisation (CDSCO) had on Friday recommended granting permission for phase 2 and 3 clinical trials of the vaccine - Covishield on healthy adults in India.

The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine are going on in the UK, phase 3 clinical trials in Brazil and phase 1 and 2 clinical trials in South Africa.

A record of 51,255 recoveries has been registered in the country in the last 24 hours. This is the highest number of recoveries in a single day since the outbreak of the pandemic in the country. With this, the recovery rate has improved to 65.43 per cent. The case fatality rate has further declined to 2.13 per cent.

The Health and Family Welfare Ministry said a total of 11,45,629 people have recovered from COVID-19 in the country so far. 54,735 new cases of Coronavirus have been reported in the last 24 hours, taking the total number of cases to 17,50,723. Presently, the total number of active Corona cases in the country is 5,67,730. In a single day, 853 deaths have also been reported taking the nationwide toll to 37,364.

The Indian Council of Medical Research said that a total of 4,63,172 tests were conducted by various laboratories within 24 hours. Overall, 1,98,21,831 tests have been conducted in the country so far. At present, 1,344 laboratories across India are conducting COVID-19 tests that include 913 government laboratories and 431 private laboratory chains.

Meanwhile, the World Health Organization has warned that the coronavirus pandemic is likely to be lengthy. The statement comes after an emergency committee of WHO met to evaluate the crisis six months after sounding the international alarm.

The committee also warned of the risk of response fatigue given the socio-economic pressures on countries. The panel gathered for the fourth time over the coronavirus crisis, half a year on from its January 30 declaration of a public health emergency of international concern - the WHO's highest level of alarm.

The committee highlighted the importance of sustained community, national, regional, and global response efforts.

The committee urged the WHO to provide nuanced and pragmatic guidance on COVID-19 reactions to reduce the risk of response fatigue in the context of socio-economic pressures.

Tags : #DCGI #WHO #DSMB #CDSCO #DCGI #SerumInstitute #OxfordUniversity #CoronaVaccineNews

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Achieving Healthier Lifestyles: Understanding India's New Dietary GuidelinesMay 11, 2024
The Link Between Childhood Sleep and Adult Psychosis: A Critical AnalysisMay 11, 2024
Uncovering Immunization Gaps: Insights into Measles Vaccination Challenges in IndiaMay 11, 2024
Unlocking New Horizons: Gene Therapies for Hearing Loss and BlindnessMay 10, 2024
Kerala Health Alert: West Nile Fever Cases Confirmed in Thrissur, Malappuram, and KozhikodeMay 10, 2024
Managing Health in the Heat: Demand for Medications Surges in IndiaMay 10, 2024
Sudhamukti Ayurvedic Medicine by OJSP: A New Era in Diabetes ManagementMay 10, 2024
The Role of Genetic Profiles in Alzheimer’s Therapy: APOE4 and Treatment ResponsesMay 08, 2024
Assessing Covishield Safety: Indian Research Offers Reassurance Amidst Rare Side Effect DiscussionsMay 08, 2024
Quadria Capital Invests $102 Million in NephroPlus to Boost Dialysis Services Across AsiaMay 08, 2024
Reducing Stigma, One Story at a Time: Media's Role in Mental HealthMay 07, 2024
When Your Body Makes Beer: Exploring the Curious Case of Auto-Brewery SyndromeMay 07, 2024
Hair Today, Gone Tomorrow: Why Guys Go Bald Before Marriage May 07, 2024
Menopausal Transitions and Mental Health: UCL Study Highlights Increased Depression RiskMay 07, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Harnessing AI for Early Alzheimer's Disease Diagnosis: IIT Indore's BreakthroughMay 06, 2024
Aurobindo Pharma's Bhiwadi Facility Under FDA Scrutiny: Understanding the ObservationsMay 06, 2024
Exploring the Role of Mediator Protein Complex in Cell Division: Implications for Disease ManagementMay 06, 2024
Akshay Tritiya Parna Mahotsav is to be held in the cityMay 04, 2024