New Delhi: The Drugs Controller General of India has granted restricted emergency use authorisation (EUA) to Biological E’s COVID-19 vaccine Corbevax for the 12 to 18 years age group, subject to certain conditions, official sources said on Monday.However, the government has not taken a decision yet on vaccinating those aged below 15 years.The health ministry recently had said additional need for vaccination and inclusion of population for vaccination is examined constantly.The DCGI’s approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological E’s application.The Drugs Controller General of India (DCGI) had approved Corbevax, which is India’s first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in emergency situations in adults on December 28.It has not been included in the country’s vaccination drive.
The DCGI on Monday granted restricted EUA to Corbevax for the 12 to less than 18 years age group subject to certain conditions,” an official source said.
In an application sent to the DCGI on February 9, Srinivas Kosaraju, the head of quality and regulatory affairs at Biological E Limited, had said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study, which indicated that the vaccine is safe and immunogenic.
The proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase 2/3 clinical study) considering the current pandemic and widespread of COVID-19 vaccine in India, Kosaraju had said in the application.
The Corbevax vaccine is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at two to eight degrees Celsius temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.According to the health ministry, the company has conducted phase 1/2 and 2/3 clinical trials of its COVID-19 vaccine in the country.Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
NDTV – Dettol have been working towards a clean and healthy India since 2014 via the Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ population, indigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity, which is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and the country can become a Swasth or healthy India.