COVID19: DCGI gives nod to phase 2/3 trials of Biological E’s vaccine on kids aged between 5 and 18
The Drugs Controller General of India has given nod to Biological E Limited to conduct phase II and phase III clinical trials of its COVID19 vaccine on children between 5 and 18 years of age. The trials are expected to be conducted across 10 sites in India.
The trials are expected to be conducted across 10 sites in the country. Photo: Pixabay
The Drugs Controller General of India (DCGI) gave nod to Hyderabad-based Biological E Limited to conduct phase II and phase III clinical trials of its ‘Made in India’ COVID19 vaccine on children between 5 and 18 years of age with certain conditions.
The DCGI’s permission given yesterday on September 1 was based on the recommendations by the Subject Expert Committee (SEC) on COVID19. As per the media reports, the trials are expected to be conducted across 10 sites in the country.
Biological E’s Corbevax vaccine is a receptor-binding domain (RBD) protein subunit vaccine currently undergoing phase II and III clinical trials on adults. Reportedly this vaccine would be given in three doses.
In June this year, the Union Health Ministry had announced that Biological E will supply 300 million doses of Corbevax to the central government by December 2021.
It is to be noted that the drug regulators in India have recently approved Zydus Cadila’s ZyCoV-D vaccine for children above 12 years of age. However, the drive is yet to begin. Earlier, Union Health Minister Mansukh Mandaviya had hinted that children may start receiving their doses against the virus from September.
Also Read: COVID19 third wave in India expected to be less severe than the second wave: ICMR
It is feared that the possible ‘third wave’ will affect children the most. It is expected that the third wave may peak in October this year.
A recent report by a government body has pointed out that paediatric facilities such as doctors, ventilators, ambulances, are ‘nowhere close to what may be required’ in case a large number of kids get infected with the coronavirus. The report was prepared by the National Institute of Disaster Management (NIDM), a government agency for managing natural disasters in India. It recommended vaccination among young children and children with comorbidities should be an ‘immediate’ future priority.