By Health In Five Writer
The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.
Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.
This assumes importance because of COVID-19 ‘Third-Wave’ is likely to affect children according to experts. India has been following the US in the pandemic, and the US has 37 lakh children with the Covid-19 infection. Considering India’s population, the number here could go into crores as per estimates. The Pune Platform for COVID-19 Response (PPCR) has urged all hospitals in the city to set up pediatric intensive care units in preparation of the third wave of the pandemic. While positivity rates and daily positive cases in Maharashtra are gradually reducing, the state is drawing up plans to prepare for the third wave, which health experts warn could hit children.
A possible third wave could hit the country in the August-September period, and there is no vaccination plan for those under the age of 18, nor are there any drugs or vaccine trials for children under way.
Lately, there has been a significant number of infections in children. Several children are being tested positive with different variants and double mutants. This has led to rising infections in the age group between 0 and16. As per an advisory issued by Motherhood Hospitals, parents were told to be extra cautious and not let their guard down. “Since the newborns to are vulnerable, breastfeeding is highly recommended as it builds baby’s immunity. It is also advisable for parents to strictly follow the vaccination schedule of their babies and not miss any doses, as this will shield the baby from infections and therefore a very crucial element in preventing the Covid infection,” said Dr Santosh Kumar, Consultant Neonatologist and Paediatrician at Motherhood Hospitals, as reported by The New Indian Express.