Clinical trials are now underway to test the safety and efficacy of covid-19 vaccines for children, the Union health ministry has indicated. This comes against the backdrop of schools reopening in several parts of India and of children being potential carriers of the highly infectious disease.
The available vaccines have not been evaluated in children so far, a health ministry document said, to clear the air on why covid-19 vaccination is not being provided to children. The government, however, said that clinical trials are now underway to test the efficacy and safety of the vaccines in children.
Covid-19 affects all age groups, but morbidity and mortality are much more in adults, particularly those above 50 years, the government said. Children are either asymptomatic or have mild infection, it said. The general practice is to first evaluate a new vaccine in the older population and then assess the safety and efficacy in the paediatric population, the government said.
In a separate significant development, Bharat Biotech on Wednesday announced the first interim analysis of its BBV152 (Covaxin) vaccine. The whole-virion inactivated covid-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trials.
The development may help Bharat Biotech secure an approval on its plea to conduct Phase 3 trials of Covaxin on children aged 5-18 years. The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) had earlier asked Bharat Biotech to produce efficacy data on adults for its vaccine before seeking permission to test it on children.
“Trials are being done. The need is for senior citizens and those with comorbidities and also healthcare and frontline workers who are more susceptible to be vaccinated," said Dr Renu Swarup, secretary, department of biotechnology, ministry of science and technology.
Efforts are on to develop comprehensive vaccines for all age groups, including children, to prevent them from contracting covid.
“Pfizer, Janssen, and Moderna are doing studies in children 12 and older in the US and will go lower. Astra Zeneca is evaluating the vaccine in children 6-17 years in the UK. Novavax is planning its studies in younger children. Covaxin has to submit the interim efficacy data of adults to get permission for the study in children, but they had a few children over 12 years in their phase 2 study," said Dr Gagandeep Kang, the vice chair, Coalition for Epidemic Preparedness Innovations (CEPI), a global non-profit aiding a vaccine development platform for covid, and professor, Christian Medical College, Vellore, Tamil Nadu.
India under ‘Unlock 4’ allowed partial opening of schools for students of Classes IX-XII from 21 September. Many schools, including government institutions, now plan to start physical classes. However, the nationwide covid-19 vaccination drive only covers the healthcare and frontline workers, besides senior citizens and those above 45 years with comorbidities.
“Covid vaccination is focused on the most vulnerable population in the country, which are elderly and those with comorbidities. As they are most vulnerable, they should be protected first. However, we will gradually cover all age groups with covid-19 vaccines, including children as and when the science progresses in this direction," said Balram Bhargava, director general, Indian Council of Medical Research, and secretary, department of health research, ministry of health and family welfare.
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