The story so far: India has begun vaccinating 12 to 14-year-olds as part of the vaccination drive that has so far administered around 180 crore doses and covered around 60% of the population.
What is India’s strategy for vaccinating adolescents?
India began vaccinating children aged 15 to 17 years on January 3 though the only vaccine permitted was Covaxin manufactured by Bharat Biotech. About nine crore vaccine doses have been administered to this age group so far. The government estimates that there are 7.4 crore eligible in this group, therefore it’s safe to assume that most have got at least one dose. The Drugs Controller General of India (DCGI) has recommended this vaccine based on safety and efficacy data submitted by Bharat Biotech from a trial involving 525 children across three age groups — 2 to 6 years, 6 to 12 years and 12 to 18 years. This week the Health Ministry announced that those from 12 to 14 years would now be eligible for vaccination. As of the latest available figures, 7.2 lakh in that age group have been vaccinated.
Corbevax is a protein-based vaccine manufactured by Biological E Ltd, that got emergency use authorisation from India's drug regulator on February 21, 2022, for the age group of 12 to 18 years. Government estimates suggest that 6 to 6.4 crore Indians are between 12 and 14 years old.
What is the scientific evidence on the safety and efficacy for Corbevax?
Corbevax was approved by the DCGI based on interim results of the ongoing phase II and III clinical trials. The vaccine had already been approved for adults last December. However, details of these efficacy studies have not been made public nor published in a peer-reviewed journal. The Centre had placed an order for 50 million doses of Corbevax at the cost of ₹145 per dose. However, there are two controversial aspects of the Corbevax trial.
One, the National Technical Advisory Group on Immunisation (NTAGI), which traditionally reviews available data on vaccine safety and recommends a vaccine to be publicly administered, has not scrutinised the Corbevax safety and efficacy profile for 12 to 14 year olds, according to NTAGI member, JayPrakash Mulayil. Secondly, its unclear why, when Covaxin and Corbevax are approved for 12 to 18-year-olds, only Corbevax is allowed to be administered.
It appears India has a policy of apportioning a fixed quota of vaccines by companies, a practice different from other countries where anyone eligible has a choice of vaccines.
How safe are the vaccines for adolescents?
This question has divided experts in India. One group argues that even though COVID-19 is less severe in children and younger adolescents than older adults, the incremental risk from adverse reactions to the vaccine may potentially outweigh benefits from the vaccine. Others, however, say that the data suggests the rare risk of long COVID in children which implies that it is unconscionable to not make an approved vaccine available to an eligible person. With the re-opening of schools, the substantially downward trend in cases and a relaxation of COVID-appropriate behaviour in general means that it is extremely likely that many more children are likely to be sick with COVID. This is despite serology surveys showing that 90% of children have already been exposed to the virus. The ongoing surge in cases in China, Hongkong and South Korea is already showing that the BA.2 variant is a sign that the pandemic is far from over and that India could soon see a reversal in case trends.
India has done a poor job of making public reports on adverse events following immunisation. Comparable reports from the US Centers for Disease Control say that for children aged 5 to 11 years who received Pfizer-BioNTech COVID-19 vaccine, approximately 97% were “non-serious.”
The most common adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) in the age group were related to “administration error” (because children were administered a smaller dose). However the CDC’s overall recommendation is that adolescents would be better off vaccinated than not.
Given that there are no m-RNA vaccines administered in India, and protein sub-unit vaccines are considered ‘safer’, it is likely that risks to children here won’t be any worse than already observed elsewhere.
THE GIST
Corbevax, a protein-based vaccine manufactured by Biological E Ltd, is the approved vaccine to be administered to those from 12 to 14 years.
The details of Corbevax’s efficacy studies have not been made public yet. Additionally, the NTAGI has also not scrutinised Corbevax’s safety and efficacy profile.
The ongoing surge in cases in China, South Korea etc shows us that the pandemic is far from over and that India could soon see a reversal in case trends.
- India has begun vaccinating 12 to 14-year-olds as part of its vaccination drive.
- Corbevax is a protein-based vaccine manufactured by Biological E Ltd, that got emergency use authorisation from the Drugs Controller General of India (DCGI) on February 21, 2022, for the age group of 12 to 18 years.
- The question of the safety of vaccines for adolescents has divided experts in India.
- Given that there are no m-RNA vaccines administered in India, and protein sub-unit vaccines are considered ‘safer’, it is likely that risks to children here won’t be any worse than already observed elsewhere.
