It's Wednesday, 16 March, and India is gearing up to start vaccinating its 12 to 14 year olds against COVID-19—a natural next step after having covered lakhs of teens over 15.
For this age group of 12- 14, the vaccine of choice allowed by the Union Health Ministry is Biological E's recombinant protein sub-unit vaccine, Corbevax.
The announcement came just a couple of days ago, on 14 March, in a short press release by the Ministry of Health and Family Welfare. The statement comes with little information beyond the decision, which according to the Health Ministry was taken after 'due deliberations with scientific bodies'.
Questions like, why Corbevax? Why not other vaccines? What do the clinical trial results for Corbevax in this age group say?, remain unanswered.
FIT speaks to experts to find out what they think of the decision to vaccinate 12 to 14 year olds in India, and how much we know about Corbevax.
Right Time to Vaccinate Kids Under 15?
"I am happy with the decision of COVID-19 advisory committee and the government to vaccinate 12 to 14 years children," Dr Unmesh Upadhyay, the secretary of the Paediatric Association of Ahmedabad says, speaking to FIT.
Many health experts, including members of the paediatric association, have been lobbying for vaccinating kids below the age of 15 in the country. Echoing their stance, Dr Upadhyay says, "12 to 14 year children definitely need COVID-19 Vaccine because COVID in adolescent children behave like adult, so possibility of complications are there in this age group due to COVID."
In a previous article, FIT spoke to experts who talked about the risk of post COVID Multisystem inflammatory syndrome in children and how vaccines could help reduce this risk.
"COVID vaccines prevent school outbreaks as well as long COVID in children. COVID vaccination in children can also prevent indirect ill effect of COVID in children as far as their education,mental and emotional health are concerned."Dr Unmesh Upadhyay, Paediatrician, Secretary of Paediatric Association of Ahmedabad
Speaking to FIT, virologist Dr Shahid Jameel adds, "12-14 should be vaccinated. With infection at an all-time low since May 2020 and schools opening up, this is the right time to prepare for the future."
Some other experts, though, have their reservations.
Speaking to FIT for a previous article in February, virologist Dr Gagandeep Kang had said, "Children are at such low risk of severe disease, we should understand that the benefits of vaccinating children as a substantial proportion of the population are much lower than the benefits of vaccinating adults."
Other experts too have expressed their hesitancy when it comes to vaccinating children against sparse data of safety and efficacy.
"There is much less data for vaccines in children than there is for adults at the moment. Given that, caution is advisable, and a hasty rollout should not be done," says Dr Gautam Menon, Professor of Physics and Biology at Ashoka University, told FIT at the same time.
According to Dr Kang, instead of rushing into vaccinating masses of kids, we should be focusing large scale clinical trials in children to safely gauge what the best move would be as far as the COVID vaccine policy for kids in younger age groups goes.
However, she says, in such cases, the findings of clinical trials of the vaccines on children, as well as real world evidence of safety and efficacy in adults can be extrapolated to younger age groups safely.
"For other vaccine platforms we have data demonstrating immunogenicity in children, and for many vaccines, we have efficacy in adults," she says.
"There is no reason to think that vaccines which work in adults will not work in children, therefore, for licensed vaccines, we should expect that the vaccines will be safe and effective"Dr Gagandeep Kang, Virologist
But the thing about Corbevax is that we're not really sure how well it works against adults in the real world either.
Do We Know Enough About Corbevax?
Speaking of Corbevax, Dr Shahid Jameel points out that the recombinant protein subunit based vaccine "is time tested and very safe."
It must be noted, however, that the data from the clinical trials of the vaccine in children has not been made public yet for peer review.
"It would be best to publish clinical trials data. There should be no substitute for that," adds Dr Jameel.
This is especially critical given that there isn't any real world data of the vaccine's safety and efficacy in adults either.
Other experts have raised this concern too. Dr C S Pramesh, the Director of Tata Memorial Centre, Mumbai, for one, took to Twitter to urge the company to publish the clinical trial data.
"Huge respect for what you do, @PeterHotez, but would still like published efficacy (phase 3) data (not just immunogenicity, titres etc) before we champion #Corbevax?,"he wrote.
According to scientists at the Bayer College of Medicine in Texas, who helped develop the vaccine, and analysed the data from Corbevax's clinical trials in India that involved 3000 participants, "in a phase 3 trial conducted in India, CORBEVAX produced no serious adverse events, making it one of the safest COVID vaccines in use."
Writing for the journal, Scientific American, they also added that the trials in adults showed Corbovax provided a stronger neutralising antibody response against the Delta and Beta variants than Covishield.
The experts, however, did not comment on the findings of the clinical trial in children that is yet to be submitted for peer review.
The union health ministry has not provided an explanation for why it has decided to administer only Corbevax to children between 12 and 14 years.
"It appears to me that the Ministry’s plan is to use different vaccines for different age groups. Perhaps to simplify logistics. This is just my guess."Dr Shahid Jameel, Virologist
Another possible explanation for this could be that it's being done to streamline supply and not overburden the vaccine producers.
While the protein subunit vaccine technology is an old and dependable one that also simplifies the process of production and distribution, it is not clear yet how well it holds up against the Omicron variant.
It is not known yet if other vaccines will be allowed to this age group in the future to bridge this gap with future war
Serum Institute of India has urged the centre to include its recently DCGI approved COVID vaccine, Covovax to the national vaccination programme, for those over 12, reported PTI.
(Written with inputs from PTI and Scientific America.)
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