Dr Dharmakanta Kumbhakar
(The writer can be reached at drkdharmakanta1@gmail.com)
India is fighting a battle today against the second Covid-19 wave. The numbers of positive cases and related deaths are increasing every day. The more dangerous and extremely contagious UK variant, South African variant, Brazilian variant, California variant, double-mutant strain and triple-mutant strain of SARS-CoV-2 have been detected in the second Covid-19 wave in India in addition to the earlier known SARS-CoV-2 variants. More vulnerability of getting infected by these new SARS-CoV-2 variants, getting severely affected, requiring more ICU treatment and more deaths among the younger people are seen in the second wave as compared to the first one. Moreover, several children below the age of 18 years and even newborns have been tested positive for Covid-19 in this second wave. To bring the second wave outbreak in India under control, the Central Government has emphasized the need to increase focus on effective testing, tracing, treatment and vaccination.
As a result of extraordinary global collaboration and determination, Covid-19 vaccines arrived within less than a year after the discovery of the virus. Researches show that these vaccines are remarkably effective and safe. India started a massive vaccination drive (Covaxin and Covishield) for health workers, frontline and essential workers, and people above the age of 50 years with comorbidities in January 2021. Later it was extended to persons above the age of 45 years too. As of today, India is inoculating three Covid-19 vaccines (Covaxin, Covishield and Sputnik V) to all individuals above the age of 18 years with a hope to end the acute phase of the second wave.
There are 472 million children in India under the age of 18 years, representing 39% of the country's total population. It is a major concern now, how to keep our children safe from Covid-19. For children, there is a relatively low risk of the disease. Most Covid-19 infections in children are mild and they recover fully. Serious illness is rare but well-described; this includes the inflammatory and potentially deadly condition called Multisystem Inflammatory Syndrome in Children (MIS-C). The Covid-19 related mortality rate in children is too low in comparison to adults. Yet, the children must be protected from Covid-19. For this, we must vaccinate our children against Covid-19. India will never be Covid-19-free if we don't vaccinate the children as they are a link in the transmission process. Experts believe vaccination of children is a critical step to ensure the break in transmission in India. Getting India back to a place of safety and normalcy, every citizen of India including the children must be vaccinated.
The overall effects of Covid-19 on children have been calamitous in India. Apart from getting infected by the virus, their education is suffering from 2020 a lost year for a generation of children, while 2021 is also going to be a lost year. Keeping the schools open for in-person classes is critical for children's education and development, having unvaccinated and susceptible children, despite their lower risk of infection and transmission, can become significant if cases in India continue to rise. Paediatric Emergency Department visits for mental health issues have been on the rise. These problems stem from societal pandemic responses and are not direct effects of the virus on children. To overcome all these problems related to children, we must focus on vaccination of children against Covid-19 as a safety measure.
A major concern now is when India will get a Covid-19 vaccine for children. At present, no Covid-19 vaccine has been approved by the Drug Controller General of India for children below 18 years of age. While the case for Covid-19 vaccines for children is clear, accumulating robust evidence of vaccine safety and efficacy for children is a priority. The children are not little adults; we can't just assume a vaccine will have the same effect on a child as it does for someone older. Children have striking differences in their metabolic and immunological processes compared to adults. Younger children have more active immune responses that translate into stronger reactions, such as higher fever and localised reactions. An uncommon immunological phenomenon is an antibody-dependant enhancement, where antibodies to SARS-CoV-2 elicited from a vaccine may result in worse disease. We learned from prior vaccine trials in children for respiratory syncytial virus and dengue infection that vaccines may paradoxically intensify disease, resulting in greater risk to the vaccinated children. Because of this, long-term safety data in children must be meticulously studied before recommendations can be made for Covid-19 vaccine deployment in children.
Before recommending Covid-19 vaccines for children below 18 years of age, clinical trials need to be completed. Running paediatric vaccine clinical trials is more complicated than adult clinical trials due to ethical issues and a host of factors unique to children. Realizing the importance of a Covid-19 vaccine for children, many vaccine products authorised for emergency use in adults (Pfizer, Moderna, Johnson & Johnson) initiated clinical trials in children 12 years and older. The American Academy of Paediatrics (AAP) has recommended the Pfizer vaccine for all children of 12 years of age and older on May 10, 2021, who don't have contraindications using a Covid-19 vaccine authorized for use for their age. Earlier, all people in America 16 years and older were eligible to receive the Pfizer vaccine. Pfizer is currently conducting clinical trials on children as young as six months old; it will likely seek an emergency use authorization for its vaccine for children ages 2 to 11 years in September 2021.
The good news for the children in India is that Bharat Biotech's Covaxin has already conducted clinical trials on children of 12 years and above. Covaxin is now set for phase 2 and 3 clinical trials on children in the 2-12 years age group. Covaxin is an inactivated virus-based vaccine. It is the same technology as the injectable polio vaccine and hepatitis A vaccine. These vaccines are given to infants and have proven to trigger an immunogenic response in children. Covaxin should also work on children above 2 years. However, this needs to be backed up by data and hence more clinical trials are necessary. Apart from Covaxin, Ahmadabad-based Zydus Cadila's needle-free ZyCoV-D has been tested on children above 12 years. As per Sharvil Patel, managing director of Cadila Healthcare, they have sufficient data on the safety and efficacy of this vaccine on children and they will seek approval from the regulator soon.
Moreover, Pfizer is now in discussion with the Indian Government about bringing its vaccine to India. As India has adopted a liberal policy to allow foreign vaccines that are approved by regulators like the USFDA, UK-MHRA to come to India without conducting bridging clinical trials, companies can simultaneously conduct bridging studies when the vaccine is available in India and then submit the data. This will pave the way for the Pfizer vaccine to be used on children in India too.
Experts say that there will be a third Covid-19 wave in India and the children and newborns are at risk in the possible third wave as they are yet to be inoculated against the infection. We appeal to the Central Government to identify a vaccine that can be administered to children at the earliest. Till then; physical distancing, wearing age-appropriate masks, regular hand hygiene and respiratory hygiene is the best course for improving outcomes for children in the short term.