As it has been proved time and again, the most effective and safe way to protect children from infectious diseases is by vaccination. COVID will be no exception. This article speaks about vaccine trials in children and possible implications for India, if steps towards vaccinating this vulnerable group are not undertaken.

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According to the first results on vaccination in children published in a peer-reviewed publication, Pfizer's COVID-19 vaccine was safe and efficacious in teenagers, with non-inferior immunogenicity compared to a sample of younger people. Alejandra Gurtman, MD, of Pfizer in Pearl River, New York, and colleagues reported that vaccine efficacy was 100 per cent at 7 days following the second dose in adolescents aged 12 to 15 without evidence of prior SARS-CoV-2 infection (95% confidence interval [CI]: 75.3 to 100%), with 16 cases in the placebo group and zero in the vaccine group.

Additionally, the safety profile was comparable to that of younger individuals, with participants experiencing temporary mild to moderate reactogenicity, including injection site discomfort, weariness, and headache, the scientists reported in the New England Journal of Medicine. The immunogenicity of the teenagers was not inferior to that of a group of people aged 16 to 25, according to the researchers.

The testing process

In March, the corporation released top-line figures in a press release but stated that the data will be submitted to a peer-reviewed publication. Earlier this month, the FDA increased the scope of Pfizer's COVID-19 vaccine's emergency use authorisation to include adolescents as young as 12 years old. A total of 2,264 adolescents aged 12 to 15 were included in the phase III study, all of whom were healthy or had a stable preexisting condition such as HIV or hepatitis B or C. They were given 30 mcg of vaccination or a saline placebo 21 days apart in a 1:1 ratio. Participants were advised to keep a symptom journal for 7 days after each dosage after immunisation.

There were 1,131 individuals who got vaccination and 1,129 who got placebo from October 15th, 2020 to January. 12th, 2021. Boys made up little over half of the participants, and 86 per cent of them were white. Some individuals (5%) had past SARS-CoV-2 infection and were thus omitted from the primary analysis (n=1,983). When these factors were taken into account, vaccination effectiveness remained at 100% (95% CI 78.1 - 100%), with 18 infections in the placebo group and zero in the vaccination group.

Within 11 days after the first dose, the vaccination group had three instances of COVID-19, compared to 12 in the placebo group, yielding vaccination effectiveness of 75%, albeit with broad confidence ranges (95% CI 7.6 - 95.5%).

Effects

The scientists contrasted a group of teenagers aged 12 to 15 with those aged 16 to 25 when it came to safety. The most prevalent systemic adverse effects were headache and tiredness, with a smaller proportion of teenagers reporting severe headache or severe exhaustion than the older group. After the second dosage, somewhat more teenagers than young adults (20% vs. 17%, respectively) reported a fever and the usage of antipyretics (37% vs 32%).

Adolescents experienced less serious adverse effects than young adults (0.6% vs. 1.7%, respectively), while a larger percentage reported lymphadenopathy (0.8% vs 0.2%). There were no thromboses, hypersensitive adverse events, or vaccine-related anaphylaxis, and none of the severe adverse events was considered vaccine-related. There were no fatalities.

The authors acknowledged that the teenage cohort lacked racial and ethnic variety, albeit they emphasised that all adolescents aged 12 to 15 were from the United States, whereas those aged 16 to 25 were recruited from all over the world. The researchers were unable to investigate the effects of other adolescent vaccinations on COVID-19 vaccination, nor could they determine if the vaccine protects this cohort against asymptomatic illness or viral transmission.

Implications for India 

As children make up such a large portion of the population, they are a natural target. According to the 2011 census, around 35% of the population is between the ages of 0 and 14, with another 10% between the ages of 15 and 19. Furthermore, children are recognised as extremely delicate disease vectors. They pose a significant concern to the most vulnerable since they are difficult to identify as sources of infection and isolation.

Until recently, it was widely assumed that COVID-19 had a lower impact on children than on other demographic groups. This is due to the fact that few children have died as a result of COVID-19-related problems or suffered severe symptoms if any at all. Recent developments, on the other hand, appear to tell a different narrative.

In comparison to the first wave, which caught us off guard and swamped the healthcare system, the second wave is remarkable for its enhanced virulence, which resulted in more illnesses in children and a greater fatality rate in the younger population. The incidence of illnesses reported among youngsters increased dramatically in March-April 2021. Furthermore, the number of children with COVID-19 who require hospitalisation and intensive care has increased dramatically.

This has pushed youngsters (or an extra 40% of the population) into the category of patients with COVID-19 infection who require extensive medical attention. This unquestionably opens the way for an emergency immunisation campaign for India's children and adolescents. A third wave is quite plausible, and it's possible that the third wave virus may mostly target children. Mostly because adults are either afflicted or immune to the disease. As a result, the COVID virus must find a new host, and children are the most vulnerable population in vast numbers.

The vaccination process

The Centers for Disease Control and Prevention has approved increasing the use of Pfizer-COVID-19 BioNTech's vaccine for children aged 12 to 15, making it a reality in the United States. This happened at a time when Indian specialists were already preparing for a third wave, with the worry that it would have the greatest impact on children, and with India's population of over 150 million children, the scale of preparedness will be enormous.

Pfizer completed phase 3 studies in 12-15-year-old adolescents and reported 100% effectiveness as well as a robust and well-tolerated antibody response. The experiment had 2,260 volunteers who were given two doses 21 days apart. Moderna is nearing the end of their phase 2 studies, which are investigating the safety, tolerability, response, and efficacy of two doses given to children 28 days apart. The phase 3 trials will involve 6,750 youngsters and will be conducted in both the United States and Canada.

Bharat Biotech has also begun testing, dividing children into three age groups: 12-18 years old, 6-12 years old, and 6 months to 6 years old. The organisation is now seeking individuals for clinical studies, which are expected to last at least 8 months. International firms undertaking studies have thus far documented the same adverse effects as adults.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.