- Pfizer conducted phase 3 vaccine trials on children, found 100% efficacy
- Bharat Biotech is recruiting children to begin COVID vaccine trials
- The third wave of COVID-19 will impact children the most: Experts
New Delhi: COVID vaccine for children is now a reality in the USA, where the Centers for Disease Control and Prevention has recommended expanding usage of Pfizer-BioNTech’s COVID-19 vaccine for children between 12-15 years of age. President Joe Biden has called the move “one more giant step in our fight against the pandemic.” This comes at a time when Indian experts are already prepping up for a third wave and the fear is it may impact children the most and given India has over 150 million children, the scale of preparation needs to large.
We are likely to have a third wave and there is a possibility that a third wave virus will predominantly target children. Mainly because adults are either infected already and or immunised. So, the COVID virus has to find a new host and the most vulnerable group in large numbers are the children.
India’s priority needs to include vaccinating children against COVID as well and here’s where the vaccines for children stand now.
Expected COVID-19 Vaccine Contenders For Children
Companies like Pfizer, Moderna, Johnson and Johnson, and even Bharat Biotech are working on trials.
Pfizer has conducted phase 3 trials in adolescents between 12-15 years of age, they found 100 percent efficacy and robust and well-tolerated antibody response. The trial was conducted on 2,260 volunteers, administering 2 shots 21 days apart.
Moderna is very close to finishing their phase 2 trials at this point, evaluating the safety, tolerability, reaction, and effectiveness of the 2 doses on children, 28 days apart. They plan to conduct the phase 3 trials on 6,750 children and will be conducting the trials in both US and Canada.
Bharat Biotech has also started trials and has divided children into categories – between the age group of 12-18 years, 6-12 years, and 6 months to 6 years. The company is recruiting participants for trials as of now and the trials may take at least 8 months.
So far the international companies conducting trials have reported the same side effects as for adults.
Experts Speak On The Need To Vaccinate Children in India
Talking about the preparations for children’s vaccine at Bharat Biotech, Dr Sanjeev Sinha, Professor for Medicine at AIIMS, tells NDTV,
DCGI has given permission to conduct trials for children in the age group of 2 years to 18 years, and they have divided 3 groups like 12-18 yrs, 6-12 yrs, and 6 months to 6 years. So, they are now starting trials between 12-18 yrs of age and this is a very important trial and they are going to start this trial in three siTes, one is AIIMS New Delhi, AIIMS Patna, and AIIMS Nagpur. Then, they will do phase 2 and phase 3 trials to see the safety, immunogenicity, side effects, and efficacy.
He also informed that in this trial, Bharat Biotech is planning to enroll a healthy population, and the injection dose has to be decided.
Explaining the 100 percent efficacy in children that was found in the Pfizer vaccine, Dr. PS Narang, Pediatric, Max Healthcare, tells NDTV,
Kids have a very good immune system and when we do an efficacy study, 2,260 children were enrolled, and out of them half got the vaccination and half got placebo. And then among the placebo, you check how many got infected. before you enroll you check that these are new patients, meaning that they haven’t had subclinical or asymptomatic infection. So if they get the vaccine, whatever antibodies will develop will be because of the vaccine. For efficacy, you have got two groups, one which is vaccinated and the other which is not vaccinated. So after those not vaccinated, out of the 1089 subjects, they had 16 cases of COVID and the group which got vaccinated, haven’t got any COVID infection till now. That brings efficacy. Now this efficacy, once done on a bigger level, will depend on what kind of efficacy the vaccine has on a larger group. Considering the present scenario, since the group which is vaccinated haven’t had any infection after the vaccination, looks like a promising result.
Referring to the size of the sample for the Pfizer vaccine, Dr Vikram Talaulikar, Senior Clinical Lecturer, University College of London says that it is a good number, given the situation that the second and the third wave might hit children more.
Relatively, you will see more children being affected because the adults have been immunised, I think sometimes you have to rely on the preliminary studies such as short studies of 2000 or 3000 individuals. Of course, in science it’s always good to get bigger numbers, when you have 10,000 or 20,000 people, it gives you more confidence in the results. But we don’t have time and given the scenario, we have seen in the last few months across different countries in the world, I think these are still robust data especially if you’ve got 2,500 children, you’ve nearly got 100 per cent efficacy and that might become slightly low when you start immunising in communities. It still is a fantastic figure and with almost no major side effects being reported.
Dr Narang says that it is very important for India to have trials on children in the country itself.
We know that the viral variant is changing so it is important to conduct the trials in the same geography. If Pfizer has to roll out in India, they may get an emergency license but still, some trials in the post-licensing will be done which will be helpful in knowing the effectiveness here. As far as the variants are concerned, they are coming from the same virus, some of the variants like the ones seen in Brazil, South African, there has been some immunity with the vaccine against them as well. But in the future, when the variants change, these vaccines and their technology will have to be upgraded and updated.
While there is a clear need for a vaccine, India also faces a high degree of vaccine hesitancy, especially in rural India. While Urban Indians are trying their best to secure a slot for getting the jab, people in rural India still have questions. Aman Gupta, Healthcare Communication specialist and CO-founder SPAG said,
Vaccine hesitancy in India is an old problem, there are many other vaccines for which people are not convinced to get. In the current situation, science will do its part but how will you communicate this science to the masses, how you show the relevance. The government has to play its role, with campaigns at the state and central level, to not only to get it done but also to champion the cause.
He says that the polio vaccine campaign is by far the biggest public health success, where in the last couple of years, polio vaccines are free.
It took concentrated effort where the government played its role, but other stakeholders like rotary clubs, people in the community, media person each of them played their role to get an effective campaign and I think that’s what is really required here, Mr. Gupta signed out.
NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.