Covaxin phase 2/3 studies have been completed for 2 to 17 years age group population and immunogenicity and safety data have been submitted to the Drugs Controller General of India (DCGI) for further approvals.Even as India’s cumulative Covid-19 vaccination coverage exceeds 75.89 Crore, Covid-19 vaccination of children with comorbidities in the 12 to 17 years age group is scheduled to begin no sooner that October, 2021 and that of children below 12 years of age to begin in the first quarter of next year, according to what government has announced.
As of today, around 60 percent of the eligible adult population of 94 crore has got first dose of vaccination and India is also in the process of vaccinating another 40 percent of adult population with first dose and second dose of over 80% of adult population will then follow.
India has 44 crore population below the age of 18 years of which 12 crore are in the 12 to 17 years age group.
The Government has also announced that India will begin vaccinating healthy children once the 94 crore adult population has been vaccinated.
The government also stated officially that India will produce 1.8 billion doses of Covid-19 vaccines by the year-end and its production will increase to 2.5 to 3 billion doses next year.
Experts have suggested that Indian companies should have a more proactive approach towards accelerating clinical trials for children vaccines and also ramping up production capacities. Countries like the US, Russia and Canada have prioritised vaccinating children. Chile and Malta are also among the countries who have already started vaccination in the age group of 12 years and above.
Currently, clinical trials are going on for other vaccines for children by Indian companies like Zydus Cadila and Bharat Biotech for 12 to 17 years and 2 to 17 years age groups respectively, of which ZyCovD of Zydus Cadila has been already licensed and will start roll out of children vaccines by next month.
Clinical trials are ongoing for Covovax, a Covid-19 vaccine developed by American company Novavax Inc. for children below 18 years of age by the Serum Institute of India (SII). Clinical trials are also ongoing for Biological E protein subunit vaccine Corbevax, on children aged 5 to 18 years and above and it is expected to be rolled out by December this year, according to official sources.
“Covaxin phase 2/3 studies have been completed for 2 to 17 years age group population and immunogenicity and safety data have been submitted to the Drugs Controller General of India (DCGI) for further approvals. The vaccine is likely to hit market by October 2021,” informed Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech International Limited (BBIL).
Zydus Cadila’s Zycov-D- the world’s first Plasmid DNA Vaccine for Covid-19 is the only vaccine today approved by the DCGI for emergency use in children aged 12 years and above besides the eligible adult population of 94 crore.
While speaking to Financial Express Online recently, Deepak Sapra, CEO, API and Services at Dr Reddy’s Laboratories informed, “Clinical trial on Sputnik vaccine for children in the age group of 12 to 18 is currently going in Russia with reference to a dose ranging study which is currently evaluating what kind of dose can be administered to this age group towards achieving the desired immunity. Safety data has been encouraging which will be followed by immuno-genecity data. The same kind of trial for children vaccines will also be conducted in India,”
Talking about the efficacy of Sputnik vaccine for Covid-19 for immunization in adult population, he emphasized, “We have had studies comparing Sputnik vaccine against other vaccines such as Pfizer and Moderna as far as the effect on other variants like Delta variant is concerned. One of the peer reviewed journal published by our Russian partner demonstrates an efficacy of about 83 per cent for Sputnik against delta variants versus about 76 percent for Moderna and 42 per cent for Pfizer.”
According to Dr Ishwar Gilada, Consultant in HIV and infectious diseases and Secretary General, Organised Medicine Academic Guild (OMAG), “Even if 100% of adult population is fully vaccinated, we will need 25% per cent of the below 18 population to be vaccinated, to be able to achieve the required target of 70% of total population to attain ‘herd immunity’, if at all the concept of herd immunity holds true for the coronavirus.”
On reopening of schools, Dr Gilada commented, “Based on the responses from parents on reopening of schools with 97% in favour of opening up schools, schools should be opened with staggered hours into evening and morning shifts with six hours in each shift. One third of the children who aren’t infected, can be tested on Covid-19 Antibody test. Those negative for IgG antibodies can attend online and the two third who have developed natural immunity can attend schools based on staggered hours. However vaccination drives which are barely 5 to 6 hours daily should also be extended and also kept open on Sundays and public holidays to enhance vaccination coverage.”
Experts also project that with the current pace of 1 crore vaccination daily, vaccination coverage can be improved further more so as the Union Government has pre-purchased 30 crore vaccines from Biological-E. With the ramping up capacities India is poised to witness significant volumes in vaccine production.
“If we consider and extrapolate the results of fourth sero-survey that showed 65% sero positivity among the 44 crore below 18 population, then we will be in safe zone even if we do not vaccinate this population as 65% of them presumably have got natural immunity by getting infected,” according to clinicians.
According to a Mumbai based practicing physician Dr Sujay Shivaji Patil, “Vaccines are a safe and effective mode of providing active immunity to all individuals including the pediatric population against infectious diseases. Before a vaccine is approved by any regulatory authority, it is thoroughly evaluated by a long-standing, rigorous and transparent process. Considering the current situation, vaccination globally has managed to put brakes on Covid-19 spread and subsequent mortality. But still, the picture is not clear whether vaccination is efficacious against the new variants.”
Giving his views on vaccinating children, Ahmedabad based pharmaceutical consultant Dr Sanjay Agrawal said, “The unvaccinated children and adults who stayed mostly indoors since March 2020 might not have been exposed to the virus much and so may not have developed adequate antibodies to thwart the viral infection. Diverse opinions are being given about the possible impact of the third wave on children. However, the Indian Council of Medical Research (ICMR) data of a national sero-survey shows that 65% of them may have antibodies. In addition, children may be less vulnerable as they have less ACE-2 receptors in the lungs.”
Is vaccination safe for children and adolescents?
Globally, very few vaccines are being tested in individuals above 12 years of age, including mRNA vaccine made by Moderna and Pfizer–BioNTech and two Chinese vaccines made by Sinovac and Sinopharm. The United States, China and Israel have already taken this initiative of administering vaccines in this particular age group. Overall, vaccines look safe in adolescents and as safety evidence accumulates in this age group, strategy would be to test vaccines in the lower age groups.
According to Dr Sushmita Bhatnagar, Pediatric Surgeon and President, Association of Medical Consultants (AMC), Mumbai, “Covid vaccinations are important for the entire population, which include children as children can be asymptomatic carriers and can be the cause of serious covid infection to the vulnerable group. Once adults are vaccinated, covid vaccination in children should begin in a phased manner beginning with children with comorbidities first.”
Recommendations
American Academy of Pediatrics (AAP) recommended COVID-19 vaccination for all children and adolescents 12 years of age and older who do not have contraindications using a COVID-19 vaccine authorized for their age use. Apart from Covid-19 vaccination, routine childhood and adolescent immunization is also necessary. Vaccination indirectly could liberate children to return to school or work, celebrate holidays and travel.
Vaccinating children would benefit both directly – protecting children against severe pediatric cases of Covid-19 and post-infectious conditions such as multisystem inflammatory syndrome in children [MIS-C] and indirectly protecting others by reducing the spread of the virus.
Apart from vaccination, children should continue with physical distancing, wearing masks and washing their hands.
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