With Bharat Biotech’s inactivated virus-based Covid-19 vaccine Covaxin now set for phase 2 and 3 clinical trials on children in the 2-12 years age group, the stage is set for a pediatric range to hit the market. Experts believe this is a critical step to ensure a break in transmission.
Apart from Covaxin, two more vaccine candidates would be available for pediatric use in India. Zydus Cadila’s ZyCoV-D has been tested on children above 12 years and on Monday the USFDA authorized the use of Pfizer’s mRNA vaccine on kids as young as 12 years.
Bharat Biotech has already conducted trials on children 12 years and above. Bharat Biotech Chairman and Managing Director Krishna Ella had said last year, “Our vaccine is safe, and built on time-tested and proven technology. It can be given to a six-month-old or a 60-year-old.”
Outlook got in touch with Dr. Prabhat Maheshwari, Chief- Neonatal & Paediatric Critical Care, Artemis Hospitals Gurgaon to answer all your questions:
What is Covaxin?
Covaxin is India’s first indigenous Covid-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR. It is an ‘inactivated vaccine, which means it is made up of killed coronaviruses, making it safe to be injected into the body. Since it is a killed virus thus has no chances to infect or replicate. It helps improve a person’s immune response to the coronavirus.
How phase 2/3 trials for Covaxin in the 2-18 age group will be conducted?
Drugs Controller General of India (DCGI) gave the nod for Covaxin trials on children from 2-18 age groups. The trial involves two vaccine doses injected on day 0 and day 28. It will be carried out on 525 healthy volunteers at various sites including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur.
Do kids need vaccines as much as adults?
Children seem to have a lower likelihood of catching the severe disease or developing serious complications than adults and deaths seem rarer in the case of kids. As per the reports of the Indian Council of Medical Research (ICMR), 97 lakhs of people in India have been infected with the novel coronavirus, and nearly 12 percent of the infected population falls under the age of 20 years. Rest 88% are above the age of 20 and beyond, as per reports. Children who develop multisystem inflammatory syndrome (MIS-C) need to be handled with extreme care and attention. Vaccines might block transmission of SARS-CoV-2, so vaccinating children could be beneficial. Although, the already predicated third wave of Covid-19 is inevitable and might infect the children, therefore, we need to be prepared to fight such a situation. Under such evolving situation, we need to vaccinate our people as soon as we can including kids.
Covaxin has been approved for trials on children between 2-18. Tell us something about that.
India’s drug regulator has permitted to conduct clinical trials of Covaxin on children between 2-18 age groups paving the way for the first coronavirus inoculation to be tested on minors in the country. The move comes as experts in India have underlined the need to vaccinate people below the age of 18 since there cannot be a proper opening up until the entire population is protected.
What can be the side effects of vaccination on kids?
Generally, vaccination is safe in children. Common side effects that are usually seen are fever, pain, and swelling at the injection site, headache, and body ache. Rarely can it cause allergic reactions in susceptible individuals? We shall have more knowledge once the phase 3 trial results are out.
Are there any precautions that kids need to follow? Please explain.
No specific precautions but vaccination should be avoided in case of any active infection. In case of any doubt, a pediatricians’ advice should be taken.
Will there a specific diet for them before and after vaccination? What would it be?
No specific diet is recommended.
Anything else that needs to be kept in mind before and after vaccination?
Make sure that the child is not suffering from any active infection at the time of vaccination. The post-vaccination child should be observed for 30 minutes for an immediate reaction. If any fever or pain after vaccination then it should be treated with oral paracetamol.
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