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Covaxin safe for kids, generates higher antibody response in them than adults, says Lancet paper

The results of the phase ⅔ clinical trials of the indigenous Covid vaccine have been peer-reviewed and published in the The Lancet Infectious Diseases journal.

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New Delhi: Results of Covaxin trials performed on children and adolescents aged 2-18 years, published in The Lancet Infectious Diseases medical journal Thursday, have shown that the vaccine was “well tolerated and induced higher neutralising antibody responses than those observed in adults”. 

These results are combined findings of phase 2 and 3 of the clinical trials.

So far, around 10.7 crore doses of Covaxin have been administered among Indian children aged 15-17 years, according to data available on the Cowin dashboard. This age group was cleared for Covaxin administration on 3 January.

Bharat Biotech — which developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune — conducted the phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years age group. 

The clinical trial, conducted last year, has shown safety, less reactogenicity, and robust immunogenicity, according to the findings. The data was submitted in October 2021 to the Central Drugs Standard Control Organisation (CDSCO), after which the vaccine was approved by the Drugs Controller General of India (DCGI) for emergency use in the 6-18 years age group. 

Also Read: AstraZeneca vaccine safe, effective in kids, finds Lancet study. WHO still says for adults only

‘No serious adverse events’

Between 27 May, 2021, and July 10, 2021, 526 children were enrolled in the trial and divided into three groups — group 1 (>12 to ≤ 18 years), group 2 ( >6 to 12 years) and group 3 (≥2 to 6 years). 

“Vaccination was well tolerated, with no differences in reactogenicity between the three age groups, and no serious adverse events, deaths, or withdrawals due to an adverse event,” read the findings of the trial.

“Local reactions mainly consisted of mild injection site pain in 46 (26 per cent) of 176 participants in group 1, 61 (35 per cent) of 175 in group 2, and 39 (22 per cent) of 175 in group 3 after dose 1,” they further said.

After dose 2, mild injection site pain was again recorded in 39 (22 per cent) of 176 in group 1, 43 of 175 (25 per cent) in group 2, and 14 of 175 (8 per cent) in group 3, the report noted, adding that after dose 2, there were no cases of severe pain and few reports of other local reactions. 

After dose 1, the most frequent “solicited systemic adverse event” was mild to moderate fever, reported in eight (5 per cent) of 176 participants in group 1, 17 (10 per cent) of 175 in group 2, and 22 (13 per cent) of 175 in group 3. No case of severe fever was reported, and rates of all fever were all 4 per cent or less after dose 2, the findings stated. 

Dr. Krishna Ella, chairman and managing director, Bharat Biotech, said in a statement: “…Covaxin has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children, for primary immunization and booster doses, making Covaxin a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically.”

‘Efficacy studied in adults’

The study looked at the immune response generated in children and not the actual efficacy of the vaccine in preventing serious disease and death, as the latter had already been proven in adults. 

“We previously demonstrated that two doses of BBV152 (Covaxin) are effective in preventing Covid-19 due to SARS-CoV-2 infection in adults, and now show that the vaccine is equally well tolerated and immunogenic in seronegative children aged 2–18 years,” the authors wrote. 

“No adverse events of special interest have been reported to date; however, a supplementary surveillance study is ongoing, which will provide more information on rarer adverse events,” they added.

Covaxin is a ready to use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy.

Globally, inactivated vaccines and mRNA vaccines form the majority of Covid-19 vaccines approved for administration to children younger than 18 years. 

Accounting for the value that the study added to existing knowledge, they wrote that the vaccine “induced immune responses in children that were equivalent or superior to those previously demonstrated in adults in whom the vaccine has demonstrated protective efficacy”. 

“This finding suggests that BBV152 might be equally efficacious in protecting children against severe Covid-19. Because BBV152 is an inactivated vaccine, it is unlikely to lead to adverse events that have implied to be associated with paediatric vaccination with mRNA vaccines such as cases of Guillain-Barré syndrome, thromboembolic events, or myocarditis or pericarditis,” wrote the authors.

(Edited by Gitanjali Das)

Also Read: Health ministry claims Covaxin has WHO approval for use in under-18s, but it doesn’t


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