Bharat Biotech's Covaxin is 'well tolerated' and effective in children between the ages of 2 and 18 finds a study published in the medical journal Lancet Infectious Diseases.
The findings of the peer reviewed study also suggest that the home-grown COVID vaccine induced higher neutralising antibody responses in this age group than in adults.
How much do we know about Covaxin for younger children? What did the Lancet study find?
We break it down.
Key Points of the Study
The study involved 6 hospitals across India.
It was conducted between May 27, 2021, to July 10, 2021
526 kids between the ages of 2 and 18 were enrolled.
They were put into three groups of 12 to 18 years, (176), 6 to 12 years (175), and 2 to 6 years (175).
The participants were given two 0.5 ml doses of Covaxin COVID vaccine with a gap of 28 days.
Immunocompromised children, and those who had already been infected with COVID previously were excluded.
The researchers checked for adverse events 7 days post-vaccination and the level of neutralising antibody titres were checked 28 days after the second dose.
These results were also compared to the serum samples of adults who received the same vaccine in the same schedule.
What the Study Found
The vaccine was found to be well tolerated in this age group, according to the study researchers.
On day 56, plaque reduction neutralisation tests in the three groups found that neutralising antibodies developed in,
95 percent participants in group 1
98 percent participants in group 2
98 percent participants in group 3
The neutralising antibody response were also found to be superior in children, compared to adults.
According to the study authors, whole inactive vaccines, like Covaxin, have a greater safety profile in young kids.
374 cases of adverse effects were recorded, however most of them were mild.
No serious adverse events, deaths, or withdrawals due to an adverse event were noted in either of the age groups.
Some local reactions like mild pain at the site of the injection were noted in all age groups. However, in all the age groups, only less than 50 percent of the participants had it.
Apart from pain, participants most commonly experienced mild-to-moderate fever, particularly after the first dose.
COVID Vaccines for Kids in India: Where Are We?
Although Covaxin has received Emergency Use Authorisation for use in children over the age of 6, currently, only children over the age of 15 are allowed to receive the vaccines in India.
The other vaccine that has been rolled out for kids is Corbevax — allowed only to kids over 12.
Another COVID vaccine, Covovax has been rolled out for kids over children over 12, but it is available only in private facilities.
According to a statement released by Bharat Biotech on 17 June, the study data was submitted to the Central Drugs Standard Control Organisation (CDSCO) back in October 2021 — when the vaccine was approved for kids over 6.
The peer reviewed study published in the Lancet, however, stenghtens the company's case for extending the vaccine's approval for an even younger age group.
"Safety of the vaccine is critical for children Covaxin has now proven data for safety and immunogenicity in children."Krishna Ella, Chairman and Managing Director, Bharat Biotech, in a statement
According to the statement, the same vaccine can be used for both adults and children, as the primary dose and as boosters, making it a 'universal' COVID vaccine.
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