DCGI clears COVAXIN, Corbevax for children aged 6-12, 5-12 years
In a significant move, the Drugs Controller General of India (DCGI) on Tuesday cleared two COVID-19 vaccines for use in children aged between five and 12 years. The country's apex drugs regulator has granted emergency use authorization to Bharat Biotech's COVAXIN for administration to kids in the 6-12 years age group and Biological E's Corbevax for the 5-12 age group. Here are more details.
- The development comes as India witnesses a gradual increase in COVID-19 cases, especially in Delhi, Haryana, Uttar Pradesh, Mizoram, and Maharashtra.
- The move assumes significance as a rise in infections in children has been observed in recent weeks.
- To recall, the Centre launched vaccinations for adolescents aged 15-18 years on January 3, 2021. Last month, the drive was expanded to children aged 12-14 years.
The DCGI's move comes after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) sent its recommendations to the drugs regulator, according to reports. The SEC on COVID-19 had reviewed the EUA applications submitted by Bharat Biotech and Biological E for use in 6-12 years and 5-12 years age groups, respectively, last week.
The DCGI has reportedly asked Bharat Biotech to submit safety data, including information on any adverse events, with due analysis every 15 days for the initial two months. Later, the COVAXIN maker will be required to submit data on a monthly basis for five months.
To note, Bharat Biotech's COVAXIN vaccine is currently being administered in the country to adolescents aged between 15 to 18 years. It is also the first anti-COVID-19 vaccine that has been developed indigenously in India. Meanwhile, Biological E's Corbevax, which is another indigenously developed vaccine, is being provided to those between the ages of 12 and 14 at present.
Meanwhile, Zydus Cadila's two-dose ZycovD vaccine was also approved for children over the age of 12 on Tuesday. Until Tuesday, Corbevax was the only vaccine approved for children aged 12 to 14, while Serum Institute of India's Covovax received emergency approval for the 12-17 age group. Union Health Minister Mansukh Mandaviya tweeted on Tuesday that the recent vaccine approvals have strengthened India's COVID-19 fight.
India on Tuesday reported 2,483 new COVID-19 cases. The active caseload currently stands at 15,636, accounting for 0.04% of the total cases. On Tuesday, India also reported 1,399 COVID-19-related fatalities. Of these, 1,347 deaths (backlog) were reconciled by Assam, reflecting the number of COVID-19-positive patients who died due to other reasons. Meanwhile, the country's COVID-19 recovery rate stood at 98.75%.
