Two More Vaccines Approved for 5-12 Years Age Group
NEW DELHI, April 26: The Drugs Controller General of India (DCGI) on Tuesday approved the emergency use authorisation for two anti-coronavirus vaccines in children between 5 and 12 years, senior officials in the Health Ministry confirmed.
Biological E’s Corbevax has been approved for administration in children between the ages of 5 and 12 and Bharat Biotech’s Covaxin has been approved for restricted use in emergency situations in children aged 6-12.
The move comes even as several State governments are now re-implementing COVID-19 protocols and Prime Minister Narendra Modi is scheduled to hold a meeting with Chief Ministers on April 27 on the emerging Covid situation.
Currently, Bharat Biotech’s inactivated whole virion vaccine is being administered in children aged 15-18, and Biological E’s protein sub-unit vaccine in children aged 12 -15 under a national COVID-19 immunisation programme.
On Tuesday, Gujarat-based Zydus Cadila’s two-dose Covid-19 vaccine was also granted emergency use authorisation for the 12 years and above population. At present, the three-dose version of the Zydus Cadila’s DNA vaccine is being used in the national immunization drive for the adult population. It is the first Covid-19 vaccine in the world that is built on a DNA platform and has been approved for commercial use. With this approval, this vaccine will now be administered on day 0 and day 28. Earlier, the vaccine was approved in a three dose regimen to be administered on day 0, day 28 and day 56.
With Tuesday’s decision, India will have an approved Covid-19 vaccine for 5 years and above. However, the final decision will be taken by the government’s expert body on vaccination to roll out the vaccination drive for this population. At present, India is using Corbevax for the 12-14 years age group and Covaxin for the adolescent population. Currently, the US and the UK are administering Pfizer’s mRNA vaccine for 5 years and above.
Dr. Sharvil Patel, MD, Zydus Lifesciences said: “The approval of a two-dose regimen for ZyCoV-D is a welcome development. This will increase the compliance of the vaccine and reduce the overall time required for vaccination to improve immunity against the virus. It will also help in administering the vaccine in a larger population in a shorter time which is always desirable in the midst of a pandemic.”
Approval by the DCGI for Corbevax and Covaxin is based on the recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO). Last week, the SEC reviewed the application of both the companies seeking emergency use authorisation. Covaxin was granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 on December 24, 2021. India began inoculating children aged 12-14 on March 16. “This latest move is aimed at covering the younger population and offering them vaccination protection against COVID,’’ said an official.
The DCGI has directed the vaccine maker to submit the safety data, including the data on the adverse events, with due analysis every 15 days for the first two months. Thereafter, Bharat Biotech has been asked to submit the data monthly for up to 5 months.
Taking to Twitter, Union Health Minister Mansukh Mandaviya said India’s fight against Covid has become stronger with the recent approvals. Covid-19 vaccinations for adolescents in the age group of 15-18 years commenced on January 3 this year. The drive was later expanded to include children aged above 12 years last month. India launched the vaccination drive for all people aged more than 45 years on April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May last year.
(Manas Dasgupta)
