Expert panel recommends Covaxin for 2-18-year-olds


The Hindu

Write Comment     |     E-Mail To a Friend     |     Facebook     |     Twitter     |     Print


Expert panel recommends Covaxin for 2-18-year-olds

Bharat Biotech’s COVID-19 vaccine Covaxin (BBV152) has been recommended for Emergency Use Authorisation (EUA) for 2-18- year-olds by the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO).

Covaxin is the country’s first indigenous, whole-virion, inactivated vaccine developed by Bharat Biotech in collaboration with the Indian Medical Research Council (ICMR) and the National Institute of Virology (NIV).

If given the green signal, it will emerge as the first COVID-19 vaccine globally to be used for vaccinating children as young as 2 years. In a statement issued on Tuesday, the company said it had submitted data from clinical trials in the 2-18 age group to the CDSCO. The positive recommendations, after due review by the SEC, were submitted to the Drugs Controller General of India (DCGI).

A senior Central Government official stated that the Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 in September and submitted the trial data. The trials were done on the age groups of 2-6, 6-12 and 12 -18.

Children peep inside a tent where people receive a dose of Covaxin, during a vaccination drive organised by an NGO at an under-construction flyover in New Delhi on August 31, 2021. An expert panel on October 12, 2021 recommended emergency use authorisation for Covaxin in the 2 to 18 age group.

Experts maintained that two doses of Covaxin could be administered to children within a gap of 28 days. For adults, the government has set 4-6 weeks between the two shots.

“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group,” the Bharat Biotech statement claimed. The company was awaiting further regulatory approvals from the CDSCO prior to product launch and market availability of the vaccine for children.

Dr. Shuchin Bajaj, founder and director, Ujala Cygnus Group of Hospitals, highlighted, “India has always been known as a vaccine and a medicine drug producer but never a medicine or a drug developer. This is the first time that a vaccine has been entirely developed and produced in India and its efficacy and safety have been proven to be high so much so that it is now being trialled in children.”

The vaccine would lead to protection of children. “Currently, adults have been vaccinated, but children have been left exposed to the virus. This vaccine will bring about a positive change,” he stressed.

Dr. Bipin Singh, assistant professor, School of Engineering & Technology, BML Munjal University (BMU), noted that the emergency use approval of the vaccine for children aged 2-18 years was promising. It would have been better if the vaccine was first approved for children within the age bracket of 10-18 years. The recommendations were based on a larger and diverse pool of clinical trails data and long-term evaluations, he pointed out.

Dr. (Maj.) Manish Mannan, head of department, Pediatrics and Neonatology, Paras Hospitals, Gurugram, speaking about the availability of the vaccine in the private sector observed that it would be a watch and wait scenario.

“The DCGI has to give its final approval and then vaccination has to begin. As doctors working with children, we will be watching the data closely. I would go slow into the vaccination and will see how the data comes in on the phase four of the trial or when actually the vaccine is being given to children in various parts of the country and various centres. We have to see the response. Even though the number of children involved in the clinical trial is a small number, the results have been encouraging. As the vaccination process starts, we will see how it goes and then we will go ahead and consider using this vaccine,” he remarked.

The World Health Organisation is expected to take a call on Bharat Biotech’s Emergency Use Listing (EUL) application for Covaxin soon.

Write your Comments on this Article
Your Name
Native Place / Place of Residence
Your E-mail
Your Comment   You have characters left.
Security Validation
Enter the characters in the image above
    
Disclaimer: Please write your correct name and email address. Kindly do not post any personal, abusive, defamatory, infringing, obscene, indecent, discriminatory or unlawful or similar comments. Kemmannu.com will not be responsible for any defamatory message posted under this article.
Please note that under 66A of the IT Act, sending offensive or menacing messages through electronic communication service and sending false messages to cheat, mislead or deceive people or to cause annoyance to them is punishable. It is obligatory on kemmannu.com to provide the IP address and other details of senders of such comments, to the authority concerned upon request. Hence, sending offensive comments using kemmannu.com will be purely at your own risk, and in no way will Kemmannu.com be held responsible.
Similarly, Kemmannu.com reserves the right to edit / block / delete the messages without notice any content received from readers.




Mangalorean Teen Feryl Rodrigues Shines as May Que
View More

Final Journey of John Henry Almeida (71 years) | LIVE from UdyavaraFinal Journey of John Henry Almeida (71 years) | LIVE from Udyavara
Final Journey of Mrs. Severine Pais (85 years) | LIVE from Milagres, Kallianpur, UdupiFinal Journey of Mrs. Severine Pais (85 years) | LIVE from Milagres, Kallianpur, Udupi
Final Journey of Mrs Lennie Saldanha (89 years) | LIVE from Kemmannu | UdupiFinal Journey of Mrs Lennie Saldanha (89 years) | LIVE from Kemmannu | Udupi
Final Journey of Zita Lewis (77 years) | LIVE from Kallianpur, UdupiFinal Journey of Zita Lewis (77 years) | LIVE from Kallianpur, Udupi
Final Journey of Henry Andrade (83 years) | LIVE from KemmannuFinal Journey of Henry Andrade (83 years) | LIVE from Kemmannu
Final Journey of Mr. Leo Britto (65 years) | LIVE from Mother of Sorrows Church, UdupiFinal Journey of Mr. Leo Britto (65 years) | LIVE from Mother of Sorrows Church, Udupi
Mount Rosary Church - Rozaricho Gaanch May 2025 IssueMount Rosary Church - Rozaricho Gaanch May 2025 Issue
Final Journey of Juliana Machado (93 years) | LIVE from Udyavara | UdupiFinal Journey of Juliana Machado (93 years) | LIVE from Udyavara | Udupi
Final Journey of Charles Pereira (78 years) | LIVE from KemmannuFinal Journey of Charles Pereira (78 years) | LIVE from Kemmannu
Milarchi Laram, Milagres Cathedral, Kallianpur, Diocese of Udupi, Bulletin - April 2025Milarchi Laram, Milagres Cathedral, Kallianpur, Diocese of Udupi, Bulletin - April 2025
Holy Saturday | St. Theresa Church, KemmannuHoly Saturday | St. Theresa Church, Kemmannu
Final Journey of Albert Lewis (85years) | LIVE From St Theresa’s Church Kemmannu | UdupiFinal Journey of Albert Lewis (85years) | LIVE From St Theresa’s Church Kemmannu | Udupi
Final Journey of Bernard G D’Souza | LIVE from MoodubelleFinal Journey of Bernard G D’Souza | LIVE from Moodubelle
Earth Angels Kemmannu Unite: Supporting Asha Fernandes on Women’s DayEarth Angels Kemmannu Unite: Supporting Asha Fernandes on Women’s Day
Final Journey of Joseph Peter Fernandes (64 years) | LIVE From Milagres, Kallianpur, UdupiFinal Journey of Joseph Peter Fernandes (64 years) | LIVE From Milagres, Kallianpur, Udupi
Milagres Cathedral, Kallianpur, Udupi - Parish Bulletin - January 2025 IssueMilagres Cathedral, Kallianpur, Udupi - Parish Bulletin - January 2025 Issue
Rozaricho Gaanch 2024 December Issue - Mount Rosary Church, SanthekatteRozaricho Gaanch 2024 December Issue - Mount Rosary Church, Santhekatte
Land/Houses for Sale in Kaup, Manipal, Kallianpur, Santhekatte, Uppor, Nejar, Kemmannu, Malpe, Ambalpady.Land/Houses  for Sale in Kaup, Manipal, Kallianpur, Santhekatte, Uppor, Nejar, Kemmannu, Malpe, Ambalpady.
Naturya - Taste of Namma Udupi - Order NOWNaturya - Taste of Namma Udupi - Order NOW
Focus Studio, Near Hotel Kidiyoor, UdupiFocus Studio, Near Hotel Kidiyoor, Udupi