Bharat Biotech’s COVID-19 vaccine Covaxin has got the government’s go-ahead for phase 2 and 3 clinical trials in children and teenagers aged between 2 to 18 years, official sources confirmed.
The trial will take place on 525 volunteers at various hospitals, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences in Nagpur.
The approval is expected to ultimately pave the way for reopening schools in the country which will be a huge victory in the war against Covid-19 and help bring back life to normal.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday after detailed deliberation, approved the Bharat Biotech proposal for conducting phase 2 and 3 clinical trials of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group. The approval is subject to the condition that the firm should submit the interim safety data of phase 2 clinical trial along with the data safety monitoring board’s recommendations to the CDSCO before proceeding to phase 3 part of the study,” a senior official said.
A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from one or more ongoing clinical trials on a regular basis and advise the sponsor about: The continued safety of the trial participants.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India’s ongoing COVID-19 vaccination drive.
American experience
The approval also comes a day after the United States on Monday authorised the Pfizer-BioNTech Covid-19 vaccine for children aged 12 to 15 years old. The US decision is likely to pave the way for other countries to follow suit.
The US Food and Drug Administration (USFDA) had earlier granted an emergency use authorisation for the Pfizer vaccine for individuals aged 16 and older.
The head of the European Medicines Agency said Monday that BioNTech/Pfizer's jab against Covid-19 soon could be approved for 12- to 15-year-olds in the EU, as well, perhaps as early as this month.
The USFDA declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers aged 12 to 15. The study found no cases of COVID-19 among fully vaccinated adolescents compared to 18 among children given dummy shots.
Researchers found the kids developed higher levels of coronavirus-fighting antibodies than earlier studies measured in young adults.
The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.
Pfizer’s testing in adolescents “met our rigorous standards,” said FDA vaccine chief Dr. Peter Marks. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”
Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.
