Bharat Biotech has been asked to provide additional data for administering Covaxin to children aged between 2 and 12 years by the Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI).
This comes after the Subject Expert Committee discussed recommendations for the emergency use of Bharat Biotech's COVID-19 vaccine Covaxin in children aged between 2 and 12 years. There has been no recommendation so far.
The SEC has reportedly recommended restricted emergency use of Biological E's COVID-19 vaccine, Corbevax, in children aged 5-12 years after a meeting on April 21, 2022. The vaccine will now require a go-ahead from the DGCI for its formal emergency use authorisation in the age group. The vaccine is currently being administered to children in the age group of 12-14 years.
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Covaxin approved for emergency use on children above 12 years
Bharat Biotech's Covaxin had been granted emergency use authorisation by DGCI on December 25, 2021 for emergency use on children above 12 years with certain conditions after the recommendation of SEC experts and the submission of additional safety data.
The DGCI had approved usage of Covaxin in children above the age of 12 years with the same dose schedule of 0&28 days.
COVAXIN® receives approval for emergency use in Children 12 - 18 years of age.#covaxin #COVID19 #covaxinapproval#childrensafety #BharatBiotech #vaccine #safety #pandemic pic.twitter.com/3LswUG8QU4
— BharatBiotech (@BharatBiotech) December 25, 2021
Read Also: Bharat Biotech's Covaxin gets DGCI approval for emergency use on children above 12 years
Covaxin Pricing
Bharat Biotech released an official statement on April 9, 2022 announcing revision of Covaxin's price from Rs 1200 to Rs 225 per dose. The company requested the private hospitals to provide the vaccine at the revised rate effective from April 10, 2022. The price differential of any existing stock of Covaxin will be compensation with additional doses.
WHO suspends COVID-19 vaccine supply
WHO on April 2,2022 announced the suspension of the supply of Bharat Biotech's Covaxin through UN procurement agencies recommended that countries using the vaccine take action as appropriate. The suspension was in response to the outcome of a WHO inspection conducted earlier in March and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP).
Bharat Biotech announced that it is committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to DGCI and WHO. The company said that it will suspend Covaxin for export as a precautionary measure.
However, there are no risks associated with the safety of the vaccine. WHO assured that the available data indicates that the vaccine is effective and no safety concerns exist.
Read Also: Bharat Biotech to suspend Covaxin production for export, rectify issues raised by WHO
CovaxinCovaxin is India's first indigenous COVID-19 vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). It is a two-dose vaccine that is administered in a gap of 28 days. It is an inactivated vaccine that has been developed using Whole-Virion Inactivated Vero Cell-derived platform technology. Inactivated vaccines do not replicate and are unlikely to revert and cause pathological effects. What are inactivated vaccines?Inactivated vaccines contain dead viruses and are incapable of infecting people but will be able to instruct the immune system to build a defensive reaction against an infection. Inactivated vaccines have been around for decades, as a number of vaccines for diseases including polio, seasonal influenza, rabies and Japanese Encephalitis use the same technology. Covaxin also has immune-potentiators, also known as vaccine adjuvants, which are added to the vaccine to increase and boost its immunogenicity. |
Background
The central government began the vaccination drive for children aged between 15-18 years on January 3, 2022. The drive was later expanded to include children aged between 12-14 years on March 16. However, the children between 12-14 years are being administered Corbevax.
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