Corbevax is likely to get approval for kids between 5 to 11 years age group
With the surge in the COVID-19 cases in the National Capital Region (NCR) in the past week, an expert panel of India's central drug authority has recommended granting emergency use of Biological E's COVID-19 vaccine Corbevax for kids between 5 to 11 years age group. The Subject Expert Committee (SEC) on COVID-19 vaccines has put forth the proposal with certain conditions before the Drugs Controller General of India (DCGI), who is likely to take up the recommendation for formal approval in the next few days.
What you need to know about Biological E's COVID-19 vaccine
Biological E is a Hyderabad-based vaccine manufacturer that has developed Corbevax. It is India's third homegrown vaccine after Bharat Biotech's Covaxin and Zydus Cadila's ZyCoV-D, which received emergency approval for use in children aged 12 to 18 years. The same vaccine also got the DCGI nod for restricted use in emergencies among adults on December 28, 2021.
The SEC reviewed Biological E's application on April 11 and asked for updated safety data 2-3 months after the second dose in the proposed 5 to 11 age group for emergency use. The vaccine manufacturer was also asked to submit the immunogenicity data and virus neutralising antibody data against a variant of concern. After reviewing the application, the committee noted that the interim safety and immunogenicity data of Phase 2/3 clinical trial in this age group is comparable to that of higher age groups.
Read more: Why more children in the age of 5-11 are getting very sick with COVID in the US
How does the vaccine work
Corbevax is the country's first indigenously developed Receptor Binding Domain (RBD) Protein built on the traditional subunit vaccine platform against the contagious virus. The RBD is the part of the spike protein of the SARS-CoV-2 and attaches itself to the host cells after coming in contact with it. The vaccine contains an antigen developed by the Texas Children’s Hospital Centre for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team.
Cost of Corbevax shot
The Corbevax shot is currently being administered to kids in the 12-14 years age group. The Covaxin shot is for those falling in the 15-18 years group.
The cost of Corbevax for children between the 12 to 14 age group currently costs Rs 990 in the private hospitals and Rs 145 at government facilities. Its two doses are administered through the intramuscular route in the period 28 days apart.
Other vaccine that may get approval in the 5-11 age category
In the meeting, the expert committee on COVID-19 also sought more data from Bharat Biotech to review its emergency use authorisation (EUA) application for use of Covaxin on kids aged 2 to 11 years. Depending on the report submitted by the pharmaceutical company the committee may take a decision in the coming months.
Vaccines that are being administered across the globe
The US approved the Pfizer-BioNTech vaccine for children aged 5-17 years. Even in the UK, the same vaccine has been granted permission for children aged 5 to 15. The EU's European Medicines Agency (EMA) has approved Moderna's Spikevax vaccine for children aged 6 to 11.
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