DCGI of India on Feb 21 gave emergency use approval to Biological E’s covid vaccine.
3rd vaccine is now available for youth ages 12 to 17
The country’s drug regulator has approved Biological E’s Corbevax vaccine for emergency use among children aged 12 to 17, having a third dose to the coronavirus vaccination campaign for minors. The government has already made an order for 5 million doses of Corbevax, which should be accessible in the states by the end of February.
After Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D, this is the third vaccine in this age group to obtain emergency use authorization. Only Covaxin is now provided to children above the age of 15.
The manufacturers of Covishield, the Serum Institute of India (SII), have also applied for regulatory approval for emergency use of Covovax in youth ages 12 to 17. When SII receives approval for Covovax, it will increase the availability of vaccines for children and may persuade the government to lower the age limit for Covid immunisation to 12 years old.
According to sources, the regulator’s expert committee on Covid vaccinations is expected to meet by the end of February.
The National Technical Advisory Group on Immunization (NTAGI) is analyzing data from the Omicron-driven third spike that struck the country in December and January. By the end of the month, the panel is expected to provide a recommendation on changing the vaccine plan.
Despite the fact that vaccination strategy is guided by scientific guidance, the scarcity of vaccines for children has hampered ambitions to expand the campaign. Covaxin’s monthly output is limited to 5-6 crore doses. Apart from youths (15-17), the vaccination is given to adults in two doses and as a ‘precaution dosage’ or third jab to healthcare/frontline workers and people over the age of 60.
Corbevax is a Covid vaccination that contains a receptor binding domain (RBD) protein subunit. It’s given in two doses of 0.5mL each, 28 days apart, intramuscularly. The vaccine should be kept between 2 and 8 degrees Celsius. It will be available in 0.5ml single shot packs, 5ml vials with 10 doses, and 10ml vials with 20 doses.
The approval was granted based on interim results from Biological E’s continuing phase II and III clinical investigation, the business announced on Monday. On December 28 of last year, the vaccine was approved for limited use in an emergency circumstance for adults. The Hyderabad-based firm was given permission to undertake phase II and III clinical studies on children in September 2021.
“Once properly vaccinated, youngsters can resume their hobbies and intellectual pursuits in schools and colleges without any worry,” Biological E managing director Mahima Datla said.
Apart from Covaxin, Zydus Cadila’s ZyCoV-D has also been approved for emergency use in persons aged 12 and up. However, it is not included in the programme for adolescent use.
Corbevax and Covovax have already been licenced for usage in adults above the age of 18 in an emergency situation.
While more than 97% of the adult population has received at least one dose, the newly licensed vaccines are only available to teenagers and as boosters. Vaccination of teenagers remains a government priority despite the reopening of academic institutions.
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