India's Drug Regulator approved India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, Corbevax, for restricted use in emergency situation.
Highlights
- Government yet to decide on which segment of beneficiaries this new vaccine would administer to
- The HLL Lifecare Limited has issued the supply order of Corbevax to Biological E in January-end
- Corbevax is administered through an intramuscular route with two doses scheduled 28 days apart
The Centre has placed a purchase order with Biological E for five crore doses of Covid vaccine Corbevax each costing Rs 145 excluding taxes, official sources said on Saturday. The government is yet to decide on which segment of beneficiaries this new vaccine would be administered.
However, according to sources, discussions are underway in technical groups and in the Health Ministry's immunisation division about expanding the scope of the precaution doses which are currently being given to healthcare and frontline workers, and comorbid senior citizens. The HLL Lifecare Limited, a public sector undertaking, has issued the supply order of Corbevax to Biological E in January-end on behalf of the Union Health Ministry.
According to the order, the Hyderabad-based company is expected to provide the supplies in February. "The cost implication of five crore dosed of Corbevax at the rate of Rs 145 per dose plus GST as applicable come to Rs 725 plus GST as applicable. In this regard, it is also stated that Rs 1,500 crore has been released as advance vide sanction order dated June 2, 2021, to HLL Lifecare Limited for procurement of Corbevax from Biological E Limited," the order stated.
The government has told Parliament that any decision on expanding the list of eligible beneficiaries for precaution dose of COVID-19 vaccines and vaccination of children below 15 years will be in accordance with the recommendations of the NTAGI based on a review of the available scientific evidence. India's Drug Regulator approved India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, Corbevax, for restricted use in emergency situation.
Corbevax is administered through an intramuscular route with two doses scheduled 28 days apart and is stored between 2 degrees Celsius to 8 degrees Celsius. It is presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack. The company has conducted phase 1/2, 2/3 clinical trials of its COVID-19 vaccine in the country. It has also conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, the health ministry had stated.
The Emergency Use Authorization proposal for Corbevax was reviewed by CDSCO in consultation with SEC on December 10 and 27 last year. After deliberation, it recommended for grant of permission for restricted use in emergency situation to manufacture and market Corbevax in 18 years and above subject to various regulatory conditions. The recommendations were accepted by the Drugs Controller General of India subsequently.
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