Corbevax may seek emergency use authorisation by November

Last month, the company sought permission from India’s drugs regulator to conduct the phase-3 clinical trial for Corbevax as a single booster dose for those who have been fully vaccinated with either Covishield or Covaxin

Hyderabad based vaccine manufacturer Biological-E is likely to declare phase 2/3 trial results of its anti Covid-19 vaccine Corbevax this month, according to people familiar with the development.

The vaccine being developed by Biological-E is a RBD protein sub-unit vaccine. (HT Photo)

“After interim phase 3 trial data is collated, the company might approach the drugs regulator to seek emergency use authorisation for Corbevax this month itself. It is likely to happen very soon,” the person said, adding the government’s Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, has cleared a batch last week after quality testing, paving the way for advance manufacturing of the vaccine.

In June, this year, the Centre finalised arrangements with the company to reserve 300 million Corbevax doses, Union ministry of health and family welfare announced, even though its phase I/II trial results were yet to be made public and the phase III trial was still underway.

“These vaccine doses will be manufactured and stockpiled by M/s Biological-E from August-December 2021. For this purpose, the Union Ministry of Health would be making an advance payment of ₹1,500 crore to M/s Biological-E,” said the ministry in a statement at the time the deal was finalised.

The vaccine being developed by Biological-E is a RBD protein sub-unit vaccine. According to people familiar with the matter, the company sought an advance from the Central government to develop its Covid-19 vaccine candidate, and after duly examining its proposal, the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) recommended it for approval to the health ministry. The ministry in turn also gave its consent, and went for the advance purchase. The doses were to be supplied by December.

The company, last month, also sought permission from India’s drugs regulator to conduct the phase-3 clinical trial for Corbevax as a single booster dose for those who have been fully vaccinated with either Covishield or Covaxin.

Serum Institute of India locally manufactures the Oxford-AstraZeneca Covid-19 vaccine under the brand name Covishield, and Covaxin is manufactured by Bharat Biotech in collaboration with the Indian Council of Medical research.