New Delhi: Hyderabad-based Bharat Biotech has submitted Phase III trial information for the Covaxin Covid-19 vaccine to the DCGI (Drug Controller General of India).
The drug regulator's SEC (topic professional committee) is expected to meet today to debate the outcomes.
The firm is also expected to carryout a 'pre-submission' assembly on Wednesday with the World Health Organization for worldwide emergency use itemizing (EUL) of its vaccine.
A 'pre-submission' assembly will present a possibility to obtain steering from WHO authorities earlier than ultimate submission of the information in a recognised, peer-reviewed journal.EULs contain rigorous evaluation of medical trial information – in addition to information on security, efficacy and high quality – and a threat administration plan.
An EUL from WHO will permit Bharat Biotech to export its vaccines and allow simpler worldwide journey for Indian residents vaccinated with Covaxin, which is not yet recognised as a certified COVID-19 vaccine by many foreign governments.
In March, Bharat Biotech had released a "first interim evaluation" of Phase III trial results, and said it: "demonstrated 81 per cent interim efficacy in stopping COVID-19 in these without prior infection after the second dose."
Earlier this month, the company said it would publish trial results in July and apply for a full licence.
"it is critical to understand that Phase III data will first be submitted to CDSCO (the Central Drugs Standard Control Organisation)… followed by peer-reviewed journals with a timeline of approximately three months for publication" said the company in a statement.
Meanwhile, Phase II/III trials on children – on 525 "wholesome volunteers" between two and 18 years old – began this month amid concerns that a third wave could possibly affect kids, and the need to eventually expand vaccination to all sections of the population.
These trials are to take place at various sites across the country, including AIIMS in Delhi and Patna, and the Meditrina Institute of Medical Sciences in Nagpur.
Apart from Covaxin, the AstraZeneca-Oxford University vaccine (made and bought in India as Covishield) and Russia's Sputnik V are the other shots available in India.The authorities have stated it's working with US pharma giants Pfizer and Moderna to use their vaccines as well to fight covid-19.