Covaxin, the coronavirus vaccine developed by Hyderabad-based Bharat Biotech, has been recommended for “restricted emergency use, subject to multiple regulatory conditionalities” by a government-appointed panel of experts, which submitted its findings to the Drugs Controller General of India on Saturday evening.
The DCGI will take the final call on approving rollout of the vaccine in the country.
Dr Savita Verma, a pharmacology professor from Haryana’s PGIMS who is working on the vaccine, told NDTV that around 10 million doses of Covaxin are ready to roll out.
Bharat Biotech has yet to release efficacy data – to show how effective the drug is in protecting against the coronavirus. However, interim findings of Phase I trials showed the drug induced an immune response and registered no serious side effects. Data from Phase II trials showed “tolerable safety outcomes”, suggesting antibodies may persist for six to 12 months.
The vaccine, administered on an accelerated scheduled of two doses two weeks apart (rather than four), induced a neutralising antibody (an immune response) and was well-tolerated in all dose groups with no vaccine-related serious adverse events, documents accessed by NDTV showed.
Emergency use approval of a drug – which is what has been recommended by the panel – is usually granted if there is sufficient evidence to suggest the drug is safe and effective.
The recommendation comes a day after the panel sent another drug – Covishield, developed by AstraZeneca and Oxford University, and manufactured by Pune’s Serum Institute – for approval.
A third vaccine – developed by American pharma giant Pfizer – had also applied for emergency fuse authorisation and is currently being reviewed by the panel.
The government on Saturday conducted a day-long trial run of the vaccine delivery system to check for potential problems once a vaccine is made available. The Health Ministry said dry runs were held in 116 districts, with nearly one lakh personnel undergoing necessary training.
The health Minister, Dr Harsh Vardhan, said this morning that there should be no misconceptions about the safety of the coronavirus vaccines that India plans to use. Dr Vardhan also reiterated that there was no evidence to suggest the existing vaccines could not protect against mutated strains of the virus that were first detected in the United Kingdom and South Africa.