COVAXIN phase 3 trial data to be made public in July 2021
COVAXIN phase 3 trial data: As per the interim analysis of the Covaxin trials, the vaccine's overall efficacy is 78 percent against symptomatic disease and 100 percent against hospitalizations.
Hyderabad-based vaccine manufacturer Bharat Biotech informed on June 9, 2-21 that it will be publishing the complete data of the phase 3 trials of its vaccine in July 2021 and then apply for the full licensure of COVAXIN.
The manufacturer stated that the phase 3 trial data of Covaxin will be first submitted to the Central Drugs Standard Control Organisation (CDSCO) and then it will be submitted to peer-reviewed journals with a publication timeline of 3 months.
This means that the full data of the phase 3 vaccine trials will be made open to the public by July. Once the data is made available, Bharat Biotech will apply for full licensure for COVAXIN.
As per the interim analysis of the Covaxin trials, the vaccine's overall efficacy is 78 percent against symptomatic disease and 100 percent against hospitalizations.
What is vaccine efficacy?
• The vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use.
• As per Bharat Biotech, the whole virus-inactivated vaccines have demonstrated one of the best safety records globally.
• In a preliminary pre- peer-reviewed study about vaccine efficacy report, the company had clarified that it has undergone and will continue to undergo the most intensive safety and efficacy monitoring in Indian vaccines history.
• The company added saying that Covaxin will even undergo the phase 4 trials to check the real-world effectiveness of the vaccines to ensure its vaccine meets every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.
How was Covaxin developed?
Covaxin is an inactivated virus-based COVID-19 vaccine, which was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology (NIV).
At first, a sample of SARS-CoV-2 was isolated by NIV India and then it was used to grow large quantities of the virus using Vero cells. The viruses were then soaked in beta-propiolactone, which deactivates them by binding to their genes, leaving other viral particles intact. The inactivated viruses are then mixed with an aluminum-based adjuvant.
Covaxin is one of the three COVID-19 vaccines currently approved for emergency use in India. It was approved in January without having carried out phase 3 trials at the time. The company released interim trial data in April that showed the vaccine was very effective.
The phase 3 trials of Covaxin had enrolled around 25,800 participants between the age of 18-98 years. The analysis was conducted 14 days after the second dose.