Bharat Biotech’s COVAXIN achieved another big milestone today. The Made in India COVID19 vaccine COVAXIN®️ has received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities.
The approval received is from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of COVAXIN®️. The certificate of GMP is now listed on the EudraGMDP database, which is the database of the European Community of manufacturing authorizations and certificates of the good manufacturing practice.
Bharat Biotech intends to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.
With this approval, Bharat Biotech has achieved another significant milestone in innovating and manufacturing vaccines at global quality standards and moving forward in the ongoing fight against the Covid-19 pandemic. The recognition complements our commitment of driving world-class innovation and being a frontrunner in the research and development of vaccines.
COVAXIN manufacturing news update
Covaxin, a whole-virion inactivated SARS-CoV-2 vaccine used for mass immunization in India, showed a 65.2 per cent protection against the Delta variant in a double-blind, randomized, multicentre, phase 3 clinical trial.
Covaxin demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the B.1.617.2 Delta variant, Bharat Biotech had said while concluding the final analysis of Covaxin efficacy from Phase-3 trials on July 3.
COVAXIN effective against Delta Plus Variant – ICMR Study
COVAXIN, India’s first indigenous vaccine to fight Covid-19, is effective against the Delta Plus variant of coronavirus, a study conducted by Indian Council of Medical Research (ICMR) has said, according to news agency ANI. Covaxin has been developed by Bharat Biotech, in collaboration with ICMR.
Delta Plus is a mutated form of the Delta variant, first discovered in India. It is characterised by increased transmissibility. Last week, Union Science and Technology Minister Jitendra Singh said in Parliament that 70 cases of the Delta Plus variant were found by INSACOG, a group of 28 laboratories involved in genome sequencing.
In July, the Hyderabad-based company released data from the final analysis of Covaxin and said that it demonstrated overall efficacy of 77.8 per cent against symptomatic infection. It also said that Covaxin has now received emergency use authorisations (EUAs) in 16 countries including, Brazil, India, Philippines, Iran, Mexico, with EUAs in process in 50 countries worldwide.
What is COVAXIN
COVAXIN®, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.