The results of Phase 3 clinical trials
Covaxin has shown 77.8% efficacy in the Phase 3 trials conducted across India, a source said.
The Subject Expert Committee (SEC) has reviewed Bharat Biotech’s data, and this will now be sent to the drug controller general of India for approval, the source further said.
Bharat Biotech will also will hold a ‘pre-submission’ meeting with the WHO regarding the approval of its Covid-19 vaccine Covaxin on June 23.
In May, Bharat Biotech said its Emergency Use Listing ( EUL) application had been submitted to WHO, Geneva, and regulatory approvals are expected between July and September.
The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality, and a risk management plan.
An emergency approval from the WHO will allow the company to export its vaccines.
As an inactivated vaccine, Covaxin uses a more traditional technology that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 was isolated by India’s National Institute of Virology and used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with an aluminium-based adjuvant.
The vaccine is produced with Bharat Biotech’s in-house vero cell manufacturing platform that has the capacity to deliver about 300 million doses. The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm in collaboration with Government of Odisha is establishing another facility at Odisha Biotech Park in Bhubaneswar to commence Covaxin production by June 2022. Besides this, they are also exploring global tie-ups for Covaxin manufacturing.