COVAXIN – India’s COVID-19 vaccine maker Bharat Biotech shared two significant updates that include details about augmenting vaccine production and significant advancement on covid-19 child vaccine against coronavirus.
- COVAXIN production would touch 55 million doses next month as against 35 million in September.
- Pediatric COVAXIN just completed phase 2/3 trials. The data analysis is going on
Talking on the sidelines of Pharmaceutical Export Promotion Council of India (Pharmexcil) conference held on Tuesday ( Today) in Hyderabad, Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech shared the advancements in these areas.
Bharat Biotech has completed the Phase 2 and 3 clinical trials of coronavirus vaccine, Covaxin for use in the age group of 2 to 18 years. The Hyderabad-based vaccine maker is expected to submit the data by next week to the DCGI.
Speaking to reporters on Tuesday, Dr. Ella, also shared an update about said Covaxin production. He said it would touch 55 million doses next month as against 35 million in September.
Bharat Biotech Covid-19 intranasal Phase 2 trials is expected to be over by next month.
“Paediatric Covaxin just completed phase 2/3 trials. The data analysis is going on. We will be submitting the data ( to the regulator) by next week. The number of subjects ( volunteers) is touching 1000,” the founder and chairman of Bharat Biotech said.
Intranasal immunization can create an immune response in the nose, which is the point of entry for the virus—thereby protecting against the disease, infection, and transmission also, he noted.
As per Ella, the intranasal vaccine trials are conducted on three cohorts in which one group is administered Covaxin as the first dose and intranasal as the second. Similarly intranasal-intranasal for the second group and Intranasal- Covaxin for the third cohort, 28 days apart.
He said the trials will be conducted on about 650 volunteers. On the production levels of Covaxin, Ella said 100 million doses per month can be possible if the other manufacturing partners are fully geared up with safety and other parameters are in place.
WHO approval update for COVAXIN
Earlier this week the company shared “We have responded to any clarifications sought by #WHO and are awaiting further feedback . As a responsible manufacturer with past approvals for our other #vaccines , we do not find it appropriate to speculate or comment on approval process & its timelines. “
COVAXIN® clinical trial data was fully Compiled & available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July.
Mrs. Suchitra Ella, Joint Managing Director in her tweet wrote: Our vaccines will prove yet again , are world class. india supply’s billions of doses of many vaccines world over. Covid 19 taught us enuf life lessons, vaccines must not be entry barriers for nations, when NRA approved & licensed.Flag of Indiacrossed 800 Mn doses, no small achievement.