Covaxin, India’s indigenous Covid-19 vaccine, has reached 30 cities in the past 30 days, said the vaccine manufacturer Bharat Biotech in a statement on Tuesday. Among 30 cities that have received the Covaxin doses include Delhi, Kolkata, Mumbai, Chennai, Bengaluru, Kochi and Amritsar.
Covaxin is one of the three vaccines that the DGCI has cleared for emergency use in India. The two others are Covishield and Sputnik V. While Covishield is the local version of Oxford-AstraZeneca COVID-19 vaccine and being manufactured by Pune-based Serum Institute of India, Sputnik V is a Russian drug.
“COVAXIN reaches 30 cities within 30 day. All our employees are committed, working 24×7 through lockdowns for the country’s immunisation – pls send your prayers to their families, some are still quarantined and off work (sic),” Bharat Biotech Co-founder and joint MD Suchitra Ella said in a tweet.
The company earlier informed that it is planning to produce additional 200 million doses of COVID-19 vaccine amid concerns over the low rate of vaccination in the country. The Hyderabad-based firm said it will utilise the Ankleshwar-based production facility of its wholly-owned subsidiary Chiron Behring Vaccines to add another 200 million doses of Covaxin.
“The company plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety,” the company said in a statement.
Bharat Biotech aims USA trial
Bharat Biotech had on Monday said that the company is also in advanced negotiations with the US Food and Drug Administration (FDA) for commencing phase-III clinical trials of vaccine in the country. Ocugen, Bharat Biotech’s American partner for COVID-19 vaccine Covaxin, has submitted a “Master File” to the US Food and Drug Administration prior to seeking an emergency use authorisation in that country.
“The company is currently evaluating the clinical and regulatory path for COVAXIN in the United States including obtaining Emergency Use Authorization (EUA) from the US FDA. Also, eventually biologic license application (BLA) approval in the United States, as well as the company’s commercialization strategy, if authorized or approved,” Ocugen said in a recent regulatory filing.
Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input prior to a planned EUA submission. The company is currently awaiting additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission.
Meanwhile, Bharat Biotech is also aiming to obtain the World Health Organisation (WHO) approval for the drug. The company has already submitted 90 per cent of documents to the WHO for emergency use nod.