Rama Rao congratulated the Hyderabad-based company’s Chairman and Managing Director Dr Krishna Ella, Joint Managing Director Suchitra Ella and the entire team of scientists on getting DCGI approval for Covaxin.
“Hyderabad continues to shine on as the vaccine capital because of the pursuit of excellence of scientists and innovative entrepreneurs,” tweeted KTR, as the minister is popularly known.
“Truly grateful for your belief in an indigenous technology and your persistent support,” replied Bharat Biotech.
The Drug Controller General of India (DCGI) on Sunday granted permission for emergency use of Covaxin. This came a day after the emergency use authorisation (EUA) approval recommendation by the subject expert committee (SEC) of Central Drugs Standards Control Organization (CDSCO).
Covaxin, India’s indigenous Covid vaccine, has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
According to the company, Covaxin is a highly purified and inactivated two-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
The phase III human clinical trials of Covaxin began in November. It is targeted for 26,000 volunteers across India. The company on Saturday announced that it enrolled 23,000 volunteers.
This is India’s first and only Phase III efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India.
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.
This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, a one-of-its-kind in the world.
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- Bharat Biotech gets permission to manufacture ‘Covaxin’ for sale [https://www.siasat.com/bharat-biotech-gets-permission-to-manufacture-covaxin-for-sale-2059704/]
- Serum, Bharat Biotech vaccines get restricted use approval from DCGI [https://www.business-standard.com/article/current-affairs/serum-bharat-biotech-vaccines-get-restricted-use-approval-from-dcgi-121010300692_1.html]
- Covaxin generated excellent safety data, says Bharat Biotech [https://morungexpress.com/covaxin-generated-excellent-safety-data-says-bharat-biotech]
- Covaxin generated excellent safety data, says Bharat Biotech [https://www.siasat.com/covaxin-generated-excellent-safety-data-says-bharat-biotech-2059726/]
- A decisive turning point: PM Modi on Covid vaccine approval [https://news.webindia123.com/news/Articles/India/20210103/3684909.html]
- All risks paid off, India proud: SII, Bharat Biotech on Covid vaccine nod [https://www.business-standard.com/article/current-affairs/all-risks-paid-off-india-proud-sii-bharat-biotech-on-covid-vaccine-nod-121010300552_1.html]
- ‘Decisive turning point’: PM hails approval to vaccines [https://morungexpress.com/decisive-turning-point-pm-hails-approval-to-vaccines]
- Bharat Biotech gets permission to manufacture ‘Covaxin’ for sale [https://morungexpress.com/bharat-biotech-gets-permission-to-manufacture-covaxin-for-sale]
- Oppn parties not proud of anything Indian, alleges Nadda as Cong and BJP spar over Covid Vaccine issue [https://www.udayavani.com/english-news/oppn-parties-not-proud-of-anything-indian-alleges-nadda-as-cong-and-bjp-spar-over-covid-vaccine-issue]