Bharat Biotech and Ocugen to bring Covaxin in US and Canada

Ocugen intends to continue working with FDA to evaluate regulatory pathways for the pediatric use of Covaxin.

Published On 2022-03-09 10:06 GMT   |   Update On 2022-03-09 10:06 GMT
Advertisement

New Delhi: Bharat Biotech a pioneering biotechnology company, on Monday said it, along with its partner Ocugen, is fully committed to bringing COVID-19 vaccine Covaxin in the US and Canada for all age groups. In a statement issued on Twitter, the Hyderabad-based vaccine major said Ocugen's Phase 2/3 Investigational Drug Application for Covaxin has been recently cleared by the US Food and Drug Administration(USFDA) for conducting clinical trials in adults.

Advertisement
"Ocugen intends to continue working with FDA to evaluate regulatory pathways for the pediatric use of Covaxin," it added.
On March 4, Ocugen Inc had announced that the USFDA has declined to issue a EUA for Covaxin for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals -- 2 to 18 years of age.
Last month, Bharat Biotech had announced that Covaxin would be assessed in the United States as a COVID-19 vaccine candidate.
Ocugen Inc, the company's US and Canadian partner for Covaxin, had stated earlier that the US health regulator has withdrawn its clinical hold to study the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US.
Covaxin (BBVI52), developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR), is a vaccine candidate currently under evaluation in the US.
In the US and Canada, Ocugen Inc is co-developing the Covaxin vaccine candidate for COVID-19. PTI MSS BAL.

Bharat Biotech is a pioneering biotechnology company. The company is known for its R&D and manufacturing capabilities. The company's mission is to deliver affordable, safe and high-quality vaccines and bio-therapeutics that help people prevail over diseases. The company seeks to lead innovation in biotechnology in order to lead the fight against disease with a focus on emerging markets.

Read Also - Bharat Biotech grants Rs 172 crore royalty to ICMR from Covaxin sale









Tags:    
Article Source : PTI

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News