FDA removes hold on clinical trial for phase 2,3 for COVAXIN-BBV152 says Ocugen

PTI, May 24, 2022, 9:43 AM IST

The US Food and Drug Administration (FDA) released the clinical hold on Ocugen’s Phase 2, 3 clinical studies for COVAXINTM on Monday, according to the firm (BBV152). Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen Inc., stated, “We’re overjoyed that COVAXIN, our whole virus inactivated COVID-19 vaccine candidate, may now move forward with clinical studies. We feel that providing an additional, distinct vaccine option remains a top goal.”

Dr Musunuri thanked the clinical trial partners and site collaborators for their ongoing support. “Ocugen will now work with study sites to fully resume this clinical development program immediately,” he added.

He told that COVAXIN™ (BBVI52) is an investigational vaccine candidate product in the US. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), National Institute of Virology (NIV), reported the Globe News Wire. The vaccine is a highly purified and inactivated vaccine that is manufactured using a Vero cell manufacturing platform, he said.

Adding on, Dr Musunuri said that with more than 350 million doses having been administered to adults outside the US, COVAXIN is currently approved for adults in India and authorized for emergency use in 25 countries. Applications for emergency use authorization are pending in more than 60 other countries.

The vaccine is listed by the World Health Organization (WHO) as authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN. The trade name, COVAXIN, has not been evaluated by the FDA, reported the Globe News Wire. The biotechnology company, Ocugen is focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines that improve health and offer hope for people and global communities, he told.

Dr. Munusuri said, “We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs.”

(With inputs from ANI)

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Udaipur killing: Cong alleges one of main accused ‘BJP member’

Retired Karnataka SP gets 4 years in jail in disproportionate assets case

Bantwal: Several injured in head-on collision between cars

Udupi: Family carries dead body on shoulders through knee-deep water

SpiceJet’s Delhi-Jabalpur flight returns after crew notices smoke in cabin mid-air

MS Dhoni gets treatment for knee pain in Ranchi village, doctor sits under a tree

Bengaluru: Woman from Brahmavar ends life after killing her daughter

Related Articles More

Novel antibody test detects Covid without blood sample

Monkeypox symptoms in UK patients differ from previous outbreaks: Lancet study

Cases of Breast Cancer are on the rise in India, says oncologists at Apollo Cancer Centres

COVID-19 vaccine protects people of all body weights: Lancet study

Outbreak of anthrax reported in Kerala’s Athirappilly forest region


India’s first unmanned combat aircraft flight successful

How to earn God’s grace?

NEW BULLETIN 01-07-2022

Heavy Rain Mallar Urdu school Damage

Heavy rain at kaup area

Latest Additions

Udaipur killing: Cong alleges one of main accused ‘BJP member’

Retired Karnataka SP gets 4 years in jail in disproportionate assets case

Capt Amarinder Singh to merge party with BJP, claims saffron party leader

Maha: Amravati chemist stabbed to death for alleged social media post supporting Nupur Sharma; five held

Five of a family found dead in Kerala

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.