New Delhi [India], March 7 (ANI): Bharat Biotech’s COVID-19 vaccine Covaxin has been given clearance for clinical trials in adults by the US Food and Drug Administration (FDA).
In a statement on Monday, Bharat Biotech and its US partner Ocugen expressed their commitment towards bringing Covaxin to the US and Canada for all age groups.
The statement informed that Covaxin has been cleared by the US FDA for conducting clinical trials in adults.
“Recently, Ocguen’s phase 2/3 investigational drugs application for Covaxin was cleared by the US Food and Drug Administration (FDA) for conducting clinical trials in adults,” read the statement.
It further said that Ocugen intends to continue working with FDA to evaluate regulatory pathway for the pediatric use of Covaxin. Notably, Hyderabad-based Bharat Biotech had earlier informed that Covaxin will be evaluated as a vaccine candidate for the disease in the United States.
“Ocugen, Inc (NASDAQ: OCGN) announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as Covaxin outside the United States. Ocugen, Inc is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 in USA and Canada,” read Bharat Biotech’s statement.
COVAXIN approved for emergency use in 13 countries: MoS for Health Bharati Pravin Pawar
New Delhi [India], February 8 (ANI): Covaxin has been granted approval for emergency use in 13 countries as of January 31, 2022, according to the WHO, said Minister of State (MoS) for Health Bharati Pravin Pawar in Lok Sabha on February 4. Giving the details about Covaxin, the MoS for Health said, “Covaxin has been granted Emergency Use Listing (EUL) by National Regulator Drug Controller General of India (DCG(I)) in the age-group from 12 to 18 years on 24th December 2021.”
In her written reply, she mentioned that the COVID-19 Working Group of National Technical Advisory Group on Immunisation (NTAGI) recommended Covid-19 vaccination in adolescents aged 15 years to less than 18 years. “On the recommendation of COVID-19 Working Group and Standing Technical Subcommittee of National Technical Advisory Group on Immunization (NTAGI), Government of India has started vaccination of adolescents aged 15 years to less than 18 years from 3rd January 2022,” she informed the Lok Sabha.
She said that the grant of approval to a vaccine by any country is a technical and scientific process for which data is to be submitted to the regulator by the vaccine manufacturer as per the prescribed rules.
Regarding supplies, she said that no specific information has been brought to notice by foreign companies that they are facing difficulties in the supply of COVAXIN.
“During the second surge of Covid cases in April, May 2021 in the country, the requirements of National Covid-19 Vaccination Programme were prioritized. This may have impacted foreign commercial contracts entered into by domestic vaccine manufacturers. As informed by the Ministry of External Affairs, there is no financial loss involved since during the second surge of COVID pandemic in the country, domestic vaccine production was procured and utilized in the National Covid-19 Vaccination Programme,” she added. (ANI)
