Bharat Biotech Submits Data On Covaxine Given To Children
Bharat Biotech submits data on covaxine given to children.
Bharat Biotech has submitted the data of Phase II and III clinical trials of the vaccine to children below 18 years of age with the Central Drugs Standard Control Organization (CDSCO).
Company sources said that emergency use of this vaccine These data has been submitted for approval.
Sources said that the company has conducted Phase II and III clinical trials of Covaxine on children in the age group of two to 18 years.
Company sources said on Wednesday, “Covaxine clinical trial data for the age group of 18 years has been submitted to CDSCO.”
“This is possible because of the safety of the manufacturing platform and the empirical evidence from Phase 1, 2, and 3 clinical trials in adults.”
Let us tell you that the World Health Organization will take a final decision next week about granting Emergency Use Listing (EOL) status for Bharat Biotech’s anti-corona vaccine.
“WHO and an independent group of experts will meet next week to conduct a risk/assessment and make a final decision on whether to approve emergency use listings for the vaccine,” the tweet said.
The WHO’s Strategic Vaccination Experts Consultative Group (SAGE) met on Tuesday to give its recommendations on the EUL and discuss other topics.
The WHO said in its tweet, ‘Bharat Biotech, the manufacturer of the vaccine, is continuously submitting the data to the WHO and on 27 September it also submitted additional information on the request of the WHO.
Bharat Biotech submits data: WHO experts are currently reviewing this information and if it addresses all concerns, a final WHO assessment will be done next week.
Pharmaceutical company Cadila Healthcare said on Tuesday that it has received approval from the Indian drug regulator to conduct Phase III trials of its two-dose anti-coronavirus vaccine Zycov-D.
The company has also developed a three-dose Zycov-D, which has already received approval for emergency use from the Drug Controller General of India (DCGI). It will be applied to children above 12 years of age and adults.
