The vaccine of Bharat Biotech, which makes the anti-Covid-19 vaccine Vaccine, can be given to children in the age group of 2 to 18 years in the US. For this, Bharat Biotech’s subsidiary Ocugen Inc. has sought permission from the Canadian and US authorities. If the US and Canada allow this, then the corona vaccine made by Bharat Biotech in India (COVAXIN) will start being used in these two countries as well.
OcuGen, a partner of Bharat Biotech in the US and Canada, said on Friday that it has applied to the US Food and Drug Administration (FDA) for the use of the vaccine for children for the anti-Covid-19 vaccine. OcuGen has told both the countries that its application is based on the results of Phase II-III ‘Clinical Trial’ in India on 526 children and adolescents aged two to 18 years by Bharat Biotech.
To know the effectiveness of the vaccine, the results of the third phase conducted on about 25,800 adults in India have also been mentioned. Shankar Musunuri, Chief Executive Officer, Co-Founder and Chairman of the Board, said, “Application for Emergency Use of Vaccines in the US for Pediatric Use is an important step in providing the vaccine and helping to combat the COVID-19 pandemic. An important step in that direction.”
He said that some studies have come to the view that people want more choices in the selection of vaccines for themselves and especially for their children. With the availability of new types of vaccines, people will be able to make better decisions for their children after consulting doctors. Recently the World Health Organization (WHO) approved the emergency use of Covaxin.
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However, it may happen that the data provided by Ocugen, in which the test is carried out outside the US, will not be sufficient for the FDA to accept the request. That is, it is possible that the proposal of a subsidiary of Bharat Biotech may be rejected.
This trial was conducted in India by Bharat Biotech from May to July this year. Covaxin was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years and all participants were given two doses of the vaccine spaced 28 days apart. After this test conducted on 526 children, no serious adverse event was seen in any child, nor did anyone have to be hospitalized.
Currently, the Pfizer vaccine is the only vaccine approved in the US for children under the age of 18. Covaxin, developed in India by Bharat Biotech, received emergency use approval from the World Health Organization (WHO) on Wednesday and has already been approved for use in 17 countries.
It is one of the four vaccines being used in India in the nationwide immunization program in India. The other three vaccines are Covishield, Sputnik V and a vaccine made by Zydus Cadila.
