Hyderabad: Close on the covid-19 covaxin vaccine heel developed by the original regulator of the drug for vaccine use in children aged 2-18 years.
Ocugen Submission for US Food & Medicine Administration (USFda) Looking for EUA NOD for Pediatric Covaxin on the US market Coming even when Bharat Biotech has submitted data from children’s trials to the controller of Indian General Medicines (DCGI) and looking for EUA nodded for the Indian market .
Submission of Pediatric EUA is based on the results of the Bridging Immuno clinical trials carried out by Bharat Biotech in 526 children aged 2-18 years and showed comparable antibody response as seen in the clinical test of large adult 3 phase conducted in India, said Ocugen in submission Regulations on Friday.
Covaxin was evaluated in three age groups – 2-6 years, 6-12 years and 12-18 years – with all participants receiving two doses of the inactive SARS-COV-2 virus vaccine.
Providing details of the results of children’s trials conducted in India from May 2021 to 2021 July 2021, Ocugen said more than 90% of seroconversion levels were observed for antibody titers against S1 protein, RBD, N and illegal type antibodies, which showed similar protection on Children because they are shown in adults who are older than 18 years.
Ocugen also shows that “there are no serious hospital effects or hospitalization in a phase 2/3 pediatric study of Kovaxin, including no special interest events such as Guillain-Barre syndrome, anaphylaxis reactions, myocarditis, pericarditis, and thrombotic induced by vaccines, and thrombocytopenia vaccines “.
These side effects are also not observed in data on supervision collected in India after administration of more than 59 million doses of covaxin in adults, he added.
Ocugen says all other bad events are light or medium and are generally completed within 24 hours.
Shows that Covaxin uses the same Vero cell making platform as other traditional childhood vaccines, including inactive polio vaccines, Ocugen chairman, CEO and Co-Founder Dr.
Shankar Musunuri said: “Our research shows that people are looking for more choices when choosing a vaccine , Specifically for their children …
if permitted, we hope to offer other vaccine options to protect children as young as 2 years.
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