Covaxin Recommendation For Trial Phase of 2–18 Years Age Group:
Summary: Bharat Biotech’s COVID-19 vaccine was recommended on Tuesday by a panel of experts from phase 2 and phase 3 clinical trials for those between the ages of two and 18 years, official sources said. The national director of Drugs Controller General of India (DCGI) has accepted the recommendations of the Subject Specialists Committee (SEC) and offered Bharat Biotech Ltd the opportunity to conduct a phase II / III clinical trial of the COVID-19 Covaxin vaccine in a 2- to 2-year period 18. Bharat Biotech based in Hyderabad had proposed a Phase II / III study of Covaxin in the two- to 18-year group. The trial will be held on 525 healthy volunteers. In the trial, the vaccine will be administered intramuscularly in two doses per day 0 and 28 days. As an immediate regulatory response, this recommendation was discussed with the SEC on May 11. The committee after careful consideration recommended approval to carry out the proposed Phase II / III clinical trial in certain cases.
Introduction:
Earlier the proposal was discussed at a SEC meeting on February 24 and the company was asked to submit a follow-up clinical trial rule. Covaxin, traditionally developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is used in adults in India’s ongoing COVID 19 vaccine program. With the exception of Covaxin, the Serum Institute of India’s Covishield vaccine is used to vaccinate people in India. The vaccine registered with the Russian Direct Investment Fund (RDIF), Russia’s economic fund, has also received India’s regulatory approval to manufacture and sell its Sputnik V vaccine in India. Dr. Reddy’s will oversee its vaccination operations in India. The COVID-19 Central Committee of the Central Drugs Standard Control Organization (CDSCO) Committee on Tuesday considered Bharat Biotech’s application based in Hyderabad, seeking permission to conduct phase II / III clinical trials to monitor safety, rehabilitation and physical impairment. Covaxin jabs in children 2 to 18 years of age.
Picture Courtesy: Scrabbl
Covaxin Recommendation for the Experimental Phase 2–18 Age Group:
India has granted Bharat Biotech permission to test Covaxin in children, which marks an important milestone in the development of the Covid-19 vaccine. One of the two Covid-19 vaccines used in India’s largest trial against the virus, Covaxin was developed by Hyderabad’s leading vaccine manufacturer Bharat Biotech in partnership with the government of the Indian Council of Medical Research (ICMR). It is an ‘ineffective’ vaccine that uses the deadly SARS-COV-2 virus to help improve the human immune response to the virus, which has so far infected more than 2.3 crore people in India and killed about 2.6 lakh patients, according to official statistics. To date, Covaxin has been approved for use in those over the age of 18, while its safety and immune response are tested for those aged 12 to 65 years. The trial will be held at 525 healthy volunteers in various parts of the country. These sites are expected to include AIIMS, Delhi and AIIMS, Patna and the Meditrina Institute of Medical Sciences in Nagpur.
Conclusion:
The trial is expected to study factors such as vaccine safety in this age group, types of adverse reactions caused and the ability of the drug to stimulate immune response. The vaccine will be given intramuscularly in two doses except for 28 days.
