SII Seeks Permission for Phase-3 Trial of Covovax as Booster Dose in Children Aged 2 to 18 Years

The Controller General of Drugs of India (DCGI) granted permission in March to conduct a phase 3 clinical trial of Covovax as a booster dose in adults.  (AFP)

The Controller General of Drugs of India (DCGI) granted permission in March to conduct a phase 3 clinical trial of Covovax as a booster dose in adults. (AFP)

India has started administering precautionary doses of Covid-19 vaccines to all over the age of 18 in private vaccination centers from April 10.

  • PTI New Delhi
  • Last updated:May 22, 2022 at 18:51 IST
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The Serum Institute of India (SII) has requested permission from the country’s drug regulator to conduct a Phase 3 trial to evaluate the safety and immunogenicity of its COVID-19 Covovax vaccine as a booster dose in children aged two to 18 years, official sources said. Sunday. The Controller General of Drugs of India (DCGI) granted permission in March to conduct a phase 3 clinical trial of Covovax as a booster dose in adults.

In an application, SII’s Director of Government and Regulatory Affairs Prakash Kumar Singh sought permission to conduct a Phase 3, randomized, controlled study in children aged two to 18 years in India who had already received their initial COVID-19 vaccination with Covovax since At least six months. The study will evaluate the immunogenicity and safety of the vaccine as a booster dose compared to a placebo.

Singh learned he had reported that it was becoming clear that protection against COVID-19 was waning after a two-dose schedule of vaccines and that more than 100 countries had started giving boosters. A total of 408 eligible children aged 2 to 18 years who had completed the baseline two-dose schedule of Covovax at least six months prior would be enrolled in the study.

Hyderabad-based Bharat Biotech recently sought permission from the drug regulator in India to conduct a phase 2/3 study of the Covid Covaxin vaccine as a booster dose among those aged 2 to 18 years. Covovax was approved for restricted emergency use in adults on December 28 of last year and in the age group 12 to 17, subject to certain conditions, on March 9.

India has started administering precautionary doses of vaccines to healthcare workers, frontline workers and those aged 60 and above with comorbidities from January 10 this year. The comorbidity requirement for people over 60 years of age has been abolished.

India has started administering precautionary doses of COVID-19 vaccines to all people over the age of 18 in private vaccination centers from April 10. Currently, all persons over 18 years of age who have completed nine months after administration of the second dose are eligible for the reserve dose.

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