Corbevax, Covaxin get drug regulator nod for use in children between 5 and 12

A health worker displays vials of COVID-19 vaccines Corbevax and Covaxin at a vaccination centre in New Delhi on March 21, 2022. | Photo Credit: SHIV KUMAR PUSHPAKAR

Amidst an uptick of fresh COVID-19 cases in the country, the Drugs Controller General of India (DCGI) on Tuesday approved the emergency use authorisation for two anti-coronavirus vaccines in children between 5 and 12 years, senior officials in the Health Ministry confirmed.

The move comes even as several State governments are now reimplementing COVID-19 protocols and Prime Minister Narendra Modi is scheduled to hold a meeting with Chief Ministers on April 27 on the emerging COVID-19 situation.

Biological E’s Corbevax has been approved for administration in children between the ages of 5 and 12 and Bharat Biotech’s Covaxin has been approved for restricted use in emergency situations in children aged 6-12.

Currently, Bharat Biotech’s inactivated whole virion vaccine is being administered in children aged 15-18, and Biological E’s protein sub-unit vaccine in children aged 12 -15 under a national COVID-19 immunisation programme.

The DCGI has also cleared ZyCoV-D’s two-dose formulation for children aged over 12. With this approval, this vaccine will now be administered on day 0 and day 28. Earlier, the vaccine was approved in a three dose regimen to be administered on day 0, day 28 and day 56.

Dr. Sharvil Patel, MD, Zydus Lifesciences said: “The approval of a two-dose regimen for ZyCoV-D is a welcome development. This will increase the compliance of the vaccine and reduce the overall time required for vaccination to improve immunity against the virus. It will also help in administering the vaccine in a larger population in a shorter time which is always desirable in the midst of a pandemic.”

SEC recommendations

Approval by the DCGI for Corbevax and Covaxin comes following recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO).

Last week, the SEC reviewed the application of both the companies seeking emergency use authorisation. Covaxin was granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 on December 24, 2021. India began inoculating children aged 12-14 on March 16.

“This latest move is aimed at covering the younger population and offering them vaccination protection against COVID,’’ said an official.

Countrywide vaccination drive

India rolled out its countrywide vaccination drive on January 16 last year, with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year. The next phase of vaccination commenced on March 1 last year for people over 60 years and those aged 45 and above with specific comorbid conditions.

 India launched vaccination of all people aged more than 45 from April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 to be inoculated against the viral disease from May 1 last year.

The next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18. India began administering the precaution doses of vaccines for healthcare and frontline workers and those aged 60 and above with comorbidities from January 10. Precaution doses of vaccines to all aged above 18 was allowed at private vaccination centres from April 10.

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Printable version | May 3, 2022 7:43:36 pm |