Two important developments took place on December 25th, 2021. These are:
A. The Drugs Controller General of India (DCGI) granted emergency use authorisation (EUA) to Covaxin for children above 12 years.
B. In an address to the nation on Saturday night, the Prime Minister of India, Shri Narendra Modi, announced that children 15-18 years of age can get vaccinated from January 3rd, 2022.
Update: Young adults will be able to register on the government’s platform, CoWIN from January 1st, 2022, using their school identity cards.
How was Emergency Use Approval given to Covaxin?
Bharat Biotech, the company behind Covaxin, conducted clinical trials on children.
A clinical trial is conducted on patients who are willing to volunteer. The vaccine is administered to them and they are observed for any side effects or reactions to the medication. They are also observed for symptoms of severe Covid infection. (In the case of Covid vaccines, only symptoms are being checked, not presence of virus).
In October, the results of this clinical trial were submitted to the Subject Expert Committee on COVID-19 (SEC) of the Central Drugs Standard Control Organisation (CDSCO). On October 11th, this committee of experts recommended that Covaxin should be approved for Emergency Use Authorisation (EUA) for children 2-18 years of age.
This recommendation was sent to the Drugs Controller General of India (DCGI).
DCGI is the highest approval body in India. To introduce any new medicine (medicines are also called drugs) in India, the approval of DCGI is required.
After getting this report, DCGI asked Bharat Biotech for some more details and information. This information was shared with the DCGI.
On December 25th, DCGI approved emergency use of Covaxin for children above 12 years of age. This approval has the following conditions:
A. Submission of SmPC – Summary of Product Characteristics – This is a document that is approved. This is information that is read by doctors and healthcare professionals. It gives them details of the product.
B. Product Insert (PI) – This is the printout that you get when you buy a medicine, usually ones that come in a box, so that the PI can be inserted in the box. This has information that the person using the medicine must have before they decide to use the medicine.
C. Factsheet incorporating (including) clinical information.
D. Pharmacovigilance and risk management plan – A plan to ensure that adverse reactions to the vaccine are recorded and monitored, and a plan to manage the risks arising from the use of the vaccine.
Here is an excerpt of the order from DCGI:
“… Based on the recommendations of SEC experts and submission of additional safety data, this directorate has no objection at this stage for additional indication of Whole Virion inactivated corona virus vaccine for use in age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in emergency situation with the condition to submit SmPC, PI, Factsheet incorporating clinical information for said age group along with pharmacovigilance and risk management plan,”
The other vaccine that has got this approval from the DCGI is Cadila Pharma’s Zycov-D.
Updated on 5th January 2022: Students can register on the governments CoWin app using any photo identity card and book a slot online, just like adults.