Bharat Biotech has submitted Phase 2/3 clinical trials data of Covaxin for children to the Drugs Controller General of India (DCGI), CNBC-TV18 has reported.
The DCGI will request its subject expert committee (SEC) to consider the request for Emergency Use Authorisation (EUA) for the vaccine against COVID-19, sources told the news channel.
Two doses of Covaxin will be administered to children with a gap of 28 days, the report said. For adults, the government has set a gap 4-6 weeks between the two shots.
In the trial, Covaxin was administered to 525 children in the 2-18 age group.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
ZyCoV-D, has been approved for children aged 12 and above as well as adults. However, the rollout has not yet begun.
The Centre is hopeful of a positive outcome from the final round of discussions with Zydus Cadila about its vaccine, Karnataka Health Minister K Sudhakar said on October 2.
Sudhakar made the statement after a meeting with Union health minister Mansukh Mandaviya.
"I had a lengthy discussion with the Union minister about children vaccination. He (Mandaviya) informed that the government is having a final round of discussion with Zydus with regard to its COVID-19 vaccine for children. He said he was hoping for a positive outcome soon," he was quoted as saying by PTI.Since the start of the inoculation drive, 66.7 lakh adults have taken at least one dose a COVID-19 vaccine, and 25.4 crore are fully vaccinated, according to the health ministry's latest update.