Children’s COVID-19 Vaccine: Covaxin Receives Emergency Use Approval for Children Over 2 Years Old

The Subject Expert Committee (SEC) on Covid-19 has given emergency use approval for Covaxin, a COVID-19 vaccine developed by Bharat Biotech, for children ages 2-18. This is one of the first global approvals for COVID-19 vaccines for the 2-18 age group.

Covaxin is the second COVID-19 vaccine approved for emergency use in children in India. Earlier in August 2021, India granted emergency use approval to ZyCov-D, the COVID-19 vaccine developed by pharmaceutical company Zydus Cadila, for children aged 12 to 18 years. The vaccine is the first DNA vaccine approved in the world.

Other candidate vaccines being considered for children include Covovax and Corbevex. Both vaccines have been given the green light to conduct interim studies in children 7-14 years old.

Bharat Biotech announced the completion of Phase 2 and Phase 3 studies of Covaxin in children under 18 years of age in September 2021. Bharat Biotech submitted the study data to the DCGI (Drugs and Comptroller General of India) for verification and subsequent approval for emergency use permission for the jab early this month.

The Central Drugs Standards Control Organization (CDSCO) and the SEC on COVID-19 have reviewed the submitted data, which includes recommendations for marketing authorization of this vaccine for the age group 2 – 18 years for limited use in emergency situations.

The vaccine is given in two doses, with an interval of 20 days between the first and second dose.

The developer of Covaxin will continue the study according to the approved clinical trial protocol and provide updated prescribing information/package.

The company is now awaiting further regulatory approvals from the CDSCO before marketing the product to children.

In addition, according to the requirements of New Drugs & Clinical Trials Rules, 2019; The company must submit safety data, including AESI and AEFI data, with the necessary analysis, every 15 days for the first two months and every month thereafter.

Frequently Asked Questions

  • Do children need the COVID-19 vaccine?

Yes, the vaccine helps prevent or reduce the spread of COVID-19. While children are so far unlikely to develop serious complications or serious illness due to COVID-19, they may spread the infection to adults who are more prone to develop serious complications or serious illness due to COVID-19 .

The COVID-19 vaccine can protect the child and help reduce the spread of COVID-19 infection.

  • When can children receive the COVID-19 vaccine?

The SEC (Subject Expert Committee) recently approved Covaxin, a COVID-19 vaccine developed by Bharat Biotech for emergency use in children aged 2-18. While the SEC recommended approval for the vaccine’s use in children, which came as a great relief to parents and educational institutions, there is no official confirmation of the likely date yet.

  • What other vaccines would be available for children?

While Covaxin is the first vaccine officially approved for use in children between the ages of 2 and 18, other vaccines are also being planned to vaccinate children in India. Previously, ZyCov-D, a COVID-19 vaccine developed by Zydus Cadila, was considered for use in children ages 12 to 18. While trials are still underway, it may take some time for the vaccine to reach the market.

Other candidate vaccines being considered for children include Covovax and Corbevex. Both vaccines have been given the green light to conduct interim studies in children 7-14 years old.

  • What does Emergency Use Authorization (EUA) mean for children?

Emergency Use Authorization (EUA) refers to a mechanism whereby authorities allow the use of certain drugs and vaccines in a life-threatening emergency, such as COVID, after reviewing the clinical studies and laboratory data. Covaxin is currently authorized for emergency use in India – not full access. Although Covaxin is still undergoing important final phase research, the necessary EUA was awarded based on risk-benefit analysis.

  • Is it safe to send my child to school for the vaccination?

Fortunately, the risk of moderate to severe COVID-19 infection and mortality in children is very low compared to adults. You can send children to school, provided that a number of precautions are strictly observed. Wearing a face mask throughout the school community, including children (whether vaccinated or not) is the first step in preventing the spread of infection.

These steps are even better when combined with physical distancing, hand washing, fever screening and improving ventilation (such as turning off air conditioning, leaving doors and windows open) in the school.

In addition, all teachers, including other school staff, must be vaccinated and ensure proper mask compliance in classrooms. However, children under the age of two may be an exception.

To successfully implement all of these precautions, school staff must exhibit COVID-appropriate behavior at all times and closely monitor children.

  • Can a child who has recovered from a COVID-19 infection receive a COVID-19 vaccination?

Yes. The child must receive a COVID-19 vaccination if it has been more than three months since they were infected. This is because a COVID-19 infection does not provide permanent immunity against the disease. There are chances of recurrence of this infection. Many cases have been reported of children getting COVID-19 twice.

  • Will children be affected by the third wave?

It is unlikely that the third wave will only affect children. It can affect both adults and children. The chance of children becoming infected with COVID-19 is comparable to that of adults. In addition, there are no reports of a higher severity of this disease in children.

While there is no reason to panic, there is still cause for concern. It is better to take all precautions because while most of the adults have been vaccinated, vaccines for children have not yet started in India.

Leave a Comment