The Ministry of Health is preparing a vaccine for children under 5

Nima Wangdi

With the Food and Drug Administration (FDA) having authorized Covid-19 vaccines for children aged six months to four years, the Ministry of Health is already working to make them available in Bhutan.

Health Minister Dechen Wangmo said the ministry had already made advance payment for the vaccines. “At this time, we are cautiously monitoring vaccine updates globally and our own outbreak.”

The Ministry of Health has also concluded an agreement with the Pfizer company for the purchase of 84,000 doses intended for children in this age group.

The FDA cleared Emergency Use Authorization (EUA) for Moderna and Pfizer-BioNTech Covid-19 vaccines for children up to six months of age on June 17 this year. With this, the only unvaccinated part of the population of Bhutan, children aged six months to four years will be vaccinated.

According to the FDA, for the Moderna vaccine, they amended the EUA to include use of the vaccine in individuals six months to 17 years old. “The vaccine had been authorized for use in adults 18 years of age and older.”

For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include use of the vaccine in people six months to four years old. The vaccine had been cleared for use in people five years of age and older according to the FDA.

The FDA said its evaluation and analysis of the safety, efficacy, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs. “The agency has determined that the known and potential benefits of the Moderna and Pfizer-BioNTech vaccines outweigh the known and potential risks in pediatric populations licensed for use for each vaccine.”

Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s Independent Advisory Committee on Vaccines and Related Biologicals was consulted and voted in favor of the authorizations.

The FDA said many parents, caregivers and clinicians have been waiting for a vaccine for young children and that this action will help protect those up to six months old. “As we have seen with older age groups, we expect vaccines for young children to provide protection against the most severe consequences of Covid-19, such as hospitalization and death. .”

Maria J. Book