With the food and drug administration (FDA) having authorised the Covid-19 vaccines for children aged six months to four years, the health ministry is already working toward making them available in Bhutan.
Health Minister Dechen Wangmo said that the ministry has already made an advance payment for the vaccines. “For now, we are cautiously monitoring vaccine updates globally and our own epidemic.”
The health ministry also has an agreement with Pfizer company to procure 84,000 doses for children in this age group.
FDA authorised emergency use authorisation (EUA) of the Moderna and the Pfizer-BioNTech Covid-19 Vaccines for children down to six months of age on June 17, this year. With this, Bhutan’s only unvaccinated section of the population, children aged six months to four years will get vaccinated.
According to FDA, for the Moderna vaccine, they amended the EUA to include the use of the vaccine in individuals six months through 17 years of age. “The vaccine had been authorised for use in adults 18 years of age and older.”
For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include the use of the vaccine in individuals six months through four years of age. The vaccine had been authorised for use in individuals five years of age and older according to FDA.
FDA stated that their evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs. “The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech vaccines outweigh the known and potential risks in the pediatric populations authorised for use for each vaccine.”
Prior to making the decision to authorise these vaccines for the respective pediatric populations, the FDA’s independent vaccines and related biological products advisory committee was consulted and voted in support of the authorisations.
FDA stated that many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to six months of age. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of Covid-19, such as hospitalisation and death.”