The Food and Drug Administration (FDA) of the USA finally approved COVID-19 vaccines for children under 5 years of age on Friday.
According to international media reports the FDA authorized Pfizer’s three-dose vaccine for children 6 months to 4-years-old, and Moderna’s two-dose vaccine for children 6 months to 5-years-old.
This will now pave the way for Bhutan to also procure these vaccines from these two US companies and vaccinate its remaining unvaccinated population below 5 years of age.
This development will come as a huge relief to parents worried about their unvaccinated children under the age of five.
CNBC said that there is still one more step left before vaccinations of children under age 5 can begin. The Centers for Disease Control and Prevention’s committee will meet on Saturday to vote on guidelines for pharmacies and doctors’ offices. CDC Director Dr. Rochelle Walensky then has to sign off on those guidelines before kids can start receiving the shots.
The White House expects vaccinations to begin as soon as Tuesday as vaccines had already been produced and transported.
The CNBC report quotes Dr. Arnold Monto, acting chair of the FDA committee, saying it took longer for the agency to authorize the shots for infants through preschoolers than for other ages because they are a vulnerable group that requires special care to make sure the shots were safe and effective.
Pfizer’s vaccine is administered in three doses for children 6 months to 4 years old. The shots are dosed at 3 micrograms; one-tenth the level of what adults receive. Three shots were about 75% effective at preventing infection from omicron in 6-month- to 2-year-olds and 82% effective in 2- to 4-year-olds.
However, it is crucial that parents who opt for Pfizer make sure their kids get the third shot to have protection against the virus. Two doses were only about 14% effective at preventing infection for kids under age 2, and 33% effective for those ages 2 to 4.
Moderna’s vaccine is administered in two doses for children 6 months to 5 years old. The shots are dosed at 25 micrograms, one-fourth the level that adults receive.
Moderna’s vaccine was about 51% effective at preventing infection from omicron for kids 6 months to 2 years old, and about 37% effective for kids ages 2 to 5 years old. However, the company expects the vaccine to provide strong protection against severe illness because the kids had higher antibody levels than adults who received two doses.
The most common side effects from the vaccines were pain at the injection site, irritability and crying, loss of appetite and sleepiness, according to the FDA. Very few children who received either shot developed a fever higher than 102 degrees Fahrenheit, and there were no cases of myocarditis, a type of heart inflammation, in Pfizer’s or Moderna’s trials.
As per the National Statistics Bureau (NSB) projection, there are 58,531 children under five years who are the only unvaccinated group in Bhutan.
Officiating Director of the Department of Public Health (DPH) under Ministry of Health (MoH), Rixin Jamtsho had said the ministry is in contact with Pfizer company from the initial phase of COVID-19 procurement. MoH has paid advance money to Pfizer company for the purchase of pediatric Pfizer doses. MoH will start procuring the vaccines as soon as the regulatory authorities approve vaccination for children under five years.
With the FDA in USA granting approval to the vaccines the health ministry in Bhutan will seek recommendations from the National Immunization Technical Advisory Group (NITAG). If NITAG recommends the use of COVID-19 vaccines for children under five years, MoH will seek EUA approval from the regulatory authorities (DRA), in Bhutan.
If all population above 6 months could be vaccinated, the health ministry is expected to achieve about 95 percent vaccination with the primary series of COVID-19 vaccination.
The vaccination of children under 5 in Bhutan will also encourage the government to open up restrictions even faster.