US FDA Allows Pfizer-BioNTech COVID Vaccine For Children 5-11 Years Old, Dose Of 10 Micrograms

JAKARTA - The US Food and Drug Administration (FDA) on Friday, October 29, authorized the COVID-19 vaccine for children aged 5-11 years.

The Pfizer-BioNTech vaccine is the first COVID-19 vaccine to be FDA-approved for use in children in the US. However, the injections are not immediately available for this age group.

The US Centers for Disease Control and Prevention (CDC), reported by Reuters via Antara said, are still making guidelines on how the injection should be given.

Pfizer said it would begin shipping ampoules of the pediatric vaccine to pharmacies, pediatricians' offices and other facilities this Saturday.

The FDA decision is expected to make a COVID-19 vaccine available to 28 million US children, most of whom have returned to school for face-to-face learning.

The decision came after an FDA advisory panel voted to recommend the clearance on Tuesday. Only a handful of countries, such as China, Cuba and the United Arab Emirates, have so far approved COVID-19 vaccines for children in that age group and younger.

The FDA allows a Pfizer vaccine dose of 10 micrograms for children, which is lower than the standard 30 microgram dose for ages 12 and over.

The FDA's advisory panel said lower doses could help reduce some of the rare side effects after paying close attention to rare heart inflammation or myocarditis, which has been linked to the Moderna and Pfizer vaccines, especially in men.

The FDA on Friday said the potential and known benefits of the Pfizer vaccine in the 5-11 year age group outweigh the risks. For pediatric injections, the FDA allows a new version of the vaccine that uses a new buffer and can be refrigerated for up to 10 weeks.

Acting FDA commissioner Dr. Janet Woodcock said at a press conference that she hopes that when the public sees their children being vaccinated and they are protected and can participate in activities without any worries, more people will have their children vaccinated.

When people have more experience with vaccines, confidence in their safety will emerge, he said.

Pfizer and BioNTech claim their vaccine showed 90.7 percent efficacy in clinical trials of children aged 5-11 years.