FDA reviewing EUA amendments for 3 COVID-19 vaccines for minors

The Food and Drug Administration (FDA) said Monday that it is reviewing the emergency use authorization (EUA) amendments of three COVID-19 vaccines, including two Chinese-made shots, for the use of children and adolescents 18 years old and younger.

During a televised briefing, FDA officer-in-charge Director Oscar Gutierrez, Jr.,  revealed that the agency is reviewing the applications for EUA amendment of the following vaccines:

• Covaxin - applied for use for two to 18 years old
• Sinovac - applied for use for three to 17 years old as well as 12 to 17 years old
• Sinopharm - applied for use for three to 17 years old

Currently, Gutierrez said, the government approved the application for EUA amendment of the Moderna and Pfizer-BioNTech vaccines for inoculation of children 12 years old and above.

He added that the Pfizer-BioNTech vaccine is also authorized for kids aged 5 to 11 years old.

If the three vaccines are approved, the FDA official said, families will have five vaccines to choose from for their younger kids.

"Kung papasa itong tatlo sa ating clinical evaluation at sa standard ng FDA, magkakaroon po tayo ng limang bakuna sa immediate future po," he said.

Home COVID-19 antigen test kits

The FDA has also accepted nine more applications for self-administered antigen COVID-19 test kits.

From an initial two applications, FDA received five more on January 13 then another four applications on January 14. 

The applications were sent to the Research Institute for Tropical Medicine in Muntinlupa for performance validation.

"Itong labing isa dumaan na po sa FDA, at finorward sa RITM for performance validation," Gutierrez said.

The demand for the self-administered antigen COVID-19 test kit increased following the spike in the COVID-19 positivity rate, resulting in laboratories getting swamped with specimens  of individuals who subjected themselves to an RT-PCR test due to COVID-19 symptoms or exposure to a COVID-19 case. — BM, GMA News