Additional evidence on boosters submitted to FDA —DOH

The Department of Health (DOH) has submitted additional evidence on the effectiveness of booster shots and additional doses of COVID-19 vaccines to the Food and Drug Administration (FDA), an official said Friday.

“Kami po ay nagkaroon ng pagpupulong with the all experts early part of the week… nakapagkalap kami ng additional evidence regarding boosters and third doses at ito po ay lahat isinumite na natin sa FDA,” Health Undersecretary Maria Rosario Vergeire said in a media briefing.

(We had a meeting with all experts earlier this week… we gathered additional evidence regarding boosters and third doses and we have submitted these to the FDA.)

Vergeire previously said the DOH has passed its letter of intent for the application of the emergency use authorization to the FDA and that it is working on completing the required documents.

Vergeire on Thursday said the FDA is now reviewing the EUA of COVID-19 vaccines.

Vergeire, however, said the process will not be easy due to lack of evidence. She said the FDA is only seeking to ensure the safety and effectiveness of the boosters and additional doses.

“So dito po ang Food and Drug Administration natin gusto lang makasiguro na alam po natin na it’s really going to be safe and ito po ay magiging epektibo para malabanan pa natin patuloy ang COVID-19,” she said.

(The FDA only wants to ensure that it is going to be safe and effective.)

Vergeire said the EUA of the vaccines must be amended as it specifically states the number of doses that must be administered on an individual to complete the vaccination. —KBK, GMA News