DOH submits additional evidence for FDA's approval of 4th Covid-19 shot, booster for minors

The Department of Health (DOH) has provided additional evidence to the Food and Drug Administration (FDA) for the amendment of the emergency use authorization (EUA) to allow the administration of the fourth dose of Covid-19 vaccine to senior citizens and immunocompromised individuals and to include booster shots for minors aged 12 to 17.

A senior citizen getting his booster shot in Muntinlupa (Muntinlupa PIO)

This was disclosed by DOH Spokesperson Maria Rosario S. Vergeire Tuesday, April 12, during a virtual media briefing.

The FDA, she said, has requested more evidence before it can decide whether to allow the EUA amendment or not.

Vergeire said the DOH submitted the EUA amendment to the FDA on March 14.

“They responded and requested for additional evidence for amended EUA para sa (for the) fourth dose of immunocompromised and senior citizens, and booster dose for 12 to 17 years old,” she said.

The DOH has already provided additional evidence asked by the FDA and is now waiting for its feedback, she said.

“We are already able to submit additional evidence from our Evidence Generation Team at ito na ay pinag-aaralan na ng FDA (and FDA is now studying it),” Vergeire said.

“Hintayin lang natin ang FDA na maglabas ng kanilang pagsusuri or resulta (Let’s just wait for the FDA to release its findings) if we were able to amend the EUA for this.”

Senior citizens and people with comorbidities face a significant risk of developing severe illness should they get infected with Covid-19, per experts.

In March, the expert panel of the National Task Force (NTF) against Covid-19 has recommended administering a fourth dose of the vaccine or second booster shot to senior citizens and immunocompromised individuals.