COVID-19 vaccines

DOH seeks FDA approval for COVID-19 booster shots for minors 12 to 17

Bonz Magsambol

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DOH seeks FDA approval for COVID-19 booster shots for minors 12 to 17

BOOSTER SHOTS. Cebu residents receive vaccine booster jabs at a COVID-19 vaccination facility in Cebu City.

Jacqueline Hernandez/Rappler

'Atin lang pong hinihintay ang FDA na maglabas ng amended EUA,' says Health Undersecretary Maria Rosario Vergeire
DOH seeks FDA approval for COVID-19 booster shots for minors 12 to 17

MANILA, Philippines – The Department of Health (DOH) said on Friday, April 9, that it has sought a request from the Food and Drug Administration (FDA) for the amendment of the emergency use authorization (EUA) of COVID-19 vaccines to include booster shots for minors aged 12 to 17.

“‘Yan pong fourth dose at booster shots for kids, tayo po ay nag sumite na ng request for the EUAs to be amendment [at] for booster shots for 12 to 17. Atin lang pong hinahantay ang FDA na maglabas ng amended EUA. Kapag lumabas po ito ay isusumite po natin sa Health Technology Assessment Council  para sa kanilang pagsusuri pa,” Health Undersecretary Maria Rosario Vergeire said in a press briefing.

(For the fourth dose and booster shots for kids, we have already requested for the EUAs to be amended for [and] booster shots for 12 to 17 years olds. We are now waiting for the FDA to release the amended EUA. Once this is out, we are going to submit this to the Health Technology Assessment Council for their assessment.)

She added that once the DOH gets approval, they will issue out guidelines.

The health spokesperson also said that the DOH was still waiting for the approval of the amended EUA of COVID-19 vaccines to include a fourth dose for the elderly and immunocompromised individuals. (READ: DOH seeks FDA approval for 4th dose of vaccines for elderly, immunocompromised)

Currently, EUA of the COVID-19 vaccines in the country is only for the administration of primary doses and booster doses for the general population, and third shots for the elderly and immunocompromised individuals who failed to gain sufficient immunity despite their primary vaccination.

An EUA clears the way for vaccines and medicines to be used by the public even while these are still in the development phase. This, however, is not equivalent to a certificate of product registration or authorization to market the product.

If the DOH gets FDA approval, the Philippines will join a number of countries that started administering booster shots to minors aged 12 to 17. This will also be a welcome development as the threat of another variant Omicron XE looms.

As of Thursday, April 7, over 66.5 million of the Philippines’ 110-million population have been fully vaccinated against COVID-19. – Rappler.com

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Bonz Magsambol

Bonz Magsambol covers the Philippine Senate for Rappler.