FDA says Pfizer likely to apply for EUA extension of COVID-19 jabs for Filipinos aged 12 to 15

Picture of vials of the Pfizer-BioNTech vaccine against COVID-19 taken as elderly people are being inoculated amid the novel coronavirus pandemic, at the Belisario Porras school San Francisco neighborhood in Panama City on March 4, 2021. (Photo by Luis ACOSTA / AFP)

MANILA, Philippines — US drugmaker Pfizer is expected to apply for an expansion of its emergency use authorization (EUA) in the Philippines for its COVID-19 vaccine so that the product can be used for adolescents aged 12 to 15, the Food and Drug Administration (FDA) said Tuesday.

FDA Director General Eric Domingo expressed optimism that the American firm will also apply for the expansion of its EUA in the country after the New York Times reported that the US FDA is preparing to authorize Pfizer’s vaccine for those aged between 12 and 15 years by early next week.

“We are expecting na magpapa-approve na rin sila for 12 to 15 dito sa atin, kaya lang hindi pa kasi dumarating ‘yung pinakaunang order natin ng Pfizer,” Domingo said in an interview with DZBB.

(We are expecting that they will also ask for approval here to include 12 to 15 years old in their EUA. However, our first order of Pfizer vaccine has yet to arrive.)

The Philippine FDA granted an EUA for the COVID-19 vaccine of Pfizer in January. In granting the EUA, Domingo said that the vaccine should be “used only to prevent COVID-19 in individuals ages 16 and older.”

Domingo, however, noted that vaccine manufacturers normally expand their studies so that more people will be able to benefit from their products.

According to reports, the US FDA is anticipated to approve the expansion of Pfizer’s EUA after the company said in March that its vaccine was found to be safe and effective and produced robust antibody responses among those aged 12 to 15 in a clinical trial.

Vaccine czar Carlito Galvez Jr. said in April that some 2.3 million doses of Pfizer’s COVID-19 vaccine from the COVAX Facility will arrive in the Philippines “not later than June.”

EDV