FDA: Pfizer, AstraZeneca, Sinovac, Sputnik apply for EUA for booster shot

Food and Drug Administration director general and DOH Usec. Eric Domingo. Screengrab from Department of Health (Philippines) Facebook Live

MANILA, Philippines — Four vaccine makers have so far sent applications to the Food and Drug Administration (FDA) for an emergency use approval for their third dose or booster shot, the agency said Wednesday.

In a taped briefing with President Rodrigo Duterte aired on Wednesday morning, FDA Director-General Eric Domingo said the drug firms for COVID-19 vaccines Pfizer, AstraZeneca, Sinovac, and Sputnik V have applied for “product variation” or amendment of their emergency use approval.

“Nag-request sila na ma-include ang third dose sa kanilang regimen or a booster dose,” he said.

(They have requested to include a third dose or booster dose in their regimen.)

“Pinadala nila ‘yung kanilang scientific data available at ito ‘yung inaaral ngayon ng ating mga expert,” he added.

(They have sent their scientific data available and our experts are studying them now.)

The Department of Health (DOH) earlier explained that a COVID-19 third dose and booster shot are different.

Citing the World Health Organization, the DOH said booster shots are provided due to waning immunity several months after the primary course of vaccination.

Meanwhile, third doses are given to people such as individuals with comorbidity and senior citizens who may have not mounted sufficient immunity against the disease.

The FDA is also studying mixing and matching different vaccine brands for the third dose or booster shot, Domingo said.

“Applications for booster shots are now under evaluation and our vaccine experts are reviewing submitted data,” Domingo said.

With this, he said that the “trend” seen for booster or third doses is that it will be not for the general population but only for selected people who would need it, particularly the elderly, immunocompromised, and healthcare workers.

Authorities are also waiting for the final recommendation of the World Health Organization (WHO) on booster shots, which are expected to be released within two weeks, Domingo said.

He added that the Department of Health (DOH) is already preparing the guidelines for the rollout of third doses.

However, while the country is waiting for the final recommendations on booster doses, Domingo said the FDA is urging local government units to still give priority vaccination to those who have not yet received a single dose.

“Priority pa rin natin bakunahan muna lahat ng unvaccinated,” he said.

The administration of booster shots is eyed this month.

JPV