AstraZeneca vaccine won't get FDA approval sans DOST endorsement —DOH

The COVID-19 vaccine developed by British firm AstraZeneca and Oxford University will not get the Food and Drug Administration (FDA) approval if it is not cleared by a government panel of vaccine experts, Health Undersecretary Maria Rosario Vergeire said Friday.

“Kailangan approved ng VEP (Vaccine Experts Panel) at Ethics Board and vaccine for you to advance to the FDA process,” Vergeire said in a virtual forum.

Vergeire was responding to a question regarding AstraZeneca's vaccine securing approval from the Ethics Board even if it is yet to be approved by the VEP, which is under the Department of Science and Technology (DOST).

Vergeire said AstraZeneca's vaccine is not bypassing any regulatory process since requirements set by the VEP and the Ethics Board vary.

“Minsan, it also depends on how fast these manufacturers and partners respond to the queries being made by the Philippine government,” she said.

“Meron pong kaunting delay minsan sa pag-respond,” Vergeire added.

FDA Director General Eric Domingo earlier explained that VEP reviews Phases 1 and 2 of clinical trials of the candidate vaccine, while the Ethics Board evaluates the selection for participants for clinical trials and safeguards that the drugmaker provided for them.

President Rodrigo Duterte has already issued an executive order allowing the FDA to issue emergency use authorization (EUA) for COVID-19 vaccines that it finds efficacious and have secured EUA from reputable FDA units abroad.

The Philippines government has already inked a tripartite deal with the private sector and AstraZeneca where the private sector purchased 2.6 million doses of AstraZeneca's vaccine to be donated to the Philippine government.

The 2.6 million doses are good for one million people.

The Philippines has recorded 435,413 COVID-19 cases as of Thursday, December 3, 2020. Of this number, 399,325 recovered while 8,446 died.

The number of active COVID-19 cases is at 27,642. —KBK, GMA News