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FDA sees AstraZeneca’s EUA out by end of January



The Food and Drug Administration eyes the issuance of emergency use authorization (EUA) to AstraZeneca by end of January, Director-General Eric Domingo said Friday.

During the Senate’s inquiry on the government’s COVID-19 vaccine rollout, Domingo said the pharmaceutical firm has yet to submit other requirements and provide answers to the clarifications made by the vaccine experts panel.

“’Yung AstraZeneca, end of January po ang target,” Domingo said.

“Basta sumagot sila sa kanilang mga requirement at mga katanungan sa kanila siguro po mga 10 days kaya na ‘yan, one week or seven to 10 days,” he noted.

Currently, the country’s regulatory body has only approved the EUA application of Pfizer COVID-19 vaccine.

Other EUA applications in the country include the following: Russian-made Gamaleya, Chinese-made Sinovac, and India-based Bharat Biotech.

Vaccine Czar and National Task Force chief implementer Carlito Galvez Jr. said the government might get “few hundred thousands” of COVID-19 vials by March.

This will be composed of jabs from different pharmaceutical companies such as Pfizer-BioNTech, Sinovac, AztraZeneca, Novovax, Johnson and Johnson, Gamaleya, and Bharat BioTech.

In the same hearing, two senators called on the FDA to simplify the process for donated COVID-19 vaccines in the Philippines.

Senator Francis Tolentino cited an example where an association would like to donate vaccines that were already granted with EUA to a certain municipality.

Domingo said all medicines will need to secure clearance if an EUA was really issued to the said vaccine once it pass though the Bureau of Customs.

He further explained that the medicines or vaccines in particular will be referred to the Department of Health then the department will receive in behalf of the local government unit.

After which, the DOH may apply for a permit with the FDA for its emergency use.

Senator Panfilo Lacson joined Tolentino’s call, saying this procedure is “critical” as there are many associations that may donate vaccines to some LGUs.

“Would it not be more practical to ensure the goods reach the intended recipients directly under strict supervision and guidance by health authorities, instead of coursing the goods through the Department of Health and having the DOH distribute them?” he said.

“Besides, many local government units like Baguio City already have their own cold storage facilities for the vaccines, as their local leaders had the foresight to act accordingly. Allowing such donated vaccines to go directly to the LGUs instead of having to go through the logistical requirements of the DOH and Inter-Agency Task Force on COVID-19 would also avoid the prospect of double handling and additional costs,” he added.

Galvez said they are open to Lacson’s suggestion and they will conduct time and motion rehearsal to determine if the LGUs are capable of handling the vaccines.