Davao City needs to wait for FDA registration of COVID-19 vaccine before getting access

Davao City Mayor Sara Duterte (File photo by ARJOY CENIZA / Phlippine Daily Inquirer)

DAVAO CITY, Davao del Sur, Philippines — Mayor Sara Duterte Carpio said the city government here has not stopped sending letters to vaccine makers around the world to get direct access to COVID-19 vaccines,  but only one pharmaceutical company — Pfizer — had so far applied for emergency use authorization (EUA) with the Philippine Food and Drug Administration (FDA).

The mayor referred to the statement made by Health Undersecretary Maria Rosario Vergeire that only the national government could benefit from the EUA that would be issued by the FDA.

For the local government to directly access the vaccine, it has to secure a certificate of product registration (CPR) first, which could only come after they completed the clinical trials. Vergeire also said the EUA was issued only while the vaccine development was being completed.

Carpio said she had earlier written to Pfizer for direct access to the vaccine. But the company replied that it would only negotiate with the Department of Health (DOH).

Asked when the city was hoping to get the vaccine, the mayor said: “When a vaccine has CPR and if the maker will sell directly to the LGU.”

Earlier, she explained that, because there was no eligible vaccine approved for release yet, all current inoculations were only for emergency use.

The company she earlier talked to encouraged the city government to participate in the Phase 3 clinical trials to have access to the vaccines for emergency cases.

“We wait [which vaccine maker] will be given EUA by the national government. But as I understand, no one has applied [for EUA yet] except for Pfizer. Once they would be issued authorization, we will start talking,” Carpio said on Monday over the Davao City Disaster Radio.

“What are our plans for the vaccines? We’ve been sending letters to vaccine developers,” she said. “Another one replied [after Pfizer] — same answer. So we are left with two or three vaccine makers,” she said. “We are trying to reach out to them [to ask] if they will sell to the LGU. Once they say they will, we will start talking while waiting for their application for EUA.”

Recently, President Rodrigo Duterte defended the Presidential Security Group (PSG) for its controversial use of a vaccine still not registered with the FDA. In passing, he mentioned the country’s dilemma about the vaccine.

“If others say I’m protecting ([he PSG]… why would I? Why would I not wait for [FDA Director General Rolando Enrique] Domingo to come out? You know why? Up to now, it’s only Pfizer that has submitted [a EUA application] to the FDA,” he said, speaking partly in Filipino.

“Don’t you know that General [Carlito] Galvez [chief implementer of the government’s COVID-19 response] has been having a hard time looking for one, and now he has found light at the end of the tunnel. And he says that the earliest is March,” Duterte added.

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