FDA: COVID-19 vaccine emergency approval likely in January, arrival in PH possible by March 2021

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Metro Manila (CNN Philippines, December 3) — The country's Food and Drug Administration is hopeful COVID-19 vaccines may be available in the Philippines by March next year following the new guidance to allow emergency use of unregistered drugs for coronavirus.

FDA Director General Eric Domingo on Thursday said once a vaccine manufacturer applies for Emergency Use Authorization, the regulatory body will complete the review on the drug's safety and efficacy within 21 to 28 days if the applicant presents all the necessary documents. It will also seek the help of the vaccine experts panel to study the documents before deciding.

"Kapag nag-apply sila dito sa atin, maaaring by first few weeks of January, mayroon na tayong maibigay na Emergency Use Authorization at baka mapaaga nang kaunti," the official said in a media briefing. "Baka magkaroon ng chance na mga March ay magkaroon na ng bakuna dito sa Pilipinas."

[Translation: Once they apply, we may be able to issue the Emergency Use Authorization by January. There's a chance the vaccine will be here in the Philippines by March.]

This timeline is similar to the demand of President Rodrigo Duterte that vaccines should be available before the second quarter of 2021, Presidential Spokesperson Harry Roque said.

However, Domingo said this will depend on the available supply, delivery, and distribution of the vaccines in the country.

Roque previously said the Philippines will procure vaccines from China's Sinovac, Pfizer from US, UK's AstraZeneca, and Sputnik V from Russia's Gamaleya. The Philippines has so far only secured 2.6 million doses from AstraZeneca while other pre-purchase talks are ongoing.

Requirements

The FDA said the applicant first needs to present the EUA from the regulatory agency in their country or proof of their inclusion in the World Health Organization's emergency use list before applying in the Philippines. The FDA will use the available data in its evaluation.

"Isa sa ating kundisyon, unang-una, dapat may approval na siya ng EUA sa bansang pinanggalingan niya o sa isang FDA counterpart natin na alam nating strict ang regulation or sa WHO pre-qualification," he said.

[Translation: Our first condition is that it should have an EUA from its origin country, from a strict FDA counterpart, or WHO pre-qualification.]

The applicant must also approve a contract that they will complete the vaccine's development process until its licensing.

Domingo sees the US' Pfizer/BioNTech and China's Sinovac and Sinopharm applying in the Philippines soon, since they have already secured EUAs from their countries. He added Moderna and AstraZeneca may follow after they announced plans to apply for it in their countries as well.

The FDA said its evaluation will have two parts: the study on the drug's quality, safety, and efficacy. It said the granting of the EUA will be based on its efficacy based on available evidence and if the possible benefits of the vaccine will outweigh the risk.

"In the absence of an approved or licensed product, maaari tayong magbigay ng (We can give) emergency use authority," Domingo explained.

The agency will also request for data on the product's stability, such as transportation and storage requirements. They will also check if the vaccine has been used on Asians during the clinical trial phase to determine if it will work on Filipinos.

FDA said the power to issue emergency authorization will only cover coronavirus vaccines and drugs during the pandemic for the public health program.

Safety

Since the granting of an EUA is a "risk-based" way to evaluate unregistered drugs, Domingo said there may be possible side effects after vaccination. This is the reason the FDA, in partnership with the Department of Health, is strengthening its post-monitoring and surveillance capabilities. It will also be in touch with the FDA of other countries.

Domingo assured the public an urgent review will be conducted if any serious adverse event happens after vaccination, even if there is no proof yet it was caused by the vaccine.

"Whether or not sigurado tayo na connected iyan sa bakuna o hindi, kailangan i-report agad iyan. Then the DOH and FDA will do an investigation. Tatanungin din ang ibang FDA, magko-consult din tayo sa WHO. Then we'll make a decision whether we'll pause, stop, or continue the vaccination," he said.

[Translation: Whether or not we're sure it's connected to the vaccine, it needs to be reported. The DOH and FDA will look into it. We'll ask the FDA in other countries if they monitored a similar effect. We will also consult with the WHO. Then we'll decide if we will pause, stop, or continue the vaccination program.]

The country's COVID-19 task force is looking to administer vaccines to at least 60 million Filipinos to achieve herd immunity, where virus transmissions will be limited. Vaccine czar Carlito ​Jr. Galvez earlier said a number of provinces will receive different types of vaccines, which will be chosen with logistics in mind.

The vaccination program will last for three to five years for the more than 100 million Filipinos.