PH’s FDA hopes to issue emergency use authorization for Pfizer COVID-19 vaccine by Jan.

Kristine Sabillo, ABS-CBN News

Posted at Dec 28 2020 04:25 PM | Updated as of Dec 28 2020 04:35 PM

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MANILA — If all goes according to plan, the Philippine government may already issue an emergency use authorization by January for Pfizer's COVID-19 vaccine, according to the Food and Drug Administration on Monday.

“Tinataya natin na baka mga 2 weeks or 3 weeks ang itatagal nito (evaluation). At kung maisa-submit naman nila lahat ng requirements at kung may mga tanong tayo masagot naman agad, we hope by the month of January makapag-issue naman tayo ng Emergency Use Authorization,” FDA Director General Eric Domingo told ABS-CBN News in a video call interview.

(We estimate that the evaluation will last for 2 to 3 weeks. And if they are able to submit all requirements and respond to all questions, then we hope by the month of January we can issue Emergency Use Authorization.)

He said the government can already start working on a supply deal with Pfizer, but the EUA is needed to allow the importation of the vaccine.

There are also other factors to consider such as the availability of stocks and the ability of the Philippines to implement the vaccination program.

President Rodrigo Duterte recently granted the FDA the power to issue emergency use authorization for medicines that can help Filipinos during the COVID-19 pandemic. The Department of Health previously said it can shorten the regulatory approval process to 21 days.

Domingo said they received Pfizer’s application for an EUA just before Christmas Day, and evaluation of the company’s documents began on Monday.

Countries like the United Kingdom and the United States have already allowed the use of Pfizer's vaccine, which claims to have an efficacy level of around 95%, to curb the spread of COVID-19.

Domingo said the FDA has 2 groups that will evaluate the EUA application — one to look into the safety and efficacy of the vaccine, and another to check the quality and stability of the product.

The approval documents of other countries are among the requirements for an EUA.

The FDA chief said they will also ask for the questions raised by other regulatory bodies and Pfizer’s response to those to do away with redundancy, and to hasten the evaluation process.

While Pfizer was not able to run clinical trials in the Philippines to check if the vaccine is effective for Filipinos, Domingo said the company had a large number of participants at around 40,000.

He also specifically asked Pfizer to submit separate findings for Asian, Pacific Islanders and Filipino clinical trial participants to see the effect of the vaccine on similar races.

Domingo said because Pfizer is applying for an EUA, which is for medicines that are still under development, it can only be used for a public health program. Although vaccines with EUA have finished Phase 3 or large-scale clinical trials, it still has to go through Phase 4 trials or post-marketing surveillance.

“Pero yung diretso na ibebenta sa isang kumpanya o ibebenta sa botika, hindi pa mangyayari yun. Mangyayari lang yun 'pag may full license na ang isang bakuna,” he explained.

(But for the vaccine to be sold to a company or to a pharmacy, that can’t happen yet. That will only happen once the vaccine gets a full license.)

He said the DOH can also partner with private companies to make the vaccine available to more people.

The Philippines has recorded 470,650 confirmed COVID-19 cases, as of Monday, including 22,746 active infections, 9,124 deaths, and 438,780 recoveries.

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