FDA chief expects applications for market use of COVID-19 vaccines by late 2021

The chief of the Philippines' Food and Drug Administration (FDA) said on Thursday, May 6, that he expects to receive applications for market use of COVID-19 vaccines by late 2021.

In an interview with ANC's Headstart on Thursday morning, FDA Director General Eric Domingo said this as he explained that before a certificate of product registration (CPR) is issued, a vaccine company must first complete the phase 3 trials.

"Meaning, the required endpoints have already been met and the company declared that 'our phase 3 trial is completed' – safety data is very good and the efficacy data is fine. Personally, I expect the earliest applications for CPR is late this year or early next year," he added in a mix of English and Filipino.

A CPR is a certificate issued by the FDA that would allow a product to be commercially available in the market.

So far, the use of COVID-19 vaccines in the Philippines is under emergency use authorization (EUA) granted by the FDA. The Philippines has so far granted EUAs to seven vaccine companies: Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, Bharat Biotech, and Moderna.

The Philippines, which is battling one of the worst COVID-19 outbreaks in Southeast Asia, has so far inoculated 1,744,649 of its 110-million population. Vaccine czar Carlito Galvez Jr said on Tuesday, May 4, that due to India's move to focus its vaccine supplies on its own population, the Philippines may have to lower its vaccination goal to only half the population in 2021.

The government's original goal is to vaccinate 70 million people, or around 70% of its population.

Aside from the global shortage on vaccine supplies, vaccine hesitancy among Filipinos remain high, based on a Pulse Asia Research, Incorporated survey that showed that 6 in 10 Filipinos don't want to get vaccinated against COVID-19. The survey, however, was conducted before the record-high surge in cases in the country. – Rappler.com

Bonz Magsambol

Bonz Magsambol is a multimedia reporter for Rappler, covering health, education, and social welfare. He first joined Rappler as a social media producer in 2016.

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