FDA: COVID-19 vax makers may apply for product registration by late this year

FILE PHOTO: Vials labeled “AstraZeneca COVID-19 Coronavirus Vaccine” and a syringe are seen in front of a displayed AstraZeneca logo in this illustration taken March 10, 2021. REUTERS/Dado Ruvic/Illustration

MANILA, Philippines — The Food and Drug Administration (FDA) expects the earliest possible time for a vaccine manufacturer to apply for a certificate of product registration (CPR) of its COVID-19 vaccine in the Philippines could be by late this year or in early 2022.

“Personally, I expect the earliest probably na may mag-a-apply for a CPR would be late this year or early next year. So once a product is registered, that one single product is registered, all the EUAs will be phased out na,” FDA Director-General Eric Domingo said in an interview with ABS-CBN News Channel (ANC) on Thursday.

In a text message to INQUIRER.net, Domingo said pharmaceutical companies that are most likely to be the first to apply for a CPR are the United States-based drugmakers Pfizer and Moderna and the British-Swede firm AstraZeneca.

Domingo explained that once a CPR is granted, the product can then be made commercially available in the market.

The FDA chief added in his ANC interview that a company has to first complete its phase 3 trials and finish all the required “endpoints” before securing a CPR for marketing authorization of its product.

“We will see, of course, dapat the safety data is (the safety data should be) very good and the efficacy data is high,” he said.

The drug regulator has so far granted emergency use authorization (EUA) for the COVID-19 vaccines of Pfizer-BioNTech, AstraZeneca, Sinovac Biotech, the Gamaleya Institute, Janssen, Bharat Biotech, and Moderna.

The FDA earlier explained that a EUA is only being issued for unregistered vaccines during a public health emergency and is not equivalent to a CPR or marketing authorization.

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/MUF