FDA: COVID-19 vaccines may have full authorization in PH by early 2022

MANILA, Philippines — COVID-19 vaccines may have full authorization from the Philippines’ Food and Drug Administration (FDA) by early next year, the agency chief said Thursday.

However, no drugmaker has applied for full market authorization yet, including Pfizer, which has already secured full approval from the United States earlier this year, FDA Director-General Eric Domingo said.

“My prediction is siguro (maybe) early next year, by the first quarter, not only Pfizer, maybe several of the existing vaccines will get full approval for marketing authorization,” he said in an interview over ABS CBN News Channel.

With full authorization, the vaccines can be sold in drug stores.

FILE PHOTO: Food and Drug Administration chief and DOH Usec. Eric Domingo. INQUIRER

So far, the FDA has only granted emergency use authorizations (EUAs) to nine COVID-19 vaccine brands, including Pfizer, AstraZeneca, Sinovac, Sputnik V, Janssen, Covaxin, Moderna, Sinopharm, and Novovax’s Covovax.

Under a EUA, only the government can procure the vaccines while private firms may purchase them through a tripartite agreement.

The United States granted Pfizer full authorization in August. However, Domingo said the drug firm has yet to apply for full approval in the Philippines.

Should Pfizer apply for full authorization, it will not take long to be granted, he added.

“They haven’t applied anywhere else other than the US at this time. We did ask them and they said they were completing all of their documents and requirements,” he said.

“If they do apply here, it’s not going to take long. Kaya lang (However), they haven’t applied yet. It’s probably because the company is not yet ready to supply at baka nagko-concentrate sila sa (and maybe they are focusing on) one market at this time,” Domingo added.

KGA