Roque: EUA filed for Pfizer-BioNTech COVID-19 vaccine

Presidential spokesperson Harry Roque on Saturday said that Pfizer-BioNTech had applied for an emergency use authorization (EUA) for its vaccine, which may allow it to be the first to be made available in the country.

“On Pfizer, Food and Drug Administration (FDA) Director-General Rolando Domingo confirmed that it filed for Emergency Use Authorization (EUA) last 23 December 2020,” Roque said in a statement.

An official of the Department of Science and Technology said the vaccine will be available by the second quarter of 2021 if the EUA will be issued to them in the same period.

Meanwhile, Roque said that it would take the Food and Drug Administration 21 days to approve the application.

“It will take FDA 21 days to evaluate and approve the EUA but vaccination would start as soon as stocks become available,” Roque said.

In his report to the President, FDA Director-General Eric Domingo explained that vaccines that had been approved by a stringent regulatory authority would only need to pass minimal requirements.

“Pag naman po galing sa stringent regulatory authority… minimal na lang po ‘yung additional requirements natin. Ano na lang po stability sa Pilipinas, sa kilima natin, and of course some information lang po sa clinical trial nila… na ‘yung efficacy niya and safety in an Asian population is also similar to the general population,” he said. — DVM, GMA News