FDA: Pfizer vaccine needs full Philippines approval

MANILA, Philippines — Pfizer-BioNtech will have to apply for a Certificate for Product Registration (CPR) for its COVID-19 vaccines to be given full approval to be used in the Philippines, the Food and Drug Administration (FDA) said yesterday.

According to FDA director general Eric Domingo, once the CPR is granted, the vaccine can be procured by the private sector, paving the way for commercial availability. Currently, only the national government is allowed to purchase the vaccines because they are under emergency use authorization (EUA).

“This will increase public confidence in our vaccines because they can see that the clinical trials are complete, it has undergone thorough review and has passed safety and efficacy standards,” Domingo said.

The FDA expects Pfizer-BioNtech to submit an application in one to two months, while it takes the FDA another month to come up with a decision.

Last Monday, the US-FDA approved Pfizer-BioNTech’s COVID-19 vaccine to be commercially available for individuals aged 16 and up. It has been available in the US under EUA since Dec. 11, 2020.

Malacañang said this will likely lead to greater availability of the jabs and boost the country’s fight against the disease.

“The Philippine FDA has a policy to quickly approve the commercial use of vaccines and medicines that have approval from stringent FDAs like the United States. Well, Pfizer will become commercially available. That’s why in a little time, we can buy it in our drugstores, if that is your preferred brand,” presidential spokesman Harry Roque said.

The Philippine FDA has also granted EUA for the Russian-made single-dose Sputnik Light vaccine.

“A single-shot Sputnik Light COVID-19 vaccine has efficacy higher than that of many foreign two-dose vaccines and enables to vaccinate more people in a shorter time frame,” Russian Direct Investment Fund (RDIF) CEO Kirill Dmitriev said.

According to the Russian Ministry of Health, Sputnik Light “was proven effective against all new strains of coronavirus,” with its safety “demonstrated by the real-world vaccination data in a number of countries.”

“In particular, the data from the Ministry of Health of the Buenos Aires province (Argentina) shows 78.6-83.7 percent efficacy among the elderly. In Paraguay, Sputnik Light is 93.5 percent effective during the ongoing vaccination campaign, “ the Ministry said.

In March 2021, Gamaleya’s two-dose Sputnik V vaccine was approved in the Philippines under EUA. – Helen Flores, Pia Lee-Brago