MANILA – The Philippines’ Food and Drug Administration (FDA) gave the green light Thursday to a COVID-19 vaccine jointly developed by Pfizer and BioNTech, the first to be granted an Emergency Use Authorization (EUA) in the country.
“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine. The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” FDA Director General Eric Domingo said in a statement.
He added that “the roll out of the vaccine and use in more than 5 million people worldwide has identified severe allergic reaction in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond.”
“The development of these vaccines is still ongoing. We will keep track of the progress and FDA will provide our public with the correct information on the authorized products for transparency, to aid the decision making of Filipinos,” Domingo said.
Through Executive Order No. 121 s. 2020, vaccines under development can be granted an EUA where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency, according to the FDA.
Meanwhile, the country’s vaccine czar Carlito Galvez Jr. said the government’s negotiation with Pfizer is doing well. He said there’s a possibility that the U.S. pharmaceutical company could provide the Philippines additional allocation, giving the country more or less 25 to 40 million doses.
“At natutuwa po kami dahil kasi hindi po tayo iniwan ng Pfizer at may commitment po sila na baka magkaroon po pagka nagpirmahan po tayo baka, hopefully, kung mayroon silang excess from US at other countries puwede pong mai-deliver ‘to sa atin,” he told President Rodrigo Duterte during a meeting in Malacañang on Wednesday.
Pfizer filed for EUA in the Philippines last Dec. 23. - Florenda Corpuz