MOSCOW (Pakistan Point News / Sputnik - 14th January, 2021) The food and Drug Administration (FDA) of the Philippines has approved the emergency use of COVID-19 vaccine developed by Pfizer and BioNTech pharmaceutical companies, FDA Director General Enrique Domingo said on Thursday.
"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," Domingo said.
According to the FDA, the decision to approve the emergency use of Pfizer/BioNTech vaccine was based on the available data, suggesting that the benefits of the vaccine use outweigh potential risks.
"Evaluation was based on current available data. The assessment ensured that the benefits outweigh the known and potential risks of the product," the regulator said.
The FDA director added that, though the vaccine was used by over five million people and few recipients had severe allergic reactions after the inoculation, the vaccination should be carried out by health care professionals who could respond to possible side effects.
"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," Domingo said.
On January 6, Carlito Galvez Jr, the chief implementer of the Philippines' COVID-19 National Task Force, said that the country planned to purchase 148 million doses of COVID-19 vaccines produced by different pharmaceutical companies, including Russia's Sputnik V vaccine developed by the Gamaleya National Center of Epidemiology and Microbiology. On January 9, the FDA said that it received a license request for the emergency use of Sputnik V vaccine.
According to Johns Hopkins University, the Philippines has confirmed 491,258 COVID-19 cases since the start of the pandemic. On Wednesday, the country registered 1,522 new COVID-19 infections over the past 24 hours.
