THE LOCAL Food and Drug Administration (FDA) has approved the emergency use of AstraZeneca Plc’s coronavirus vaccine in the Philippines, the second approval after Pfizer, Inc.
Evidence and data show it is reasonable to believe that the vaccine might be effective against the coronavirus disease 2019 (COVID-19) virus, FDA Director General Rolando Enrique D. Domingo told an online news briefing on Thursday. The benefits outweigh potential risks, he added.
The vaccine had no safety concerns and its adverse effects were “transient and mostly mild to moderate, similar to common vaccine reactions,” he said.
AstraZeneca’s vaccine has an efficacy of 70% after the first dose and requires a second dose after four to 12 weeks, Mr. Domingo said.
In a statement, the British drug maker said the vaccine could be given to people 18 years old and above.
It can be stored and handled at normal refrigerated conditions at 2 to 8 degrees Celsius for at least six months.
“This emergency use authorization (EUA) will give millions of Filipinos access to AstraZeneca’s effective, well-tolerated and simple-to-administer vaccine once supply becomes available,” AstraZeneca Philippines Country President Lotis Ramin said in the statement.
“We will continue to fulfill our commitment to provide broad and equitable access at no profit as we work with the Philippine government to pave the way for a return to normalcy and the country’s full economic recovery,” she added.
The National government, local government units (LGUs) and private sector signed an agreement to buy 17 million doses of Astrazeneca vaccines this month.
Russia’s Gamaleya Research Institute of Epidemiology and Microbiology, China’s Sinovac Biotech Ltd. and India’s Bharat Biotech also have pending applications for emergency use in the Philippines. — Vann Marlo M. Villegas