THE Food and Drug Administration in the Philippines (FDA) approved on January 28, 2020 the emergency use authorization to the Covid-19 Vaccine AstraZeneca (ASZD1222) in the Philippines for the immunization of adults.
In a statement, AstraZeneca said the vaccine has been approved for the active immunization of individuals 18 years old and above for the prevention of the coronavirus disease (Covid-19). The FDA authorization is for the two standard dose regimens of the vaccine.
"The decision to approve was anchored on a rolling submission which included results of an interim analysis of the Phase III programme conducted by the University of Oxford and published in The Lancet on December 8, 2020," the pharmaceutical firm said in a statement.
Based on the interim analysis by Oxford University and the trials conducted in Brazil, South Africa, and the United Kingdom, the Covid-19 Vaccine AstraZeneca "has an acceptable safety profile and has been found to be efficacious against symptomatic Covid-19 in this interim analysis of ongoing clinical trials."
In a statement, AstraZeneca said the study showed that the vaccine efficacy of Covid-19 Vaccine AstraZeneca was at 90 percent when given as a half dose, followed by a full dose at least one month apart.
In another dosing regimen, the vaccine showed 62 percent efficacy when given as two full doses at least one month apart.
AstraZeneca said in a separate statement that the combined analysis from both dosing regimens resulted in an average efficacy of 70 percent.
"This emergency use authorization will give millions of Filipinos access to AstraZeneca's effective, well-tolerated, and simple-to-administer vaccine once supply becomes available. 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," AstraZeneca Country President Lotis Ramin said.
As of January 15, 39 local government units and some 300 private companies have signed a tripartite agreement with AstraZeneca and the government for the procurement of nearly 17 million doses of Covid-19 Vaccine.
As of January 15, Quezon City and Makati City have the largest purchase order from AstraZeneca with 1.1 million and 1 million doses, respectively.
Among the local government units (LGUs) that have signed purchase deals are City of Manila, Valenzuela City, Iloilo City, Caloocan City, Zamboanga City, Pasig City, Baguio City, Las Piñas City, Ormoc City, Parañaque City, Ilocos Norte, Oroquieta City, Vigan City, Navotas City, Muntinlupa City, Bacolod City, Mandaluyong City, San Juan City, Taal City, Davao City, Taguig City, and Pasay City.
This is the second EUA granted by FDA to a Covid-19 vaccine manufacturer. The first was granted to Pfizer-BioNTech Covid-19 Vaccine (BNT162b2) on January 14.
The Covid-19 Vaccine AstraZeneca can be stored, transported, and handled at normal refrigerated conditions (two to eight degrees Celsius) for at least six months. (With PR)