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The Philippine Food and Drug Administration (FDA) approved on January 28, 2020, the emergency use authorization for the Covid-19 AstraZeneca (ASZD1222) vaccine in the Philippines for immunization of adults.
In a statement, AstraZeneca said that the vaccine has been approved for the active immunization of people over 18 years of age for the prevention of coronavirus disease (Covid-19). FDA clearance is for the two standard dose regimens of the vaccine.
“The decision to approve was based on an ongoing submission that included the results of an interim review of the Phase III program conducted by the University of Oxford and published in The Lancet on December 8, 2020,” the pharmaceutical firm said in a statement. .
According to interim analysis by the University of Oxford and trials conducted in Brazil, South Africa and the United Kingdom, the Covid-19 AstraZeneca vaccine “has an acceptable safety profile and has been found to be effective against symptomatic Covid-19 in this interim period. analysis of ongoing clinical trials “.
In a statement, AstraZeneca said the study showed the efficacy of the Covid-19 Vaccine AstraZeneca vaccine to be 90 percent when given in a half dose, followed by a full dose at least a month apart.
In another dosing regimen, the vaccine was 62 percent effective when given in two full doses at least one month apart.
AstraZeneca said in a separate statement that the combined analysis of both dosage regimens resulted in an average efficacy of 70 percent.
“This emergency use authorization will give millions of Filipinos access to the effective, well-tolerated, and easy-to-administer vaccine from AstraZeneca once a supply is available. We will continue to fulfill our commitment to provide broad and equitable non-profit access while we are working with the Philippine government to pave the way for a return to normalcy and the country’s full economic recovery, “said AstraZeneca Country President Lotis Ramin.
As of January 15, 39 local government units and some 300 private companies signed a tripartite agreement with AstraZeneca and the government for the acquisition of almost 17 million doses of the Covid-19 vaccine.
As of January 15, Quezon City and Makati City have AstraZeneca’s largest purchase order with 1.1 million and 1 million doses, respectively.
Local government units (LGUs) that have signed purchase agreements include the city of Manila, the city of Valenzuela, the city of Iloilo, the city of Caloocan, the city of Zamboanga, the city of Pasig, the city of Baguio, the city of Las Piñas, the city of Ormoc, the city of Parañaque, 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 the FDA to a manufacturer of Covid-19 vaccines. The first was awarded to Pfizer-BioNTech Covid-19 Vaccine (BNT162b2) on January 14.
The AstraZeneca Covid-19 vaccine can be stored, transported, and handled under normal refrigeration conditions (two to eight degrees Celsius) for at least six months. (With public relations)
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