MANILA – The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to the coronavirus disease 2019 (COVID-19) vaccine of AstraZeneca.
FDA Director General Eric Domingo stated that there was no safety concerns linked to the AstraZeneca vaccines after their stringent review. He said the two doses of the vaccine, administered four to 12 weeks apart, can only be received by people aged 18 and above, excluding pregnant women.
“It is decided that all conditions for an EUA are present. The benefit of using the vaccine outweighs the known and potential risks,” Domingo said in a virtual presser on Thursday.
“Ang nakitang adverse events are all very mild, similar to getting any flu injection. Karamihan ay pananakit sa lugar ng injection, konting sinat, sakit ng ulo – all easily managed,” he added.
AstraZeneca’s COVID-19 vaccine showed an average efficacy of 70 percent after receiving two required doses. It is also seen to be easier to transport and distribute as it does not need to be stored at freezing temperatures. It is the second pharmaceutical firm to be granted with EUA for its COVID-19 vaccine after Pfizer’s BioNTech.
The Philippines has procured 17 million doses of AstraZeneca’s COVID-19 vaccine through tripartite agreements with the private sector and local government units. Over 300 companies and 39 LGUs from across the country pitched in to buy the vaccine doses.
“Dahil may EUA na siya, pwede na siya gamitin ng pamahalaan. Marami ding local government units na nakikipag-tripartite agreement with the gov’t and AstraZeneca for them to be able to access this drug,” Domingo added.
The World Health Organization pointed out the product can be stored and stable in temperatures of 2 to 8 degrees Celsius. It has received approval from other regulators including in the United Kingdom, where it is already being rolled out. /PN
