AstraZeneca’s Covid-19 vaccine gets FDA emergency use authorization

MANILA, Philippines — The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the Covid-19 vaccine of British drugmaker AstraZeneca.

“After a thorough review of the currently available data by our medical and regulatory experts, the FDA is granting an emergency use authorization to the Covid-19 vaccine of AstraZeneca,” FDA Director General Eric Domingo announced in a Laging Handa public briefing on Thursday.

“It is decided that all conditions for an EUA are present and the benefit of using the vaccine outweighs the known and potential risks,” he added.

AstraZeneca is the second vaccine to have secured an EUA in the country, after Pfizer-BioNTech’s Covid-19 vaccine.

The vaccine has an efficacy rate of 70% after the first dose, based on the interim data from the ongoing Phase 3 trials. The efficacy rate after the second dose is still being determined.

Domingo said the Philippines would follow the standard regimen of administering two doses of the vaccine, given four to 12 weeks apart.

The vaccine was found to be “very good” in preventing severe symptoms of Covid-19, Domingo said, pointing out that those who took part in the trial only had mild to moderate disease symptoms.

“Yung data naman ng AstraZeneca shows that it is very good in preventing severe Covid-19 [symptoms]. Halos 100% din. Kaya lang, syempre, medyo maliit pa ang datos nila at maa-update pa yan as we get more data on the people included in the clinical trial,” he said.

(The data of AstraZeneca shows that it is very good in preventing severe Covid-19 symptoms. Almost 100%. However, their data is still limited and will still be updated as we get more data on the clinical trial people.

Meanwhile, adverse effects of the vaccine are “very mild,” Domingo said.

“Ang nakitang adverse effects niya are all very mild, very similar to getting any flu injection na karamihan ay pananakit sa lugar ng injection, kaunting sinat, kaunting sakit ng ulo that are all transient and easily managed,” he said.

(Its adverse effects were all very mild, very similar to getting any flu injection, mostly pain at the injected part, slight fever, a slight headache that is all transient and easily managed.)

AstraZeneca does not require sub-zero freezers for its storage as it can be stored at 2 degrees Celsius to 8 degrees Celsius, which can be achieved in regular refrigerator temperatures.

“The advantage of this vaccine is that it’s stored at 2 degrees to 8 degrees. Hindi siya masyadong maselan, at madali siyang ma-transport at i-store sa lugar ng pagbabakunahan,” Domingo said.

(The advantage of this vaccine is that it’s stored at 2 degrees to 8 degrees. It is not very picky, and it can easily be transported and stored at the vaccination site.)

The national government said about 300 companies and 39 local government units had signed a tripartite agreement to secure 17 million doses of vaccines of the AstraZeneca vaccine.

READ: PH gov’t, LGUs, private firms ink deal for 17-M doses of AstraZeneca vaccines

Three companies are still waiting for their EUA approval from the FDA:  Russia’s Gamaleya Institute, China’s Sinovac, and India’s Bharat Biotech.

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