PH approves AstraZeneca’s COVID-19 vaccine for emergency use

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Metro Manila (CNN Philippines, January 28) — The Philippine Food and Drug Administration has approved AstraZeneca's coronavirus vaccine for emergency use, making it the second product to be granted authorization in the country.

FDA Director General Eric Domingo on Thursday said there were no safety concerns linked to the AstraZeneca vaccines after their stringent review. He said the two doses of the UK-manufactured 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... 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 said in a media briefing.

[Translation: All adverse event monitored were all mild, similar to reactions to other flu shots. They only complained of pain on the injected area, slight fever, and headache. They are all manageable.]

The vaccine, developed with the University of Oxford, showed an average efficacy of 70% after receiving two required doses, AstraZeneca said in November. However, the FDA chief said the efficacy rate for the first dose of AstraZeneca is at 70%, but it improves after the second dose is administered.

AstraZeneca’s vaccine is seen to be easier to transport and distribute as it does not need to be stored at freezing temperatures. The World Health Organization had pointed out the product can be stored and is 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.

RELATED: AstraZeneca vaccine comes with advantage of easier storage, WHO chief scientist says

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.

Domingo said the national government and all other parties involved in tripartite deals can now deploy the vaccines for emergency use. He, however, stressed that AstraZeneca vaccines cannot be commercially distributed in pharmacies, clinics, or hospitals without a marketing authorization and certificate of product registration.

"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," he said.

[Translation: With the EUA, it can now be used by the government. Several local government units entered into a tripartite agreement with the government and AstraZeneca so they can access the drug.]

Pfizer-BioNTech's COVID-19 vaccine was the first to be issued an EUA in the Philippines. Russian company Gamaleya Research Institute, Chinese drugmaker Sinovac Biotech, and the distributor of India's COVAXIN also have pending EUA applications before the FDA.

One million doses of COVID-19 vaccines intended for healthcare workers, vaccinators, and other frontliners are set to arrive in February, according to vaccine czar Carlito Galvez Jr. Presidential spokesperson Harry Roque on Thursday said vaccines from Pfizer or AstraZeneca could arrive in the country that same month through the global COVAX facility. Testing czar Vince Dizon said immunization may start by end of February or March.