FDA grants emergency use authorization for AstraZeneca's COVID-19 vaccine
The Philippine Food and Drug Administration (FDA) has approved the emergency use authorization for the vaccine against coronavirus disease manufactured by United Kingdom's AstraZeneca, an official said on Thursday.
FDA director general Eric Domingo, in the "Laging Handa" public briefing, said that the EUA approval was made after a thorough review of the currently available data by the Filipino medical and regulatory experts.
"It is decided that all conditions for an EUA are present, those required conditions...that the benefit of using the vaccine outweighs the known and potential risks," he said.
Based on interim data from the ongoing Phase 3 trials when taken in its entirety, he said the first dose of AstraZeneca's COVID-19 vaccine has an efficacy rate of 70 percent and this can still go up.
He said the vaccine regimen consists of two equal standard doses of 0.5 ml each given four to 12 weeks apart.
As to to the possible adverse effects of the UK brand vaccine, Domingo said they were "transient and mostly mild to moderate, similar to common vaccine reactions."
"No specific safety concerns were identified and of course, it must be noted, this reflects limited follow up. And possible that more adverse events may emerge that’s why close monitoring and surveillance is needed after immunization," he explained.
With the EUA, he clarified that the AstraZeneca vaccine cannot be used commercially and only the Department of Health, the National Task Force Against COVID-19 or the DOH or NTF-designated agencies are authorized to procure the vaccine.
The authorized agencies could be the local government units, public and private hospitals, and other partners of the DOH and the NTF.
Some 39 LGUs and some big companies in the country have signed tripartite agreements with the national government for the purchase of AstraZeneca COVID-19 vaccine even prior to FDA's EUA.
In the absence of an agreement with the DOH or NTF, the FDA chief said AstraZeneca will provide the appropriate cold chain requirement, which can also be shared with the responsible agencies.
The validity of the EUA is only within the duration of the declared public health emergency due to COVID-19 or upon marketing authorization, he said.
AstraZeneca, which applied for emergency use on January 6, was the second pharmaceutical company that was granted EUA in the Philippines. The first was America's Pfizer.
The other pharmaceutical companies that have applied for EUA are Russia's Gamaleya, the producer of Sputnik COVID-19 vaccine, China's Sinovac, and India's Bharat Biotech.
Domingo said his office is still waiting for other companies to apply for the EUA, such as Moderna, Clover, and Janssen. Celerina Monte/DMS
