Metro Manila (CNN Philippines, January 27)— Experts reviewing the emergency use application of British drugmaker AstraZeneca have submitted “favorable” recommendations for the coronavirus vaccine, the Food And Drug Administration said Wednesday ahead of the expected release of its final decision on authorization.
Speaking to CNN Philippines, FDA Director General Eric Domingo said the expert panels have wrapped up their evaluation of the vaccine, adding that the agency would be “running overtime” to finalize the decision within the week.
“They [panels] gave their recommendations yesterday, and I’m just flipping through them. They’re quite positive, they’re very favorable,” Domingo told The Source.
“So I’m just really going to look at the data now— both from the technical quality side and then the safety and efficacy side and recommendations— and hope to finish going through this today or maybe tomorrow,” he added.
The British manufacturer applied for emergency use authorization of its vaccine in the country early in January. Domingo previously noted that the review of the product may be faster, as it has already gained approval in the United Kingdom, considered as a stringent regulatory authority.
“We know that other experts have seen it, and that we can rely upon the findings of these experts. So we just ask a little more local questions, things that are very specific to the Philippine situation for clarification,” the FDA chief noted.
The Philippines earlier secured around 2.6 million doses of AstraZeneca’s vaccine through the help of the private sector, with the second batch of procurement also in the works. A number of local government units have likewise entered into tripartite deals with the national government and AstraZeneca to secure doses of the product.
So far, only Pfizer-BioNTech's COVID-19 vaccine has been approved for emergency use in the Philippines. Russian company Gamaleya Research Institute, Chinese drug maker Sinovac Biotech, and the distributor of India-developed vaccine COVAXIN also have pending EUA applications before the local FDA.
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