AstraZeneca applies for FDA emergency approval of its COVID-19 vaccine

The Food and Drug Administration (FDA) said on Wednesday, January 6, that drug maker AstraZeneca has submitted an application for emergency approval of its COVID-19 vaccine in the Philippines.

“They did. Just now,” FDA Director General Enrique Domingo confirmed to Rappler in a text message on Wednesday afternoon. 

AstraZeneca’s application is the second to be filed with the FDA, following Pfizer’s submission to the agency last December 23. The application brings AstraZeneca a step closer to allowing Filipinos access to its vaccine within the year. 

With AstraZeneca’s submission now with the FDA, regulators will spend about a month reviewing trial data and other information to determine the quality, safety, and efficacy of its COVID-19 vaccine on the Philippine population. 

AstraZeneca was recently granted emergency approval in the United Kingdom, making it the first country to roll out the vaccine for public use. 

Why this matters

AstraZeneca’s filing is timely and strategic considering the company is the only firm to sign solid tripartite agreements with the national government, local government units, and private sector in the Philippines. 

This includes a purchase deal closed by the private sector and national government for 2.6 million doses, as well as a separate deal signed by Quezon City for 750,000 doses. 

Apart from this, Presidential Adviser for Entrepreneurship and Go Negosyo founder Joey Concepcion earlier said negotiations for a second batch were underway as over 200 companies “and counting” pledged to purchase and expressed their interest in the vaccine.

Vaccine performance

The company’s vaccine is among those at the forefront of vaccine development. 

Early analysis of clinical trial results showed an average efficacy of about 70%. On the higher end, the vaccine was seen to be 90% effective in participants who were given a half dose, followed by a full dose. This was compared to 62% efficacy seen in participants who were given two full doses. 

Its vaccine can be transported and handled "at normal refrigerated conditions" of between 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for at least 6 months, making it compatible with the Department of Health (DOH) storage facilities. – Rappler.com

Sofia Tomacruz

Sofia Tomacruz covers foreign affairs and is the lead reporter on the coronavirus pandemic. She also writes stories on the treatment of women and children. Follow her on Twitter via @sofiatomacruz. Email her at sofia.tomacruz@rappler.com.

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