FDA to decide Pfizer application status on Jan. 10


Food and Drug Administration (FDA) Director General Eric Domingo announced in a briefing that the FDA is set to decide on January 10 if the Pfizer Coronavirus Disease 2019 (COVID-19) vaccine will be approved.

According to the FDA, it has given Pfizer 2 days to answer the questions of the vaccine experts panel.

Pfizer is the first vaccine manufacturer to apply for an emergency use authorization (EUA) for their developing vaccine. Through the EUA, the process of the regulatory approval of the vaccine will be hastened despite being under development.

The United Kingdom, United States of America, and Singapore have initially given the said manufacturer an EUA as well as an Emergency Use Validation by the World Health Organization (WHO).
WHO also recommended that the 2 doses of the Pfizer vaccine must be consumed within 3 to 4 weeks.

The manufacturer AstraZeneca is also expected to apply for an EUA after acquiring an authorization from the UK while the clinical trials of Janssen Pharmaceuticals is set to begin in the next week following FDA’s approval of their application.

Meanwhile, the FDA is still looking into the trial applications of the Chinese companies, Sinovac and Clover. – Report from Mark Fetalco

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