Walgreens Doctor Luis S. Solano prepares a dose of Pfizer BioNTec’s Coronavirus Disease (COVID-19) vaccine on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.
Kamil Krzaczynski | Reuters
Pfizer and German drug maker BioNTech have initiated the process to apply for full approval of its Covid-19 vaccine in the United States. This makes the companies the first to apply for full approval in the country.
The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed millions of doses in the US, with the goal of dispensing 300 million doses by the end of July. If approved, Pfizer could market its shots directly to consumers and potentially change the pricing of its cans.
It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.
The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.
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