Pfizer and BioNTech apply for a complete FDA approval for COVID-19 vaccine

People across the globe started to get inoculated for coronavirus in December 2020. This was when a number of pharma companies including Pfizer/BioNTech had received an approval for the emergency use of its vaccine. But then the first preference was given to the health care workers. Later it was given to the senior citizens and now slowly the age slot has been expanded to people over 18 years as well. But eve children need to be inoculated so they are also protected from the virus. Pfizer/BioNTech has initiated an application which towards the Food and Drug Administration for a complete approval of its COVID-19 vaccine for people ages 16 years and older.

This will become the first COVID-19 vaccine in the United States to be analysed for a full approval by the FDA. The mRNA two-shot vaccine by Pfizer is currently being used in the United States under emergency use authorization from the FDA. The companies have also said that nearly 170 million doses of the vaccine have been distributed in the United States.

Albert Bourla, the chairman and chief executive at Pfizer said that they have made a phenomenal progress since the month of December in terms of delivering the vaccine to millions of Americans. Bourla added that they are looking forward to work with the FDA to complete the submission and is focusing on retrival of the regulatory approval of the vaccine in the upcoming months. For the complete approval the pharma giant has submitted a Biologics License Application which is also known as the BLA. The vaccine manufacturers here submit the data on the actual manufacturing process along with additional facilities and information.

The manufacturers will also have to submit the pre-clinical and clinical trial data. The data is expected to be submitted to the FDA in the upcoming weeks. After all the required information is submitted, it will be up to the FDA to decide.

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