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FDA approves manufacturing change for Pfizer mRNA COVID19 vaccine

DTMT Network

The United States Food and Drug Administration has approved a manufacturing change for the Pfizer-BioNTech mRNA COVID-19 vaccine to include a formulation that uses a different buffer on December 16, 201, a statement released by the Organisation said.

Buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability, the statement added.

This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers it said.

According to FDA, this formulation of the Pfizer-BioNTech vaccine does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses.

Meanwhile, the FDA-approved Pfizer’s COVID-19 mRNA vaccine and Pfizer-BioNTech COVID-19 Vaccine authorised for Emergency Use Authorisation (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably, FDA informed.
    

 


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