The Food and Drug Administration (FDA) has approved the application and granted a Certificate of Product Registration (CPR) for the Covid-19 vaccine Comirnaty.
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According to the European Medicines Agency, Comirnaty contains tozinameran, which is an mRNA molecule with instructions for producing a protein from the original strain of SARS-CoV-2.
The FDA said in its advisory on Monday, June 26, that the approval is a "significant milestone" that marks a crucial step in the country's fight against the virus.
"On 21 February 2023, Pfizer, Inc. submitted CPR application under Monitored Release (MR) for their Covid-19 vaccine. The application was processed in line with FDA Circular No. 2022-004, Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 'Establishing Facilitated Registration Pathways for Drug Products including Veccines and Biologicals,'" FDA said.
The CPR was issued with a five-year validity after thorough evaluation, clinical trials, and assessment of all available data.
The FDA encouraged the public to remain confident in its regulatory process and to rely on trusted information about Covid-19 vaccines.