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Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the PfizerBioNTech COVID19 Vaccine to allow for use of a single booster dose, to be administered at least
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Pfizer and BioNTech submit refers to the regulatory submissions made by Pfizer and BioNTech to health authorities regarding the development, approval, and updates of their COVID-19 vaccine.
Typically, the companies involved in the vaccine's development, such as Pfizer and BioNTech, are required to file these submissions. Additionally, any entities involved in the production or distribution might also be required to comply with filing regulations.
Filling out a Pfizer and BioNTech submission involves completing the necessary forms provided by regulatory authorities, including detailed information about the vaccine's clinical trials, safety, efficacy data, and manufacturing processes.
The purpose of the submissions is to obtain regulatory approval for the vaccine, ensuring that it meets safety and efficacy standards before being used in the public.
The information that must be reported includes clinical trial data, adverse event reporting, manufacturing quality control processes, and any relevant scientific data that supports the vaccine's safety and efficacy.
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