The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for ages 16 and up, now marketed as Comirnaty, previously known as the Pfizer-BioNTech COVID-19 Vaccine. An Emergency Use Authorization (EUA) is still in effect for the adolescence of ages ranging from 12-15, and for the administration of the third dose for immunocompromised individuals. Even without formal FDA approval, the vaccination that has already been distributed to millions of people under the EUA has been subjected to rigorous, scientific standards with close monitoring. FDA Commissioner Janet Woodcock, M.D. said, “…the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

A vaccine for COVID-19 was expedited through the required phases and steps to save the lives that couldn’t overcome the disease without it. Comirnaty has been through every FDA standard process for reviewing the quality, safety, and effectiveness of medical products. The data and information included in the submissions from Pfizer-BioNTech were evaluated in the form of a biologics license application (BLA). For Comirnaty specifically, the BLA included extensive up-to-date data in addition to information that was previously submitted for the EUA, such as preclinical and clinical data, details describing the manufacturing process, vaccine testing results for quality, and regular inspections of manufacturing locations1.

To offer additional confidence in the FDA’s decision for approving Comirnaty, the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. offers the following, “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.” As members of the public, it is in our best interest to have confidence in those healthcare leaders employed by the FDA whose responsibility it is to maintain the highest standards for the sake of promptly, safely, and effectively ending this health crisis1.

Attaining FDA approval in the healthcare industry is not easy and will never be easy, because the fate of public safety is always a top priority. Experts who know what the FDA expects to review are essential to streamlining any pathway to market approval. Here at EMMA International, there is an experienced team that has developed successful means of FDA interaction, from application submissions to direct communication. Feel free to reach out today via phone at 248-987-4497 or email at info@emmainternational.com to learn more!

[1] FDA NEWS RELEASE (2021) FDA Approves First COVID-19 Vaccine, Retrieved on 24 August 2021 from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Zach Nies

Zach Nies

Quality Engineer (Co-Op) - Mr. Nies has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Nies is completing a Bachelor of Engineer degree in Biomedical Engineering from Wayne State University.

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