FDA Authorizes Pfizer-BioNTech’s COVID-19 Vaccine for Emergency Use

by | Dec 14, 2020 | Coronavirus, COVID-19, EUA, FDA, Medical Devices, Quality, Vaccine

In a historic move on Friday afternoon, the FDA granted the first Emergency Use Authorization (EUA) to Pfizer and BioNTech’s COVID-19 vaccine for use in individuals ages 16 and older. This allows for the first COVID-19 vaccine to begin being distributed country-wide; the first shipments started rolling out from Pfizer’s Michigan facility early Sunday morning. This historic authorization comes after roughly 12 months, 300,000 US deaths, and more than 1.5 million deaths globally.1

Over the next couple of weeks 2.9 million doses of the vaccine will be distributed across the United States, with 2.9 million doses withheld for the booster dose of the two-injection system. Additionally, as a precautionary measure, a supplemental 500,000 doses are being reserved in the event of any uncontrollable circumstances causing loss of product. According to the US Department of Defense, the decision about where the vaccine goes first and how much is sent is being made with state officials. The Centers for Disease Control and Prevention (CDC) recommended that health care workers and long-term care facilities receive the initial doses first.2

Although the regulatory requirements for an EUA are vague, only requiring evidence that the product may be effective and that its potential benefits outweigh potential risks, the agency wants to assure the public that this authorization comes after an extensive review of solid evidence. Center for Biologics Evaluation and Research (CBER) Director Peter Marks, who is the FDA’s top official overseeing vaccines, stated in a press conference Saturday morning that “The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”3

While this is certainly celebratory news to end a year that has been less than jubilant, there is still more work to do in the fight against COVID-19. Moderna’s COVID-19 vaccine is next in line to be reviewed by the FDA, a second vaccine authorization would create even more chances to efficiently vaccinate the population. EMMA International has been staying on top of all the breaking COVID-19 news, including the unprecedented regulatory changes. Contact us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today!


1Johns Hopkins University of Medicine (Dec 2020) Johns Hopkins Coronavirus Resource Center retrieved on 12/13/2020 from: https://coronavirus.jhu.edu/

2Lopez, DOD News (Dec 2020) First COVID-19 Vaccine May be Distributed Next Week retrieved on 12/13/2020 from: https://www.defense.gov/Explore/News/Article/Article/2441740/first-covid-19-vaccine-may-be-distributed-next-week/

3FDA (Dec 2020) FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine retrieved on 12/13/2020 from: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This