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BlogOn August 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine for individuals older than 16, making it the first COVID-19 vaccine to receive full FDA approval.FDA grants full approval of Pfizer COVID-19 Vaccine
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Blog
FDA grants full approval of Pfizer COVID-19 Vaccine
On August 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine for individuals older than 16, making it the first COVID-19 vaccine to receive full FDA approval. It will now be marketed as “Comirnaty” alongside other approved vaccines and drugs. While Pfizer and other COVID-19 manufacturers have met the FDA’s standards for Emergency Use Authorization (EUA), full FDA approval means the vaccine has undergone the agency’s standard process for reviewing its quality, safety and effectiveness.
The FDA issues EUAs during public health emergencies to provide access to medical products, such as vaccines, that are effective at preventing or treating a disease. Both Pfizer and Moderna were issued an EUA in December 2020, while Johnson & Johnson received one in February 2021. Additionally, as the FDA receives more data, it can amend its EUAs, just as it did in extending the Pfizer EUA to include children aged 12-15 and authorizing an additional dose of the Pfizer and Moderna vaccines for certain immunocompromised individuals.
Children between the ages of 12 and 15 are eligible to receive the Pfizer vaccine under an EUA while children under 12 are still ineligible to receive any COVID-19 vaccine. Additional research and clinical trials for children under 12 are ongoing, with early estimates for an EUA to be announced late this fall or early winter. Although Pfizer is the currently the only COVID-19 vaccine manufacturer to receive full approval, Moderna completed their application on August 25 for its vaccine while Johnson & Johnson announced its plan to submit later this year. Vaccine clinics will still administer both the Moderna and Johnson & Johnson vaccine to individuals older than 16, as both manufacturers received an EUA earlier this year.
Following the FDA’s full approval of the Pfizer COVID-19 vaccine, President Biden called on companies to require employees be vaccinated. While many universities and private organizations had already announced vaccine requirements for in-person attendance, several more private and public organizations, as well as some local governments, announced new mandates after Pfizer received full FDA approval.
Full FDA approval may lead to an increase of COVID-19 vaccinations in eligible individuals, an effort that is often spearheaded by local health departments. Counties have been on the front lines of our nation’s response to the coronavirus pandemic and play an essential role in administering COVID-19 vaccines. As of June 29, counties have assisted in the administration of more than 325 million COVID-19 vaccine doses.
Additional Resources
- NACo Brief: The County Role in Vaccines
- FDA Report: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
- CDC Report: Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitals Among Adults
On August 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine for individuals older than 16, making it the first COVID-19 vaccine to receive full FDA approval.2021-08-26Blog2021-09-09
On August 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine for individuals older than 16, making it the first COVID-19 vaccine to receive full FDA approval. It will now be marketed as “Comirnaty” alongside other approved vaccines and drugs. While Pfizer and other COVID-19 manufacturers have met the FDA’s standards for Emergency Use Authorization (EUA), full FDA approval means the vaccine has undergone the agency’s standard process for reviewing its quality, safety and effectiveness.
The FDA issues EUAs during public health emergencies to provide access to medical products, such as vaccines, that are effective at preventing or treating a disease. Both Pfizer and Moderna were issued an EUA in December 2020, while Johnson & Johnson received one in February 2021. Additionally, as the FDA receives more data, it can amend its EUAs, just as it did in extending the Pfizer EUA to include children aged 12-15 and authorizing an additional dose of the Pfizer and Moderna vaccines for certain immunocompromised individuals.
Children between the ages of 12 and 15 are eligible to receive the Pfizer vaccine under an EUA while children under 12 are still ineligible to receive any COVID-19 vaccine. Additional research and clinical trials for children under 12 are ongoing, with early estimates for an EUA to be announced late this fall or early winter. Although Pfizer is the currently the only COVID-19 vaccine manufacturer to receive full approval, Moderna completed their application on August 25 for its vaccine while Johnson & Johnson announced its plan to submit later this year. Vaccine clinics will still administer both the Moderna and Johnson & Johnson vaccine to individuals older than 16, as both manufacturers received an EUA earlier this year.
Following the FDA’s full approval of the Pfizer COVID-19 vaccine, President Biden called on companies to require employees be vaccinated. While many universities and private organizations had already announced vaccine requirements for in-person attendance, several more private and public organizations, as well as some local governments, announced new mandates after Pfizer received full FDA approval.
Full FDA approval may lead to an increase of COVID-19 vaccinations in eligible individuals, an effort that is often spearheaded by local health departments. Counties have been on the front lines of our nation’s response to the coronavirus pandemic and play an essential role in administering COVID-19 vaccines. As of June 29, counties have assisted in the administration of more than 325 million COVID-19 vaccine doses.
Additional Resources
- NACo Brief: The County Role in Vaccines
- FDA Report: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
- CDC Report: Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitals Among Adults

About Blaire Bryant (Full Bio)
Legislative Director – Health | Large Urban County Caucus
More from Blaire Bryant
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Webinar
County Listening Session for the White House Conference on Hunger, Nutrition and Health
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Congress clears bipartisan gun reform legislation
On June 25, Congress passed and the President signed into law the Bipartisan Safer Communities Act (P.L. 117-159), the first major gun reform legislation in decades. The bill makes critical changes to the process for acquiring a firearm and includes funding opportunities to assist in identifying and addressing mental health, and makes key investments in strengthening school safety. -
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CDC announces $4 billion in funding for public health workforce, infrastructure and data systems
On June 23, the Centers for Disease Control and Prevention (CDC) announced Strengthening U.S. Public Health Infrastructure, Workforce, and Data Systems, a new, flexible funding opportunity that will provide nearly $4 billion over five years to improve critical public health infrastructure to health departments across the country. -
Webinar
Protecting Public Health: Vector Disease Management and Mosquito Emergency Response
Jun. 21, 2022 , 1:00 pm – 2:00 pmCounty leaders are working across different sectors to coordinate programs and services that impact the well-being of communities, especially when it comes to the strong connection between the environment and public health. -
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CDC approves COVID-19 vaccine for children under 5
On June 18, the U.S. Centers for Disease Control and Prevention (CDC) approved the use of COVID-19 vaccines for children aged 6 months to 5 years old, following a recommendation from the Food and Drug Administration (FDA). -
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Tell your county’s story by completing Medicaid and SNAP surveys
To better inform our understanding of the county role in administering Medicaid services and how counties can strengthen coordination between the Medicaid and the Supplemental Nutrition Assistance Program (SNAP), the National Association of Counties (NACo) invites county health and human services officials to complete two research surveys.
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The Stepping Up Initiative
In May 2015, NACo and partners at the CSG Justice Center and APA Foundation launched Stepping Up: A National Initiative to Reduce the Number of People with Mental Illnesses in Jails.pagepagepage<h2>Overview</h2>
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COVID-19 Recovery Clearinghouse
The COVID-19 Recovery Clearinghouse features timely resources for counties, including allocation estimations, examples of county programs using federal coronavirus relief funds, the latest news and more.Reports & Toolkitsdocument03127:15 pmReports & Toolkits<table border="1" cellpadding="1" cellspacing="1" style="width:100%" summary="ad-block no-top-margin no-bullets">
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State and Local Fiscal Recovery Fund Resource Hub
Explore NACo's resource hub for the ARPA State and Local Fiscal Recovery Fund.Reports & Toolkitsdocument010512:15 pmReports & Toolkits<table border="1" cellpadding="1" cellspacing="1" style="width:100%" summary="call-out transparent">
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Live Healthy U.S. Counties
The National Association of Counties (NACo) Live Healthy Prescription, Health & Dental Discount Program is a NO-COST program available to all member counties.pagepagepage<h1>With <a id="naco" name="naco">NACo</a>, Saving Feels Better</h1>
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Implementing Infrastructure Investments at the County Level: The Bipartisan Infrastructure Law (P.L. 117-58)
On November 15, 2021, President Biden enacted the Bipartisan Infrastructure Law (BIL), formally known as the Infrastructure Investment and Jobs Act (P.L. 117-58), into law. This page and its contents are supplemental to NACo's comprehensive legislative analysis of the BIL for counties.Reports & Toolkitsdocument030310:00 amReports & Toolkits<table border="1" cellpadding="1" cellspacing="1" style="width:100%" summary="call-out transparent jump">
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Contact
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Legislative Director – Health | Large Urban County Caucus(202) 942-4246
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The Local Government ARPA Investment Tracker, powered by NACo, Brookings Metro and National League of Cities provides a detailed local investment picture of American Rescue Plan Act funding.
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