By: HISTORY.com Editors

2021

FDA fully approves the Pfizer COVID-19 vaccine

POOL/AFP via Getty Images

Published: July 12, 2022Last Updated: August 25, 2025

On August 23, 2021, the Food and Drug Administration (FDA) fully approves the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and older, following a manufacturing review and analysis of the company’s expanded clinical trial, which included approximately 44,000 participants and found the vaccine to be 91 percent effective in preventing COVID-19.

The Pfizer-BioNTech vaccine was the first COVID-19 vaccination to receive full review and approval from the U.S. regulatory agency. (FDA approval for the vaccine’s use in children aged 5 through 11 followed in October 2021.)

Previously, in December 2020, the Pfizer-BioNTech vaccine was granted emergency use authorization by the FDA in response to the public health emergency posed by the coronavirus pandemic. That authorization involved a review of safety data on over 37,000 participants in a randomized, placebo-controlled study.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Dr. Janet Woodcock, the then acting FDA Commissioner. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The FDA’s approval came amidst the spread of the highly contagious COVID-19 delta variant across the country. It also represented a turning point in U.S.’s response to COVID-19, as more private and public entities began instating vaccination requirements to stem the spread of COVID-19. Among those who adopted vaccine mandates for employees in the wake of the Pfizer-BioNTech vaccine’s FDA approval were the Pentagon and the New York City school system.

Timeline

Also on This Day in History

Discover more of the major events, famous births, notable deaths and everything else history-making that happened on August 23rd

1784

North Carolina counties declare themselves breakaway state of Franklin

On August 23, 1784, four counties in western North Carolina declare their independence as the state of Franklin. The counties lay in what would eventually become Tennessee. The previous April, the state of North Carolina had ceded its western land claims between the Appalachian Mountains and the Mississippi River to the United States Congress. The […]

1:24m read

1823

Mountain man Hugh Glass mauled by a grizzly bear

Then his companions left him for dead deep in the wilderness.

1856

Eunice Foote’s research on global warming is presented publicly

On August 23, 1856, Eunice Foote’s work is presented to a meeting of the American Association for the Advancement of Science (AAAS) in Albany, New York. She is the first to articulate the possibility of global warming from carbon dioxide in the atmosphere. Eunice Foot was a scientist, inventor, women’s rights campaigner, wife and mother. Her […]

1:46m read

1861

Confederate spy Rose O’Neal Greenhow is arrested

Allan Pinkerton, head of the new secret service agency of the Federal government, places Confederate spy Rose O’Neal Greenhow under house arrest in Washington, D.C. Greenhow was a wealthy widow living in Washington at the outbreak of the war. She was well connected in the capital and was especially close with Massachusetts Senator Henry Wilson. […]

1:50m read

1914

Battle of Mons

On August 23, 1914, in their first confrontation on European soil since the Battle of Waterloo in 1815, four divisions of the British Expeditionary Force (BEF), commanded by Sir John French, struggle with the German 1st Army over the 60-foot-wide Mons Canal in Belgium, near the French frontier. The Battle of Mons was the last […]

2:22m read

1926

Star of the silent screen Rudolph Valentino dies

The death of silent-screen idol Rudolph Valentino at the age of 31 sends his fans into a hysterical state of mass mourning. In his brief film career, the Italian-born actor established a reputation as the archetypal screen lover. After his death from a ruptured ulcer was announced, dozens of suicide attempts were reported, and the […]

3:10m read

1927

Sacco and Vanzetti executed

Despite demonstrations in support of their innocence, Italian-born anarchists Nicola Sacco and Bartolomeo Vanzetti are executed for the 1920 murders of a shoe company paymaster and his guard.

1:46m read

1939

Germany, Soviet Union sign nonaggression pact

On August 23, 1939, Germany and the Soviet Union sign a nonaggression pact, stunning the world, given their diametrically opposed ideologies. But the dictators were, despite appearances, both playing to their own political needs. After Nazi Germany’s invasion of Czechoslovakia, Britain had to decide to what extent it would intervene should Hitler continue German expansion. […]

2:08m read

1945

Senior U.S. POW is released

On August 23, 1945, Lt. Gen. Jonathan Wainwright, (captured by the Japanese on the island of Corregidor, in the Philippines), is freed by Russian forces from a POW camp in Manchuria, China. When President Franklin Roosevelt transferred Gen. Douglas MacArthur from his command in the Philippines to Australia in March 1942, Maj. Gen. Wainwright, until […]

1:40m read

1945

Marcario García becomes first Mexican national to receive U.S. Medal of Honor

Though he had landed on the beaches of Normandy and been wounded in battle fighting with the U.S. Army, Staff Sergeant Marcario García was not yet a U.S. citizen when President Harry S. Truman awarded him the Medal of Honor on August 23, 1945. García became the first Mexican national to receive the American military’s […]

1947

First Little League World Series champion crowned

On August 23, 1947, the first Little League World Series championship game—the culmination of a three-day tournament in Williamsport, Pennsylvania—features teams from Pennsylvania. Before roughly 2,500 fans, Maynard, a team from Williamsport, defeats Lock Haven, 16-7, to win the title at Original Field. Although it is called the “World Series,” 11 of the 12 teams in […]

1:30m read

1968

Black soldiers stage sit-in at Fort Hood

On the morning of August 23, 1968, a group of Black soldiers at Fort Hood, Texas stage one of the largest acts of civil disobedience ever recorded among members of the United States military. Adopting the nonviolent tactics of the civil rights movement, the soldiers stage a sit-in to protest their impending deployment to Chicago […]

1:58m read

1970

Lou Reed plays his last show with the Velvet Underground

On August 23, 1970, Lou Reed, lead singer and primary songwriter of the pioneering alt-rock band the Velvet Underground play their last gig together at the famous Manhattan rock club Max’s Kansas City. One of the most influential American bands of the late 1960s and early 1970s, the Velvet Underground had an impact on modern […]

1:42m read

1989

Pete Rose gets booted from baseball

On August 23, 1989, as punishment for betting on baseball, Cincinnati Reds manager Pete Rose accepts a settlement that includes a lifetime ban from the game.

2:42m read

1999

New York City reports first cases of West Nile virus

The first cases of an encephalitis outbreak are reported in New York City on August 23, 1999. Seven people die from what turns out to be the first cases of West Nile virus in the United States. A cluster of eight cases of St. Louis encephalitis was diagnosed among patients in the borough of Queens […]

1:38m read

2000

First “Survivor” finale airs

On August 23, 2000, Richard Hatch, a 39-year-old corporate trainer from Rhode Island, wins the season-one finale of the reality television show “Survivor” and takes home the promised $1 million prize. In a four-to-three vote by his fellow contestants, Hatch, who was known for walking around naked on the island in Borneo where the show […]

1:00m read

2006

Austrian teen escapes after eight years in captivity

Natascha Kampusch, an Austrian teenager who was kidnapped at age 10, escapes from her captor, Wolfgang Priklopil, after more than eight years. Shortly after her escape, Priklopil died by suicide. On March 2, 1998, Kampusch was abducted from a street in Vienna while walking to school. One of Austria’s largest missing-person searches followed, during which […]

1:24m read

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Citation Information

Article Title: FDA fully approves the Pfizer COVID-19 vaccine
Author: HISTORY.com Editors
Website Name: History
URL: https://www.history.com/this-day-in-history/august-23/fda-fully-approves-pfizer-covid-19-vaccine

Date Accessed: October 21, 2026
Publisher: A&E Television Networks
Last Updated: August 25, 2025
Original Published Date: July 12, 2022

FDA fully approves the Pfizer COVID-19 vaccine

Related

21st Century

They Were Inside the Twin Towers on 9/11. Here Are Their Stories.

9/11: How Air Traffic Controllers Managed the Crisis in the Skies

How United Flight 93 Passengers Fought Back on 9/11

About the author

Fact Check

Citation Information