US FDA approves first Covid-19 vaccine

By Melissa Macaya, Mike Hayes, Meg Wagner and Veronica Rocha, CNN

Updated 11:16 PM ET, Mon August 23, 2021
16 Posts
Sort byDropdown arrow
1:30 p.m. ET, August 23, 2021

United Airlines workers required to get vaccinated sooner following FDA approval of Pfizer Covid-19 vaccine

From CNN's Pete Muntean

A pilot walks by United Airlines planes as they sit parked at gates at San Francisco International Airport in April 2020.
A pilot walks by United Airlines planes as they sit parked at gates at San Francisco International Airport in April 2020. Justin Sullivan/Getty Images

The deadline for United Airlines employees to get vaccinated or lose their job has been bumped up now that the Pfizer/BioNTech vaccine has been granted full FDA approval. 

United Airlines confirmed on Monday that all of its 67,000 employees in the US will need to be fully vaccinated by Sept. 27 or face getting fired. 

United’s mandate originally spelled out that workers must get vaccinated by Oct. 25 or five weeks from FDA approval of any vaccine, whichever came first. 

The carrier is the only major US airline to mandate its workers get vaccinated.

Following United’s announcement earlier this month, CEOs of Southwest Airlines, Delta Air Lines and American Airlines all said that they were not changing their policies and insisted that many of their employees were already vaccinated even without a mandate. Alaska Airlines said it was considering an employee mandate if a vaccine became fully FDA approved.

1:04 p.m. ET, August 23, 2021

Vaccine mandate for New York City education employees will go into effect on Sept. 27, mayor says

From CNN’s Artemis Moshtaghian

A teacher at Yung Wing School in New York, goes over a lesson on a monitor with in-person Summer program students on July 22, 2021 in New York City. Positive COVID-19 cases in some New York City public schools have resulted in classroom quarantines. (Photo by Michael Loccisano/Getty Images)
A teacher at Yung Wing School in New York, goes over a lesson on a monitor with in-person Summer program students on July 22, 2021 in New York City. Positive COVID-19 cases in some New York City public schools have resulted in classroom quarantines. (Photo by Michael Loccisano/Getty Images)

New York City Mayor Bill de Blasio said today that the "mandate" for all NYC Department of Education employees to get the Covid-19 vaccine "will take place on September 27."

Starting this week, de Blasio’s administration will begin bargaining with labor unions over the specific impacts of the new vaccine mandate and will be working with the unions to determine elements of implementation.

“Either way you slice it though, this policy is moving forward and this mandate will be in place—that’s the bottom line," the mayor said.

The mayor noted that he’s not worried about teacher resignations stemming from the vaccine mandate, saying he feels "confident that this is going to work, we're going to see a lot of our teachers and other school staff get vaccinated as a result of this mandate."

The mayor also said he’s not concerned about teacher shortages because “a lot of teachers and other professionals yearn to work in the NYC public school system for a lot of reasons, including the way we compensate.”

New York City Department of Education Chancellor Meisha Porter chimed in support of the mayor’s sentiments, saying that city's public school system teachers have showed throughout the pandemic. “This is next way to get our babies back in class and to keep them protected and safe," she said.

De Blasio added that he’s looking forward to getting authorization approved to be able vaccinate children between the ages of 5 and 11 as soon as a few months from now.

“We're seeing a great response from our young people and our parents,” he said, adding that his administration is currently focused on vaccinating NYC children ages 12 and up over the next weeks.

There are currently no Covid-19 vaccines authorized for individuals under the age of 12. Pfizer has said it expects to have vaccine trial data on children ages 5 to 11 by the end of September, and the company could apply to have its vaccine authorized for those younger ages shortly after. The company also has said data for even younger children, ages 2 to 5, could be available shortly after.

Moderna and Johnson & Johnson are also working on studies in children.

CNN's Jacqueline Howard contributed reporting to this post.

12:27 p.m. ET, August 23, 2021

Biden will encourage Americans who have been waiting for full FDA approval to get the shot today

From CNN's Kate Sullivan 

President-elect Joe Biden receives his second dose of the Pfizer Covid-19 vaccine on January 11 in Newark, Delaware.
President-elect Joe Biden receives his second dose of the Pfizer Covid-19 vaccine on January 11 in Newark, Delaware. Alex Wong/Getty Images

President Biden on Monday will encourage Americans who have been waiting for full approval from the US Food and Drug Administration to go get vaccinated against Covid-19 today, a White House official tells CNN. 

The President will mark the key milestone of Pfizer/BioNTech’s Covid-19 vaccine receiving full FDA approval in remarks on Monday afternoon at the White House, and will reiterate his call for private and public sector leaders to adopt strong vaccination requirements, the official said.  

“President Biden will deliver remarks to highlight the vaccination progress we have made in seven months, including over 170 million fully vaccinated Americans, and acknowledge another key milestone in our fight against the virus — FDA’s full approval of the Pfizer vaccine,” the official told CNN.

“The President will encourage Americans who have been waiting for full FDA approval to join the more than 200 million Americans who have already gotten a shot and go get vaccinated today, and he will reiterate his call to action to private and public sector leaders to adopt strong vaccination requirements," the official added.
11:52 a.m. ET, August 23, 2021

FDA completed Pfizer vaccine full approval in about 40% of the time it would normally take, official says

From CNN's Jacqueline Howard

To issue full licensure to the Pfizer/BioNTech Covid-19 vaccine, the US Food and Drug Administration worked around the clock and conducted its own analyses of the vaccine in addition to the companies' analyses, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a briefing call on Monday.

The FDA completed the full approval process "in about 40%" of the time it would normally take for an approval application submission of this magnitude, Marks said. 

"We also did benefit-risk assessments based on real-world data that has emerged since the vaccine has now been used in hundreds of millions of people globally. And so that actually takes a lot of work," Marks said, adding that the agency also inspected facilities that make the product.

"It's actually 97 days since Pfizer completed the role of its BLA and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude," Marks added. "So, there was a lot of work done and people worked day and night."
11:36 a.m. ET, August 23, 2021

Approval of Pfizer's vaccine does not mean it can be used off-label in younger kids, FDA says

From CNN's Jacqueline Howard

Even though the US Food and Drug Administration approved the Pfizer/BioNtech Covid-19 vaccine on Monday for people 16 and older, the agency emphasizes that this does not mean the vaccine can be used "off-label" in children younger than 12, saying it “it would not be appropriate.”

Off-label refers to an approved product being used in a way or in a patient that it wasn't necessarily approved for. The Pfizer/BioNTech Covid-19 vaccine is still available to people as young as 12 under emergency use authorization or EUA, but it is not currently approved nor authorized for children younger than 12.

"We want to reiterate, it is important that the unvaccinated get vaccinated where it is indicated, but we do not have data on the proper dose nor do we have full data on the safety in children younger than what is in the EUA," Acting FDA Commissioner Dr. Janet Woodcock said during a briefing call on Monday.

"So that would be a great concern that people would vaccinate children because we don't have the proper dose and we don't have the safety data, nor do we have all the efficacy data, as well," Woodcock said. "We are not recommending that children younger than age 12 be vaccinated with this vaccine. It would not be appropriate."

8:10 p.m. ET, August 23, 2021

Pfizer's vaccine approval means "public can be confident" it meets FDA standards, acting commissioner says

From CNN's Jacqueline Howard

A pharmacist prepares a dose of the Pfizer COVID-19 vaccine at a clinic operated by DePaul Community Health Center on August 12, 2021 in New Orleans, Louisiana. 
A pharmacist prepares a dose of the Pfizer COVID-19 vaccine at a clinic operated by DePaul Community Health Center on August 12, 2021 in New Orleans, Louisiana.  Mario Tama/Getty Images

The US Food and Drug Administration's full approval of the Pfizer/BioNTech Covid-19 vaccine on Monday means that the American public can be "confident" in the vaccine, Acting FDA Commissioner Dr. Janet Woodcock said during a briefing call on Monday.

"While this and other vaccines have met the FDA's rigorous scientific standards for emergency use authorization, as the first FDA approved Covid-19 vaccine, the public can be confident that this vaccine meets the FDA's gold standard for safety, effectiveness and manufacturing quality that we require for an approved product," Woodcock said on Monday. 

Woodcock called the approval "a pivotal moment" for the United States' fight against the coronavirus pandemic.

"Health care providers can continue to use the vaccine on their shelves," Woodcock added. "The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably to provide the Covid-19 vaccine series."

11:42 a.m. ET, August 23, 2021

Pentagon: US military will make Covid-19 vaccines mandatory following FDA approval of Pfizer's shot

Pentagon press secretary John Kirby said that the US military will now require all service members to be vaccinated from Covid-19 following the FDA approval of the Pfizer vaccine.

Speaking at a press conference this morning, Kirby said that the Department of Defense is "prepared to issue updated guidance requiring all service members to be vaccinated," adding that a "timeline for vaccination completion will be provided in the coming days" by DOD.

"We're going to move forward, making that vaccine mandatory. We're preparing the guidance to the force right now. And the actual completion date of it, in other words, how fast we want to see it get done, we're working through that guidance right now."

Some context: Previously, US Defense Secretary Lloyd Austin said that it was his intent to mandate the Covid-19 vaccine for the military upon FDA licensure or by mid-September to seek a waiver from the President. 

11:13 a.m. ET, August 23, 2021

New York City mayor announces Covid-19 vaccine mandate for all education department employees

From CNN’s Artemis Moshtaghian

NYC Media
NYC Media

New York City Mayor Bill de Blasio announced a Covid-19 vaccine mandate for all education department staff on Monday for all public schools across the city without a testing alternative, becoming the largest school system in the US to do so.

All school staff are required to provide proof of vaccination of at least one dose of the Covid-19 vaccine by Sept. 27, the mayor said.

The New York City Department of Education (DOE) now becomes the largest public school system in the US to mandate Covid-19 vaccines for its employees.

The NYC DOE serves 1.1 million students in over 1,800 schools and employs at least 143,000 people within the education system.

10:52 a.m. ET, August 23, 2021

Pfizer working on plans to market and advertise its newly approved Covid-19 vaccine

From CNN’s Amanda Sealy

A pharmacy technician loads a syringe with Pfizer's COVID-19 vaccine, Tuesday, March 2, 2021 at a mass vaccination site at the Portland Expo in Portland, Maine. 
A pharmacy technician loads a syringe with Pfizer's COVID-19 vaccine, Tuesday, March 2, 2021 at a mass vaccination site at the Portland Expo in Portland, Maine.  Robert F. Bukaty/AP

Now that the Pfizer/BioNTech Covid-19 vaccine has received full approval from the US Food and Drug Administration, the companies are able to market and advertise the vaccine.

A spokesperson for Pfizer told CNN Monday that the company hopes to increase confidence in the Covid-19 vaccines.

They also said the company plans to market and advertise its vaccine under the brand name Comirnaty.