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
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9:25 p.m. ET, August 23, 2021

Pfizer is making a vaccine targeting the Delta variant, but it may not be necessary, company CEO says

From CNN's Lauren Mascarenhas

Pfizer is making a vaccine specifically targeting the Delta variant, but the company's CEO Albert Bourla said Monday he doesn’t think it will be needed because the current vaccine is so effective.

“We are making right now a specialized vaccine for Delta,” Bourla told NBC Nightly News. “I'm almost certain that we will not need it.”

That’s because Pfizer’s current Covid-19 vaccine is already working well against the variant, he noted. 

“The current vaccine is very, very, very effective against Delta, but we cannot take that chance,” Bourla said.
7:28 p.m. ET, August 23, 2021

Here's the latest on vaccination efforts in the US

From CNN's Deidre McPhillips

Michigan is the latest state to fully vaccinate at least half of its residents against Covid-19, according to data published Monday by the US Centers for Disease Control and Prevention.

Here’s latest CDC data on vaccination efforts in the US:

  • Fully vaccinated: 51.5% of the total US population
  • Not vaccinated: 28.9% of the eligible population (ages 12 and older)
  • Current pace of vaccinations (seven-day average): 446,177 people are initiating vaccination each day.
  • The daily pace has been steadily above 400,000 new vaccinations each day throughout August.
  • An average of 853,676 doses are being administered each day.
  • 25 states have fully vaccinated more than half of their residents: California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin, as well as Washington, DC.
  • Michigan is the latest state to reach this threshold.
  • Vermont leads the nation with 67.5% of residents full vaccinated, while Alabama trails with 36.6% of residents fully vaccinated. 
8:42 p.m. ET, August 23, 2021

Fauci says US could have control over Covid-19 entering spring of 2022 if everyone gets vaccinated

From CNN's Lauren Mascarenhas

If most eligible people get vaccinated, the US could have control over Covid-19 entering the Spring of 2022, Dr. Anthony Fauci said Monday.

Fauci said he misspoke earlier in the day, when he told NPR it would be the fall of 2022.

“If we can get through this winter and get really the majority – overwhelming majority – of the 90 million people who have not been vaccinated, vaccinated, I hope we can start to get some good control in the spring of 2022,” Fauci told CNN’s Anderson Cooper.

Fauci said that includes vaccinating people who have contracted and recovered from Covid-19, who could stand to gain “an enormous increase in the degree of protection” from the vaccine. 

“As we get into the spring, we could start getting back to a degree of normality, namely reassuming the things that we were hoping we could do – restaurants, theaters, that kind of thing,” he said.

Fauci, director of the National Institute of Allergy and Infectious Diseases, noted that the spring 2022 timeframe is a hope, but not a guarantee.

“It's up to us,” he said. “If we keep lingering without getting those people vaccinated that should be vaccinated, this thing could linger on, leading to the development of another variant, which could complicate things.”

Fauci said it’s not yet clear what percentage of the population needs to be vaccinated for the US to gain control over the virus.

“You know how you're going to know? Just get as many people vaccinated as you possibly can, and when you get control, that'll be the number,” Fauci said.

Update: This story has been updated to include Fauci's latest remarks to CNN on when he hopes the US could get control of Covid-19 if everyone gets vaccinated. He said he hopes it could happen in the spring of 2022. Earlier, Fauci told NPR it would be the fall of 2022.

6:02 p.m. ET, August 23, 2021

Covid-19 vaccines now required for all University of Minnesota students after FDA approval of Pfizer vaccine

From CNN’s Jennifer Henderson and Kara Devlin

Ken Wolter/Shutterstock
Ken Wolter/Shutterstock

The University of Michigan is requiring all enrolled students to be vaccinated for Covid-19 now that the Pfizer Covid-19 vaccine was approved by the US Food and Drug Administration, University President Joan Gabel and Jakub Tolar, the dean of the medical school, announced in a letter to students, faculty and staff on Monday.

In earlier communications from the university, students were told once the Covid-19 vaccine had been approved by the FDA, it would be required, the letter states.

Faculty and staff will be “expected” to attest to their vaccination status starting Tuesday, the letter adds.

4:05 p.m. ET, August 23, 2021

White House indicates there will be more Covid-19 vaccine mandates for factions of federal workforce

From CNN's Maegan Vazquez

White House press secretary Jen Psaki indicated on Monday that the Biden administration expects to roll out more Covid-19 vaccine mandates within the federal government following the FDA’s recent approval of the Pfizer-BioNTech Covid-19 vaccine.

Asked if the full approval announcement will lead to any additional vaccine mandates from the Biden administration beyond what has been announced, Psaki said during the press briefing, “I expect there will be more, sure, as we’ve said all along.”

“And I would note that my colleagues at the Department of Defense conveyed that they would move in the coming days to mandate the vaccine now that the approval has come from the FDA for Pfizer. So we certainly expect there will be more mandates for factions of federal employees,” she continued.

In a follow-up question about whether the President will expand its federal vaccine requirement and mandate it so there’s no longer an opt-out option, Psaki said, “I think you’re looking more at agency-to-agency or different factions of the government at this point. But I expect there will be more on that front.”

Some more background: Last month, Biden announced all federal employees must attest to being vaccinated against Covid-19 or face strict protocols including regular testing, masking, limits on official travel and other mitigation measures.

Contractors working for the federal government will also be subject to the new rules.

Pentagon press secretary John Kirby said during a Pentagon briefing on Monday the Department of Defense would move forward with requiring all US military service members to be vaccinated now that the Pfizer/BioNTech vaccine has full FDA approval.

CNN's Kate Sullivan contributed reporting to this post. 

2:33 p.m. ET, August 23, 2021

More than 600 Nashville public school students tested positive for Covid-19 in the first 2 weeks of class

From CNN's Mallory Simon

Nashville, Tennessee, public schools reported 395 students and 67 teachers tested positive for Covid-19 in the last week, according to the district’s Covid-19 dashboard.  

The rising case count comes after 207 students and 52 employees tested positive in the first four days school was open within the district. 

In addition, 2,879 students and 143 employees were quarantined or in isolation from August 16 through August 22, according to the Metro Nashville Public Schools Covid-19 dashboard.

Since Aug. 10 when most Nashville schools opened, at least 3,859 students and 238 employees have had to quarantine. 

A total of 602 students have tested positive for Covid-19 in the first two weeks of school, according to the Metro Nashville Public Schools Covid-19 dashboard. 

In the same time period, 119 employees have tested positive for Covid-19 with 67 of them coming in the last week, according to the data. 

Before school began, the Metro Nashville Board of Education voted to introduce a mask mandate for all 80,000 students in the district as well as all teachers. It is not clear whether the virus spread in school, and the case total likely reflects spread within the community before in-person instruction began.

2:19 p.m. ET, August 23, 2021

Here is what Biden says parents should do to keep kids safe from Covid-19

(Jim Watson/AFP/Getty Images)
(Jim Watson/AFP/Getty Images)

President Biden spoke today addressing concerns about Covid-19 cases among children. He said that cases among children are "still rare, and severe cases among children are very, very rare." 

He said that it's "not as reassuring as anyone would like it to be" for parents who are concerned about their children and Covid-19. Biden said that parents have "two tools" available to keep their kids safe.

"One, make sure that everyone around your child who can be vaccinated is vaccinated. Parents, adults, teens. Two, make sure your child is masked when they leave home. That's how we can best keep our kids safe," the President said.

2:16 p.m. ET, August 23, 2021

Biden: FDA approval of the Pfizer Covid-19 vaccine is important "in our fight against the pandemic"

From CNN's Maureen Chowdhury

(Jim Watson/AFP/Getty Images)
(Jim Watson/AFP/Getty Images)

President Biden said the US Food and Drug Administration's (FDA) approval of the Pfizer vaccine is "an important moment in our fight against the pandemic."

During remarks from the White House, Biden urged those who were hesitant to receive a vaccine until FDA approval to do so now.

"So, let me say this loudly and clearly ... If you are one of the millions of Americans who have said that they will not get the shot until it has full and final approval of the FDA, it is now happened. The moment you've been waiting for is here. It's time for you to go get your vaccination and get it today," Biden said.

Biden added, "The FDA approval is the gold standard. And as I just said, now it has been granted. Those who have been waiting for full approval should go get your shot now. The vaccination is free, it's easy, it's safe, and it's effective, and it's convenient."

1:58 p.m. ET, August 23, 2021

NOW: Biden speaks after FDA approves Pfizer's Covid-19 vaccine

From CNN's Kate Sullivan

President Biden is speaking from the White House following the US Food and Drug Administration's full approval of the Pfizer-BioNTech's Covid-19 vaccine.

According to a White House official, Biden will encourage Americans who have been waiting for the vaccine's full approval to go get vaccinated against Covid-19 and he'll also reiterate his call for private and public sector leaders to adopt strong vaccination requirements.

The Pfizer/BioNTech Covid-19 vaccine is the first coronavirus vaccine to be fully approved by the FDA — the Moderna and Johnson & Johnson Covid-19 vaccines remain under emergency use authorization — and the announcement is expected to open the door to more vaccine mandates.

Last month, Biden announced all federal employees must attest to being vaccinated against Covid-19 or face strict protocols including regular testing, masking, limits on official travel and other mitigation measures. Contractors working for the federal government will also be subject to the new rules.

Read more about Biden's remarks here.