The latest on the Covid-19 pandemic in the US

By Melissa Macaya, Melissa Mahtani, Mike Hayes and Meg Wagner, CNN

Updated 7:55 p.m. ET, September 20, 2021
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7:30 p.m. ET, September 20, 2021

FDA may expand any Covid-19 vaccine booster decisions, Fauci says

From CNN's Lauren Mascarenhas

The US Food and Drug Administration is likely to expand any authorizations it may give for Covid-19 vaccine booster recommendation if new data supports wider use, Dr. Anthony Fauci said Monday.

FDA vaccine advisers voted Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine for people 65 and older and those at high risk of severe Covid-19. The FDA has yet to act on that recommendation.

But Fauci told CNN’s Wolf Blitzer that the FDA will be following incoming data from the US and Israel in real time and will adjust any authorizations accordingly.

“The waning of protection, particularly against severe disease in younger groups, would trigger the FDA to look at that and see if they want to expand the recommendation to go much younger than 65,” Fauci said.

Fauci said that people will be carefully considering the risk of myocarditis, a rare heart complication associated with the vaccine, seen particularly in young men. 

“When you get down to the younger group, particularly young men, where the potential for the rare adverse effect of myocarditis exists, then it'll be very important to get good safety data in younger people, particularly men,” Fauci said.

If that data does come in, “then I think it's likely, as we go on over the coming weeks, we'll see more and more of an expansion of the recommendation for the boosters for those individuals,” Fauci said.

Those who received the Moderna or one-dose Johnson & Johnson vaccine for their initial vaccine “have not been forgotten,” Fauci, director of the National Institute of Allergy and Infectious Diseases, noted.

“The data associated with the boosters in those individuals will be coming to the FDA, I would imagine in a couple to three weeks,” he said. “They will examine it in the same way as they did before, and hopefully, they will get a recommendation that would provide equity among people who have had different products in their vaccination regimen.”

 

6:56 p.m. ET, September 20, 2021

FDA decision on Pfizer Covid-19 vaccine for kids ages 5 to 11 could come in "a matter of weeks," Fauci says

From CNN's Lauren Mascarenhas

The US Food and Drug Administration could make a decision on Pfizer’s Covid-19 vaccine for kids ages 5 to 11 in “a matter of weeks,” Dr. Anthony Fauci said Monday.

Pfizer announced Monday that clinical trials of its two-dose vaccine for children ages 5 to 11 showed it is safe and generated a robust antibody response. Fauci, director of the National Institute of Allergy and Infectious Diseases, said that data will be presented to the FDA, which will work quickly to make a determination about the vaccine for children.

“I would imagine we're talking at a matter of weeks, possibly by the end of the month, beginning of next month,” Fauci told CNN’s Wolf Blitzer.

When asked whether people should be skeptical of Pfizer’s findings because the company has yet to publicly release the data, Fauci said, “No. Not at all.”

“I have confidence that if they feel that they are going to present that to the FDA for an EUA approval, I doubt very seriously that there's anything to be concerned about in that data,” he added. 

The Pfizer vaccine for children aged 5 to 11 contains a third of the dose given to people 12 and older. Fauci said that basing the “cutoff point” on age – rather than weight, for example – was logistically feasible.

“I don't think there's anything wrong with that, and parents should not be confused or concerned about that,” he said.

5:26 p.m. ET, September 20, 2021

Nearly 226,000 children reported with Covid-19 last week, pediatrician group says

From CNN's Jen Christensen

Coronavirus infections have continued to increase “exponentially” among children across the US, and now account for nearly 26% of all cases reported nationwide, new data published Monday shows.

The American Academy of Pediatrics report 225,978 new cases among kids over the past week, a slight decline from the week before when 243,373 new cases were reported. That had been the second highest total of new diagnoses among children reported during the pandemic.

“After declining in early summer, child cases have increased exponentially, with over 925,000 cases in the past four weeks,” the group said in a statement.

The weekly case number reported Monday is about a 215% increase in cases among children since the week of July 22-29 when the group counted 71,726 cases.

As of Sept. 16, more than 5.5 million kids have tested positive for Covid-19. 

Still, children are far less likely than adults to suffer serious disease or to die from Covid-19. Among states that report hospitalizations by age, children make up between 1.6% and 4.2% of patients hospitalized for Covid-19.

Among the states that report death by age, children accounted for no more than 0.25% of the deaths. Seven states have reported no pediatric deaths. As of Sunday, the US Centers for Disease Control and Prevention reported 548 children younger than 18 had died for Covid-19 in the United States.

Pre-teens and teens have the lowest Covid-19 vaccination rates of any age group. Vaccines are not yet approved or authorized for children under 12.

5:02 p.m. ET, September 20, 2021

There are still 4 steps that must happen before younger children receive Covid-19 vaccines

From CNN's Jacqueline Howard

After Pfizer and BioNTech announced that a Phase 2/3 trial of their Covid-19 vaccine was found to be safe and generated a “robust” antibody response in children ages 5 to 11, there are still several steps before vaccines will be available for that age group.

First: Pfizer needs to ask the US Food and Drug Administration for the emergency use authorization (EUA) of its Covid-19 vaccine to include children ages 5 to 11.

"The company needs to submit a request to amend its EUA to include the additional population," an FDA spokesperson told CNN in an email on Monday. 

Dr. Scott Gottlieb, former commissioner of the FDA and a board member at Pfizer, said on CNBC's Squawk Box on Monday morning that Pfizer could file to the FDA "very quickly,” and then FDA’s process would begin.

"The data came a little earlier than some were expecting, and depending on how long the FDA takes to review the application, whether it's a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October, perhaps it slips a little bit into November," Gottlieb said.

Second: The EUA for Pfizer’s vaccine for people ages 12 to 15 needs to be extended to include younger ages.  

"When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months," Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a previous statement earlier this month about vaccines for young children.
“However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers,” Woodcock and Marks said. “Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners.”   

The FDA’s Vaccines and Related Biological Products Advisory Committee likely will meet to discuss Pfizer and BioNTech’s data. In that meeting, committee members could vote on whether they recommend the EUA be amended to include children ages 5 to 11.

"Once we see a timeline for that actual meeting occurring, that will give us a good idea of when we might potentially see approval," Dr. Evan Anderson, a physician at Children’s Healthcare of Atlanta and a professor of pediatrics and medicine at Emory University, said during a call with reporters Monday. "That meeting of advisers will then need to occur. FDA would then need to either agree with or disagree with their external group of advisers about potential approval."

Third: The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices needs to recommend the shots.

If the vaccine is authorized by the FDA, the CDC’s vaccine advisers will evaluate vaccine data to decide whether it should be recommended for ages 5 to 11.

"That has typically occurred within a couple days of FDA approval, and I think that that would likely occur here again," Anderson said. 

The CDC director generally accepts ACIP’s recommendation shortly after, which makes the recommendation official.

Fourth: Once the FDA and CDC sign off, a rollout of vaccines for children ages 5 to 11 could start.

Although many adults got their shots through nursing homes or mass vaccination sites early on, the rollout looked a bit different by the time the youngest children so far – those ages 12 to 15 – were vaccinated.

For those young people, the focus was on pharmacies and doctors’ offices, and that’s likely to be the case with even younger children, too. Some places may begin vaccinating younger children immediately, and some might need to open appointments or increase staffing.

4:40 p.m. ET, September 20, 2021

More than 675,000 people have died of Covid-19 in the US, surpassing country's 1918 flu pandemic death toll

From CNN's Deidre McPhillips

A funeral home worker transports the body of woman who died of Covid-19 at her home in Houston, Texas, on September 13.
A funeral home worker transports the body of woman who died of Covid-19 at her home in Houston, Texas, on September 13. (John Moore/Getty Images)

More than 675,000 people have died of Covid-19 in the United States, surpassing the country’s estimated death toll from the 1918 flu pandemic.

According to the latest figures from Johns Hopkins University, at least 675,446 people have died of Covid-19 in the US. With a total population of about 328 million, that works out to more than 1 death per every 500 people.

An estimated 675,000 people in the US died in the 1918 flu pandemic, according to the US Centers for Disease Control and Prevention. A century ago, the US population was closer to 103 million, which would translate to about 1 flu death per every 150 people in 1918.

Some more context: Globally, about 4.7 million people have died of Covid-19, and the US accounts for about one in seven total Covid-19 deaths, JHU data shows. But during the 1918 flu pandemic, the US accounted for about 1% of the 50 million total deaths worldwide, according to the CDC.

Currently, about 1,926 people are dying of Covid-19 each day in the US, JHU data shows.

More than a third of total Covid-19 deaths in the US occurred between December 2020 and February 2021, according to JHU data.

 

5:29 p.m. ET, September 20, 2021

Pfizer vaccine accounts for 70% of Covid-19 vaccine doses given in US since approved, CDC data shows

From CNN's Deidre McPhillips

A nurse fills a syringe with a dose of the Pfizer/BioNTech vaccine on September 14 in Reading, Pennsylvania.
A nurse fills a syringe with a dose of the Pfizer/BioNTech vaccine on September 14 in Reading, Pennsylvania. (Ben Hasty/MediaNews Group/Reading Eagle/Getty Images)

The Pfizer/BioNTech vaccine is the most frequently administered, and it has become especially predominant in recent months, according to data published Monday by the US Centers for Disease Control and Prevention.

Since the US Food and Drug Administration fully approved the Pfizer/BioNTech vaccine about a month ago, it has accounted for nearly 70% of all vaccine doses administered.

Overall, more than 221 million doses of the Pfizer/BioNTech vaccine have been administered, accounting for about 57% of all doses administered.

Since the FDA authorized the Pfizer/BioNTech vaccine for emergency use in children age 12-15 in May, it has accounted for about 65% of all vaccine doses administered.

Here's some more of the latest data on vaccination efforts in the US:

  • Fully vaccinated: 54.7% of the total US population (all ages), about 182 million people
  • Not vaccinated: 25.3% of the eligible population (12 years and older), about 72 million people
  • Current pace of vaccinations (seven-day average): 333,475 people are initiating vaccination each day.
  • This is about the same last week, but a 30% drop from a month earlier.
  • An average of 772,308 doses are being administered each day.
  • About 2.2 million people have received an additional dose – or booster – since Aug. 13.
  • 30 states have fully vaccinated more than half of their residents: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Vermont, Virginia, Washington and Wisconsin, as well as Washington, DC.

 

11:29 a.m. ET, September 20, 2021

Texas reports more than 20,000 new Covid-19 cases among public school students 

From CNN's Elizabeth Stuart

More than 20,000 new cases of Covid-19 were reported among public school students in Texas, for the week ending Sept. 12, according to data released Friday by the Texas Education Agency. 

At least 23,779 students and 3,851 staff members tested positive for Covid-19, a decline from the previous week, when more than 40,000 students and 5,000 staff members tested positive.

Public schools are required to report positive Covid-19 cases on school campuses. The state's dashboard is updated each Friday with data from the previous week.

Cumulatively, since the dashboard started tracking on Aug. 13, there have been 126,687 students and 24,476 staff members in the state of Texas who have tested positive for Covid-19. Around 5.3 million students are enrolled for public school in Texas as of January 2021.

The three districts with the highest number of student cases from Sept 6 to Sept. 12 were Cypress-Fairbanks, with 699 cases; Conroe ISD, with 665 cases; and Katy ISD, with 500 cases. Masks are optional in all three districts.

 

10:50 a.m. ET, September 20, 2021

US will ease travel restrictions on fully vaccinated visitors from UK and EU, source says

From CNN's Kevin Liptak and Arlette Saenz

The United States plans to ease travel restrictions on visitors from Europe and the United Kingdom starting in November, a person familiar with the matter says.

The United States will require that adult foreign nationals traveling to the United States be fully vaccinated, another source familiar with the matter said, implementing what the source described as strict protocols to prevent the spread of Covid-19 from passengers who are flying internationally to the US.

The White House was preparing to make the announcement later Monday, including additional elements to the plan for international travel.

The lifting of restrictions on travel to the United States will come as welcome news to thousands European citizens with families in the United States who have been kept apart for almost the entire pandemic.

It will also be greeted favorably by the travel industry, which had been lobbying the federal government to lift some of the rules preventing international tourism.

Airlines, hotels and hospitality groups had all voiced support for allowing vaccinated tourists from abroad back into the United States.

Read more about the measures here.

9:33 a.m. ET, September 20, 2021

Pfizer's Covid-19 vaccine for children could be available by end of October, official says 

From CNN’s Naomi Thomas

Vials of the Pfizer Covid-19 vaccine are seen at a vaccination clinic in Winter Springs, Florida, on September 11.
Vials of the Pfizer Covid-19 vaccine are seen at a vaccination clinic in Winter Springs, Florida, on September 11. (Paul Hennessy/SOPA Images/LightRocket via Getty Images)

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration and a board member at Pfizer, said on CNBC’s Squawk Box Monday that a vaccine for children could be available as early as the end of October. 

“Pfizer could be in a position to file very quickly,” Gottlieb said, when asked when the vaccine could be available for children. “The data came a little earlier than some were expecting, and depending on how long the FDA takes to review the application, whether it’s a four week review or a six week review, you could have a vaccine available to children as early as probably by the end of October, perhaps it slips a little bit into November.”

He also added that it is a 10 microgram dose, “so it’s effectively the same vaccine that’s available for adults and children over the age of 12, just in a lower dose.” 

Gottlieb's comments come after Pfizer said on Monday a Phase 2/3 trial showed its Covid-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11.

These are the first such results released for this age group for a US Covid-19 vaccine, and the data has not yet been peer-reviewed or published. Pfizer said it plans to submit to the FDA for emergency use authorization soon.