The latest on the Covid-19 pandemic in the US

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.

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.”

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.

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.

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.

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.

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.

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

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.

A funeral home worker transports the body of woman who died of Covid-19 at her home in Houston, Texas, on September 13.

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.

A nurse fills a syringe with a dose of the Pfizer/BioNTech vaccine on September 14 in Reading, Pennsylvania.

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:

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.

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.

Vials of the Pfizer Covid-19 vaccine are seen at a vaccination clinic in Winter Springs, Florida, on September 11.

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. 

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.

If the Pfizer/BioNTech Covid-19 vaccine is authorized for children ages five to 11, more than 28 million additional people will be eligible to be vaccinated against Covid-19, according to a CNN analysis of data from the US Census Bureau.  

Currently, about 85% of the US population is eligible to receive a Covid-19 vaccine. But the five to 11 age group represents about 9% of the total United States population, which would bump it up to 94%.

According to the latest data from the US Centers for Disease Control and Prevention, 63.8% of the total US population has received at least one dose of Covid-19 vaccine and 54.6% of the population is fully vaccinated. 

But adolescents are the least vaccinated group. About 57% of adolescents age 12 to 17 have received at least one dose and 46% are fully vaccinated, according to a CNN analysis of CDC data. Children 16 and up were included in the initial emergency use authorization of the Pfizer/BioNTech vaccine and children ages 12 to 15 were added in May, more than four months ago.  

Covid-19 cases among children have increased 240% since July and recently hit a record high, according to the American Academy of Pediatrics. As of Sept. 9, nearly 5.3 million children have tested positive for Covid-19. 

In a news release Monday, Pfizer said that trial data shows that its Covid-19 vaccine for children ages 5 to 11 is safe and generated a “robust” antibody response. They plan to submit to the US Food and Drug Administration for emergency use authorization soon.