COVID-19 live updates: FDA approval for kids’ vaccines may take longer, source says

(NEW YORK) — The United States has been facing a COVID-19 surge as the more contagious delta variant continues to spread.

More than 690,000 Americans have died from COVID-19 while over 4.7 million people have died from the disease worldwide, according to real-time data compiled by the Center for Systems Science and Engineering at Johns Hopkins University.

Just 64.8% of Americans ages 12 and up are fully vaccinated against COVID-19, according to data from the CDC.

Here’s how the news is developing. All times Eastern:

Sep 28, 7:29 pm
FDA approval for kids’ vaccinations could take longer: Source

The Food and Drug Administration’s approval for the Pfizer vaccine for children between 5 and 11 years old could begin in November, possibly before Thanksgiving, a federal official with knowledge of the agency’s process told ABC News.

This prediction comes after Dr. Anthony Fauci said Tuesday kids will likely start getting vaccinated by late October.

Another official told ABC News that Pfizer has yet to complete its full submission, and that the FDA is not going to be rushed on this.

Pfizer submitted it initial data on younger children to the FDA earlier Tuesday.

The FDA already has scientists reviewing that initial data submitted by Pfizer, according to the official.

-ABC News’ Anne Flaherty and Eric Strauss

Sep 28, 5:07 pm
Forecasters expect US pandemic to continue to improve

The COVID-19 Forecast Hub’s ensemble forecast, used by the CDC, predicts that U.S. hospitalizations will continue to fall — perhaps to as low as 4,600 per day — by Oct. 11.

Forecasters say around 1,600 fewer people are likely to die over the next two weeks than during the past two weeks. In the two weeks ending Sept. 25, at least 27,755 people died from COVID-19 in the U.S. Over the next two weeks ending Oct. 19, just over 26,000 deaths are expected.

-ABC News’ Brian Hartman

Sep 28, 4:33 pm
Pfizer CEO says timeline on shots for kids up to FDA

Pfizer CEO Albert Bourla told The Atlantic Tuesday that the timeline on shots for children ages 5 to 11 is up to the FDA.

“I think it’s not appropriate for me to comment how long FDA will take to review the data. They should take as much time as they think it’s appropriate for them to have high levels of comfort,” Bourla said. 

“If approved, we will be ready to have the vaccine available,” he added.

Vaccines may be authorized and available for 5- to 11-year-olds in October or November.

Bourla said he thinks once kids get vaccinated, the U.S. will get a “strong push” toward herd immunity.

Bourla said he thinks booster protection from Pfizer vaccines will likely last one year.

-ABC News’ Cheyenne Haslett

Sep 28, 3:46 pm
More data on mixing/matching vaccines is coming within weeks, Fauci says

At Tuesday’s White House briefing, Dr. Anthony Fauci gave a loose timeline for when the FDA could have enough data to consider approving mixing and matching vaccines.

Moderna has already submitted data about using its shot as a booster for people who have received the Pfizer or Johnson & Johnson vaccines.  J&J will submit data on mixing its shot with the other vaccines in the next week, according to Fauci, and then Pfizer will submit its data within the first two weeks of October. Finally, the data will be examined by the FDA.

-ABC News’ Cheyenne Haslett

Sep 28, 3:43 pm
More data on mixing/matching vaccines is coming within weeks, Fauci says

At Tuesday’s White House briefing, Dr. Anthony Fauci gave a loose timeline for when the FDA could have enough data to consider approving mixing and matching vaccines.

Moderna has already submitted data about using its shot as a booster for people who have received the Pfizer or Johnson & Johnson vaccines.  J&J will submit data on mixing its shot with the other vaccines in the next week, according to Fauci, and then Pfizer will submit its data within the first two weeks of October. Finally, the data will be examined by the FDA.

-ABC News’ Cheyenne Haslett

Sep 28, 2:37 pm
Over 400K Americans got booster shot at pharmacies this weekend: White House

Over 400,000 Americans received a booster shot at a pharmacy since Friday and nearly 1 million more have scheduled appointments in the next few weeks, according to the White House.

The U.S. is expected to hit a milestone of 200 million Americans with at least one shot on Wednesday, White House COVID-⁠19 response coordinator Jeff Zients said.

The White House also touted another important milestone: racial equity in vaccinations nationwide.

According to a new Kaiser Family Foundation poll, 73% of Latinos and 70% of Black Americans have now gotten at least one shot, compared to 71% of white Americans. In May, this same poll found that 65% of white Americans were vaccinated compared to 56% of Black Americans.

-ABC News’ Cheyenne Haslett

Sep 28, 2:09 pm
US hospitalizations drop

At the beginning of the month, there were more than 104,000 patients hospitalized with COVID-19. As of Tuesday, there were 81,000 patients hospitalized — a drop of about 23,000 patients, according to federal data.

Nearly 50% of those patients — 11,000 — are from Florida, where cases and hospitalizations have been plummeting since mid-August.

In recent weeks, however, 16 states have reported higher hospital admission metrics, according to federal data: Colorado, Delaware, Idaho, Iowa, Maine, Maryland, Michigan, Minnesota, Nebraska, New Hampshire, North Dakota, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.

Five states — Alabama, Georgia, Idaho, Kentucky and Texas — have ICU capacities of 10% or less, according to federal data.

Alaska has the country’s highest case rate, followed by West Virginia, Wyoming, Montana, Idaho, North Dakota and Kentucky.

-ABC News’ Arielle Mitropoulos

Sep 28, 1:21 pm
Vaccine mandates work, NYC mayor says

New York City Mayor Bill de Blasio said there’s been a 45% increase in the daily vaccination rate since vaccine mandates were launched in July.

All city-run and private hospitals appear to be operating normally after health workers faced a midnight deadline to get vaccinated or risk losing their jobs. About 500 nurses for NYC Health + Hospitals are not at work.

NYC Health + Hospitals now has a 91% vaccination rate, up from 90% on Monday. City officials said about 5,000 employees were unvaccinated in the hospital system, down from more than 8,000 a week ago.

Northwell, New York state’s largest private hospital system, said it fired about two dozen “unvaccinated leaders,” management level or above, for not getting vaccinated.

“We are now beginning the process to exit the rest of our unvaccinated staff,” Northwell said in a statement.

-ABC News’ Aaron Katersky

Sep 28, 1:00 pm
3rd Pfizer dose has similar side effects to 2nd dose: Preliminary CDC data

A new preliminary CDC report of 306 people who received a third Pfizer dose found that side effects were similar to the second dose.

The most common side effects are fatigue, headache and a sore arm. These symptoms usually last one or two days.

The CDC will continue monitoring third doses for any potential new side effects or safety issues but says so far no “unexpected” patterns have been identified.

-ABC News’ Sony Salzman

Sep 28, 8:55 am
Pfizer submits initial child vaccine data to FDA

Pfizer on Tuesday submitted data for the Phase 2/3 vaccine trial for 5- to 11-year-olds to the FDA.

Pfizer will make a formal request for authorization in the coming weeks.

The FDA will review the data and make a decision, possibly by the end of October. The timeline for authorization is not set in stone.

Sep 27, 8:00 pm
Judge upholds NYC school staff vaccine mandate

A three-judge panel from the 2nd U.S. Circuit Court of Appeals has dissolved a temporary injunction that halted New York City’s vaccine mandate for school staff.

The panel offered no explanation and cleared the way for the city to enforcement the public school vaccine mandate.

“Vaccinations are our strongest tool in the fight against COVID-19 – this ruling is on the right side of the law and will protect our students and staff,” New York City’s Department of Education said in a statement.

As of Monday night, 87% of DOE employees, including 91% of teachers and 97% of principals, have at least one shot, according to the DOE.

Mayor Bill de Blasio said public school employees will have until the end of day Friday to get at least one dose of vaccine.

Michael Mulgrew, the president of the United Federation of Teachers, released a statement Monday night saying, “We will be working with our members to ensure, as far as possible, that our schools can open safely as the vaccine mandate is enforced.”

Sep 27, 7:02 pm
First lady Jill Biden receives booster shot

First lady Jill Biden received her COVID-19 booster shot Monday, according to Michael LaRosa, her spokesman.

The shot was administered at the White House in the afternoon, LaRosa told ABC News.

Sep 27, 6:10 pm
Judge rules Arizona ban on school mask mandate unconstitutional

An Arizona judge ruled Monday that the state’s ban on mask mandates in schools is unconstitutional.

Judge Katherine Cooper sided with the Arizona School Boards Association, which contended that the Arizona State Legislature’s law to ban school districts from issuing a mask mandate violates the state constitution’s title requirement and single subject rule.

The association argued that the legislature included policy regarding 30 subjects into one bill.

“The single subject rule precludes legislators from combining unrelated provisions into one bill to garner votes for disfavored measures. Together, these requirements promote transparency and the public’s access to information about legislative action,” the judge wrote in her decision.

The law was slated to go into effect on Sept. 29.

The state has until Nov. 1 to file an objection or response to the ruling.

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