Covid-19 vaccine for 5- to 11-year-olds is safe and shows ‘robust’ antibody response, Pfizer says

Sep 20, 2021, 6:43 AM | Updated: 6:50 am

FILE: A nurse reaches for a vial of Pfizer-BioNTech Covid-19 vaccine at a pop up vaccine clinic in ...

FILE: A nurse reaches for a vial of Pfizer-BioNTech Covid-19 vaccine at a pop up vaccine clinic in the Arleta neighborhood of Los Angeles, California, August 23, 2021. Photo credit: Robyn Beck AFP via Getty Images.

    (CNN) — In a highly anticipated announcement, 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These are the first such results released for this age group for a US Covid-19 vaccine, and the data has not yet been peer-reviewed or published.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 US Food and Drug Administration for emergency use authorization soon.

The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. These trials used a 10-microgram dose — smaller than the 30-microgram dose that has been used for those 12 and older.

“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a news release.

Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

“Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said.

A Pfizer spokesperson also confirmed that were no instances of myocarditis, a type of heart inflammation that has been linked with mRNA vaccines.

Pfizer said these data will be included in a “near-term submission” for EUA and the companies will continue to accumulate the data needed to file for FDA approval for people ages 5 to 11.

The Pfizer/BioNTech vaccine is currently approved for people age 16 and older, and authorized for use in people ages 12 to 15.

Pfizer said it is expecting trial data for children as young as 6 months “as soon as the fourth quarter of this year.”

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the statement.

Dr. Scott Gottlieb, a former FDA commissioner and current Pfizer board member, has said a vaccine for children ages 5 to 11 could be available by Halloween.

Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of FDA’s Center for Biologics Research and Evaluation, said in a statement this month that the agency would review data for a vaccine for younger children “as quickly as possible, likely in a matter of weeks rather than months,” once it was submitted for authorization.

“However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers,” they wrote.

Calls for a Covid-19 vaccine for younger children have grown louder in recent months as cases surged among children.

Coronavirus infections have risen “exponentially” among children across the United States, and now account for nearly 29% of all cases reported nationwide, the American Academy of Pediatrics reported last week.

Still, US health officials have emphasized that children are not just small adults, and even those approaching age 12 should not be given the larger vaccine dose available for older people.

“We don’t want children to have adverse effects. Granted, we want them to be able to get vaccinated as quickly as possible, but let’s do it right,” FDA’s Marks said in a fireside chat hosted by the ResearchAmerica Alliance last week.

“There is a difference here because they’re not just getting the same-old, same-old dose as a 12 and up person will. They have to get a reduced dose. And that’s why it’s not a good idea for doctors to take things in their own hands at this point.”

The-CNN-Wire
™ & © 2021 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.


How To Prevent the Spread of COVID-19 Coronavirus

COVID-19 coronaviruses transmitted from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:

  • Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
  • Wear a mask.
  • Don’t touch your face.
  • Keep children and those with compromised immune systems away from someone who is coughing or sneezing (in this instance, at least six feet)
  • If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities.)
  • Get a flu shot.
  • Get vaccinated.

Local resources

KSL Coronavirus Q&A

Utah’s Coronavirus Information

Utah State Board of Education

Utah Hospital Association

The Church of Jesus Christ of Latter-day Saints

Utah Coronavirus Information Line – 1-800-456-7707

National Resources

Centers for Disease Control and Prevention

Commonly asked questions, World Health Organization

Cases in the United States

 

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

Traffic moves on I-15 in Salt Lake City on Thursday, May 18, 2023. UDOT says we will see heavy traf...

Britt Johnson

Easter weekend and spring break will bring heavy traffic this weekend, UDOT predicts

Spring Break and Easter could team up this weekend to create some heavy traffic. 

8 minutes ago

"Burn Book," by longtime Silicon Valley reporter Kara Swisher is seen, Friday, Feb. 23, 2024, in Sa...

Jeff Caplan

Jeff Caplan’s Minute of News: Telling tales about tech bros

Kara Swisher’s new book paints an ugly picture of Silicon Valley.

2 hours ago

pets...

Curt Gresseth

Don’t surrender pets to a shelter. Send in a pro to reverse bad behavior, says Utah trainer

An expert discusses controlling the unwanted behavior of pets.

2 hours ago

Exclusive video obtained by KSL NewsRadio shows Salt Lake hit-and-run in the Avenues neighborhood. ...

Eric Cabrera

WATCH: Exclusive video shows woman survives Salt Lake City hit and run

KSL NewsRadio has exclusively obtained footage of a Salt Lake City hit-and-run, where a woman was struck while out for a run in the Avenues.

2 hours ago

Defense attorney John Prior questions David Warwick during Chad Daybell's preliminary hearing in Fr...

Emma Keddington

Judge orders gag order for upcoming Chad Daybell case

Judge Steven Boyce has issued a gag order in the Chad Daybell case, after Daybell's attorney spoke with a media outlet.

2 hours ago

colorado river...

Adam Small

More than half of the Colorado River’s water is being used for farming, study finds

The Colorado River provides water to 40 million people in seven states, including Utah, as well as Mexico.

2 hours ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

Covid-19 vaccine for 5- to 11-year-olds is safe and shows ‘robust’ antibody response, Pfizer says