CORONAVIRUS

Pfizer/BioNTech submit initial data on COVID-19 vaccine for people ages 5 to 11 to FDA, but aren’t seeking EUA yet

Sep 28, 2021, 6:46 AM
FILE (Photo by Justin Tallis - Pool / Getty Images)...
FILE (Photo by Justin Tallis - Pool / Getty Images)
(Photo by Justin Tallis - Pool / Getty Images)

(CNN) — Pfizer and BioNTech said Tuesday they have submitted COVID-19 vaccine data on children ages 5 to 11 to the U.S. Food and Drug Administration for initial review, but are not yet seeking emergency use authorization.

A formal submission to request EUA for the vaccine is expected to follow in the coming weeks, the companies said in a statement.

Submissions to the European Medicines Agency and other regulatory authorities are also planned, they said.

This is the first submission of data to the FDA for a COVID-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.

Last week, Pfizer released details of a Phase 2/3 trial that showed its COVID-19 vaccine was safe and generated a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10-microgram dose — smaller than the 30-microgram dose that has been used for those 12 and older.

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.”

Pfizer and BioNTech said Tuesday they plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

FDA officials have said that once vaccine data was submitted, the agency could authorize a vaccine for younger children in a matter of weeks — not months — but it would depend on the timing and quality of the data provided.

The FDA has moved quickly in the past to extend vaccine authorization to additional groups. For example, Pfizer sought emergency use authorization for its COVID-19 vaccine for people ages 12 to 15 on April 9 and the EUA was granted May 10.

However, for these younger children, FDA is expected to convene its vaccine advisers to make a recommendation on the vaccine before authorization. If the FDA OKs it, a panel of CDC vaccine advisers will meet to consider whether to recommend its use.

Following the announcement from Pfizer and BioNTech on Tuesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said hopefully vaccines can go into arms by the end of October.

“The FDA takes very seriously the importance of getting vaccines shown to be safe and effective in children to getting it into the arms of children, in this case, children from 11 down to 5,” Fauci said on MSNBC’s Morning Joe Tuesday. “The FDA, you never want to get ahead of their judgment, but I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the OK so that we could start vaccinating children, hopefully before the end of October.”

Data on the immune response and safety for two more age groups — children ages 2 to 5 and 6 months to 2 years — are expected “as soon as the fourth quarter of this year,” Pfizer and BioNTech said Tuesday.


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

KSL 5 TV Live

Top Stories

Coronavirus

CHICAGO, ILLINOIS - SEPTEMBER 09: A pharmacist prepares to administer  COVID-19 vaccine booster sho...
Jed Boal

University Health recommends getting omicron booster and flu shot now

The CDC approved the COVID-19 bivalent boosters that target the most recent omicron variants on September 1. Since then, tens of thousands of Utahns have rolled up their sleeves.
7 days ago
FILE: Pfizer-BioNTech COVID-19 (left) and Moderna COVID-19 (right) vaccines are seen at a vaccinati...
Jed Boal

Despite reaching 5,000 deaths, Utah’s COVID-19 numbers are down

The director of the World Health Organization said yesterday about COVID-19, “the end is in sight,” even if we are not there yet.
18 days ago
FILE PHOTO (Photo by Al Bello/Getty Images)...
Associated Press

WHO: COVID end ‘in sight,’ deaths at lowest since March 2020

The head of the World Health Organization says the number of coronavirus deaths last week was the lowest reported number in the pandemic since March 2020, marking what could be a turning point in the years-long global outbreak.
18 days ago
A school classroom with chairs and desks...
Brooke Williams

Project to provide air purifiers in Utah K-12 classrooms

Cleaner air improves student performance, decreases COVID transmission and school absenteeism. New project provides air purifiers for classrooms in Utah.
19 days ago
SHANGHAI, CHINA - JULY 08: People walk by a closed store at a neighborhood designated as a medium-r...
Laura He, CNN Business

Zero- COVID-19 at what price? Chinese researchers are treading on sensitive ground

Authorities in Shanghai have denied a report by a leading Chinese real estate research firm that claimed more than a third of shops in a major mall had been shuttered because of strict COVID-19 curbs.
21 days ago
FILE: Pfizer-BioNTech COVID-19 (left) and Moderna COVID-19 (right) vaccines are seen at a vaccinati...
LAURA UNGAR AP Science Writer

Is COVID-19 winding down? Scientists say no

New booster shots have arrived and social distancing guidelines have eased but COVID-19 infections aren't going away anytime soon. Experts predict the scourge that's already lasted longer than the 1918 flu pandemic will linger far into the future as the virus continues to cause deaths and may well mutate or evolve into a new disease.
25 days ago

Sponsored Articles

Portrait of smiling practitioner with multi-ethnic senior people...
Summit Vista

How retirement communities help with healthy aging

There are many benefits that retirement communities contribute to healthy aging. Learn more about how it can enhance your life, or the life of your loved ones.
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to choose what MBA program is right for you: Ask these questions before you apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
Cloud storage technology with 3d rendering drawer with files in cloud...
PC Laptops

How backing up your computer can help you relieve stress

Don't wait for something bad to happen before backing up your computer. Learn how to protect your data before disaster strikes.
young woman with stickers on laptop computer...
Les Olson

7 ways print marketing materials can boost your business

Custom print marketing materials are a great way to leave an impression on clients or customers. Read for a few ideas to spread the word about your product or company.
young woman throwing clothes to organize a walk in closet...
Lighting Design

How to organize your walk-in closet | 7 easy tips to streamline your storage today

Read our tips to learn how to organize your walk-in closet for more storage space. These seven easy tips can help you get the most out of your space.
Types of Computer Malware and Examples...
PC Laptops

5 Nasty Types of Computer Malware and Examples | Everything You Need to Know to Keep Your Computer and Family Safe

Here are the different types of computer malware and examples that could potentially infect your computer.
Pfizer/BioNTech submit initial data on COVID-19 vaccine for people ages 5 to 11 to FDA, but aren’t seeking EUA yet