US: Pfizer COVID-19 shot appears effective for kids under 5

Jun 12, 2022, 4:35 PM | Updated: Jun 14, 2022, 10:34 pm
FILE - Syringes and colorful bandages are prepared as children from local schools prepare to get CO...

FILE - Syringes and colorful bandages are prepared as children from local schools prepare to get COVID-19 vaccines in Pittsfield, Mass., on Monday Dec. 13, 2021. A review by federal health officials finds that Pfizer's COVID-19 vaccine appears safe and effective for children under 5, the only group not currently eligible for vaccination. The review issued Sunday, June 12, 2022, by the Food and Drug Administration is a key step toward a decision on vaccinations for babies, toddlers and preschoolers, perhaps as soon as June 21. (Ben Garver/The Berkshire Eagle via AP, File)

(Ben Garver/The Berkshire Eagle via AP, File)

WASHINGTON (AP) — Federal health officials said Sunday that kid-sized doses of Pfizer’s COVID-19 vaccines appear to be safe and effective for kids under 5, a key step toward a long-awaited decision to begin vaccinating the youngest American children.

The Food and Drug Administration posted its analysis of the Pfizer shot ahead of a Wednesday meeting where outside experts will vote on whether the shots are ready for the nation’s 18 million babies, toddlers and preschoolers. Kids under 5 are the only group not yet eligible for COVID-19 vaccination in the U.S.

Late last week the FDA posted a similar analysis of Moderna’s shots for children under 6.

If regulators clear the shots by one or both companies, vaccinations could begin as soon as next week with the drugmakers ready to rapidly ship doses ordered by the government. Parents have been pressing federal officials for months for the opportunity to protect their smallest children as more adults shed masks and abandon other public health precautions.

While only about 3% of U.S. COVID cases are in the age group 6 months to 4 years, hospitalization and death rates in that group are higher than those for older children, according to the FDA’s analysis — one reason experts have said protecting this group is important.

The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer.

Pfizer’s vaccine, given as a three-shot series, appeared 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed among study participants. The figure could change as Pfizer’s study continues.

Moderna’s two-dose series was only about 40% to 50% effective at preventing milder infections, though the two companies’ shots were tested at different times during the pandemic, when different variants were circulating. Moderna has begun testing a booster for tots.

On Wednesday, the FDA will ask an independent panel of vaccine experts to debate both companies’ data before voting. The FDA is not required to follow the group’s recommendations, but the process is seen as a key step in publicly vetting the shots.

The FDA is expected to make its official decision shortly after Wednesday’s all-day meeting. The next step: the Centers for Disease Control and Prevention, which recommends how to use vaccines, will convene its own expert panel to debate which tots need vaccinations.

It’s not clear how much demand there will initially be for the shots. A recent survey suggests only 1 in 5 parents of young children would get their kids vaccinated right away. Vaccines have been available since November for older U.S. schoolchildren, yet less than a third of those ages 5 to 11 have gotten the two recommended doses, according to government figures.

For the youngest children, each company is offering different dose sizes and number of shots, beginning at 6 months through 4 years for Pfizer and through 5 years for Moderna.

Pfizer and its partner BioNTech plan to offer two shots three weeks apart followed by a third at least two months later — each one-tenth the dose given to adults. Pfizer is currently the only company with a COVID-19 vaccine for older U.S. children.

Moderna is seeking FDA clearance for two shots, each a quarter of its adult dose, given about four weeks apart.

The FDA currently allows Moderna’s vaccine to be used only in adults. But some countries allow full-size doses for teens and half-size shots for kids ages 6 to 11 — a step the FDA also is considering.

More than 30,000 U.S. children younger than 5 have been hospitalized with COVID-19 and nearly 500 coronavirus deaths have been reported in that age group, according to U.S. health officials.

The government allowed pharmacies and states to start placing orders for tot-sized doses last week, with 5 million initially available — half made by Pfizer and half by Moderna.

____

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

FILE - Coal miner Scott Tiller takes shelter from the rain after coming out of an underground mine ...
Associated Press

Senate climate bill has West Virginia written all over it

CHARLESTON, W.Va. (AP) — The sprawling economic package passed by the U.S. Senate this week has a certain West Virginia flavor. The package, passed with no Republican votes, could be read largely as an effort to help West Virginia look to the future without turning away entirely from its roots. The bill contains billions in […]
11 hours ago
This image released by HBO Max shows promotional art for the film "The Princess," a documentary pre...
Associated Press

In ‘The Princess,’ a documentary on Diana flips the focus

The last thing the world needs, you might think, is another Princess Diana documentary. It’s a fair thought considering that almost 25 years after her death, her life and impact is still media fodder. Whether it’s a magazine cover or a book claiming to have new revelations or just an image of Kristen Stewart in […]
11 hours ago
Wake County Sheriff deputies work at the scene where a deputy was shot and killed in eastern Wake C...
Associated Press

North Carolina deputy killed; search on for shooter

RALEIGH, N.C. (AP) — A sheriff’s deputy was killed along a dark stretch of road in North Carolina and authorities were searching Friday for whoever fired the shots. “We will find who’s responsible for this loss. Even in the midst of the hurt and the pain, we ask for prayers, we ask for patience as […]
11 hours ago
FILE — Connecticut Attorney General William Tong speaks to the media during a watch party for the...
Associated Press

Feds agree to honor Connecticut pardons, stop deportations

HARTFORD, Conn. (AP) — Federal officials have agreed to recognize Connecticut pardons as legally valid again and stop deporting people who have been pardoned for their crimes by a state board, reversing a hard-line stance taken by the Trump administration, authorities announced Friday. Connecticut Attorney General William Tong said the departments of Justice and Homeland […]
11 hours ago
Associated Press

Creighton students’ COVID vaccine mandate appeal dismissed

OMAHA, Neb. (AP) — The Nebraska Supreme Court on Friday dismissed an appeal by a handful of Creighton University students who sought to be exempt from the private Catholic school’s COVID-19 vaccine mandate last year, arguing that getting the shots would violate their religious beliefs against abortion. The state’s high court said it didn’t have […]
11 hours ago
Author Salman Rushdie is tended to after he was attacked during a lecture, Friday, Aug. 12, 2022, a...
Associated Press

Author Salman Rushdie attacked on lecture stage in New York

CHAUTAUQUA, N.Y. (AP) — Salman Rushdie, the author whose writing led to death threats from Iran in the 1980s, was attacked and apparently stabbed in the neck Friday by a man who rushed the stage as he was about to give a lecture in western New York. An Associated Press reporter witnessed a man confront […]
11 hours ago

Sponsored Articles

...
Day & Night Air Conditioning, Heating and Plumbing

Ways to prevent clogged drains and what to do if you’re too late

While there are a variety of ways to prevent clogged drains, it's equally as important to know what to do when you're already too late.
...
Mayo Clinic Orthopedics and Sports Medicine

Why your student-athlete’s physical should be conducted by a sports medicine specialist

Dr. Anastasi from Mayo Clinic Orthopedics and Sports Medicine in Tempe answers some of the most common questions.
...
Carla Berg, MHS, Deputy Director, Public Health Services, Arizona Department of Health Services

Update your child’s vaccines before kindergarten

So, your little one starts kindergarten soon. How exciting! You still have a few months before the school year starts, so now’s the time to make sure students-to-be have the vaccines needed to stay safe as they head into a new chapter of life.
US: Pfizer COVID-19 shot appears effective for kids under 5