facebook linkedin twitter

FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11

October 29, 2021 by Dan McCue
In this June 6, 2021 file photo, a youth receives a Pfizer-BioNTech COVID-19 vaccine in the central Israeli city of Rishon LeZion. (AP Photo/Sebastian Scheiner)

WASHINGTON — The Food and Drug Administration on Friday authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 to 11.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” said Acting FDA Commissioner Dr. Janet Woodcock in a written statement announcing the decision.

“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Woodcock continued, adding, “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

If the Centers for Disease Control and Prevention signs off, as is expected when its Advisory Committee on Immunization Practices meets next week, children could start getting shots as early as Wednesday.

The FDA said in a press release Friday that children 5 to 11 would be administered a two-dose primary series, three weeks apart, but at a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

The agency went on to say that in a study involving 3,100 children aged 5 to 11, the immune response was comparable to those in earlier studies on individuals aged 16 to 25. In that study, the vaccine was deemed to be about 90.7% effective.

In addition, the FDA said no serious adverse effects have been detected in the ongoing study.

The Biden administration has promised that children’s shots will be easily accessible at pediatrician offices, community health centers, children’s hospitals and pharmacies, with 15 million doses ready to ship immediately.

States started ordering doses last week, under a formula based on how many children they have in the age group. While the school year is already well underway, the pediatric dose is arriving in time for the holidays, giving more comfort to families looking to gather older and younger people together for the first time since the early months of 2020.

According to the CDC, COVID-19 cases in children 5 to 11 comprise about 39% of cases in individuals younger than 18 years of age. 

In addition, the Centers said approximately 8,300 COVID-19 cases in children 5 to 11 resulted in hospitalization. 

As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals younger than 18 years of age, with 146 deaths in the 5 to 11 age group, the CDC said.

“Today is a momentous day in the fight against the COVID-19 pandemic, with the FDA’s first emergency use authorization of a coronavirus vaccine for younger children,” House Speaker Nancy Pelosi said in a statement. 

“Congress and the country are grateful to our scientists and health officials, who worked quickly and carefully to ensure that the Pfizer vaccine is safe and effective for our youngest Americans,” she said. “Getting our children vaccinated is the best way to ensure their health and safety, so they can go to school, spend time with their families and engage in our communities with the confidence of knowing they are protected from this vicious virus.

“It is heartbreaking that more than a thousand Americans lose their lives to this virus each day, nearly all of whom were unvaccinated. It is now crucial that every eligible American — especially children ages five to eleven — get vaccinated as quickly as possible, so that we can finally put an end to this pandemic,” Pelosi added.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

A+
a-

Health

December 8, 2021
by Alexa Hornbeck
White House to Implement Policy to Cover the Cost of COVID-19 Testing

WASHINGTON — President Joe Biden recently implemented new actions to protect Americans against COVID-19 variants this winter, including a new... Read More

WASHINGTON — President Joe Biden recently implemented new actions to protect Americans against COVID-19 variants this winter, including a new policy beginning Jan. 15 to expand at-home testing. “More than 150 million Americans with private insurance, who are now able to get tests covered in physician... Read More

December 8, 2021
by Alexa Hornbeck
Digital Health Companies Look to Improve Access to Culturally Competent Care

The COVID-19 pandemic has transformed the use of telehealth and now many digital health companies are seeking to revolutionize access... Read More

The COVID-19 pandemic has transformed the use of telehealth and now many digital health companies are seeking to revolutionize access to care for communities of color.  “I saw all these different solutions popping up and wondered how I could fine tune these innovations to what Black... Read More

Pfizer Says COVID Booster Offers Protection Against Omicron

Pfizer said Wednesday that a booster dose of its COVID-19 vaccine may offer important protection against the new omicron variant even though... Read More

Pfizer said Wednesday that a booster dose of its COVID-19 vaccine may offer important protection against the new omicron variant even though the initial two doses appear significantly less effective. Pfizer and its partner BioNTech said that while two doses may not be protective enough to prevent infection,... Read More

December 6, 2021
by Brock Blasdell
NYC to Expand COVID-19 Vaccination Mandates to Children

NEW YORK — Mayor Bill de Blasio announced on Monday that, in an effort to combat the omicron variant, children... Read More

NEW YORK — Mayor Bill de Blasio announced on Monday that, in an effort to combat the omicron variant, children aged 5-11 will soon be required to present proof of at least one COVID-19 vaccination before they can enter any private indoor business within New York... Read More

December 5, 2021
by Dan McCue
Dobbs Now Supreme Court’s Most Anticipated Decision In Years

WASHINGTON — It wasn’t even the top headline in The New York Times the day after the decision was announced.... Read More

WASHINGTON — It wasn’t even the top headline in The New York Times the day after the decision was announced. That distinction went to the death of former President Lyndon Baines Johnson, who had died at age 64 after suffering a heart attack at his ranch... Read More

Omicron May Be Driving South Africa's Surge; Wary World Watches

JOHANNESBURG (AP) — Dr. Sikhulile Moyo was analyzing COVID-19 samples in his lab in Botswana last week when he noticed... Read More

JOHANNESBURG (AP) — Dr. Sikhulile Moyo was analyzing COVID-19 samples in his lab in Botswana last week when he noticed they looked startlingly different from others. Within days, the world was ablaze with the news that the coronavirus had a new variant of concern, which appears to be... Read More

News From The Well
scroll top