FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11
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
In The News
WASHINGTON — President Joe Biden said he will unveil plans this week on how his administration will work to slow... Read More
WASHINGTON — President Joe Biden said he will unveil plans this week on how his administration will work to slow the spread of the new COVID-19 variant, known as omicron, which emerged in South Africa and has been classified by the World Health Organization as a... Read More
TOKYO (AP) — The omicron variant kept a jittery world off kilter Wednesday as Japan further tightened travel restrictions, infections... Read More
TOKYO (AP) — The omicron variant kept a jittery world off kilter Wednesday as Japan further tightened travel restrictions, infections linked to the new version of the coronavirus popped up in more places and new evidence made clear the mutant strain was circulating weeks earlier than... Read More
NEW YORK (AP) — Global shares mostly slipped Tuesday as investors cautiously weighed how much damage the new omicron coronavirus... Read More
NEW YORK (AP) — Global shares mostly slipped Tuesday as investors cautiously weighed how much damage the new omicron coronavirus variant may unleash on the global economy. Germany's DAX lost 1.1% to 15,106.35 in afternoon trading. France’s CAC 40 slipped 0.9%, while Britain's FTSE 100 shed... Read More
WASHINGTON — President Joe Biden addressed the nation Monday, calling the new omicron variant of the coronavirus a cause for... Read More
WASHINGTON — President Joe Biden addressed the nation Monday, calling the new omicron variant of the coronavirus a cause for concern “but not a cause for panic.” Speaking in the Roosevelt Room of the White House, as Dr. Anthony Fauci, director of the National Institute of... Read More
WASHINGTON (AP) — President Joe Biden will urge Americans to get vaccinated and to receive a booster shot as he... Read More
WASHINGTON (AP) — President Joe Biden will urge Americans to get vaccinated and to receive a booster shot as he seeks to quell concerns Monday over the new COVID-19 variant omicron, but won't immediately push for more restrictions to stop its spread, his chief medical adviser said.... Read More
WASHINGTON (AP) — Both sides are telling the Supreme Court there's no middle ground in Wednesday's showdown over abortion. The justices can... Read More
WASHINGTON (AP) — Both sides are telling the Supreme Court there's no middle ground in Wednesday's showdown over abortion. The justices can either reaffirm the constitutional right to an abortion or wipe it away altogether. Roe v. Wade, the landmark 1973 ruling that declared a nationwide right to abortion, is... Read More