The FDA authorizes children between 5 and 11 years of age – News Couple

The FDA authorizes children between 5 and 11 years of age

Jimmy Blank (left) holds her son Wade Ari Blank as he receives the Pfizer-BioNTech Covid-19 vaccine from health care worker Jane Feinberg (right) at the Jewish Federation/JARC offices in Bloomfield Hills, Michigan on May 13, 2021.

Jeff Kowalski | AFP | Getty Images

The Food and Drug Administration on Friday authorized the use of a Covid-19 vaccine from Pfizer and BioNTech for children ages 5 to 11, a move that will make vaccines available to 28 million children in the United States.

The Centers for Disease Control and Prevention must sign before distributing the shots. A meeting of the advisory committee to review pediatric doses is scheduled for next week, and it is expected to be cleared for general distribution immediately thereafter.

“As a mother and physician, I know that parents, caregivers, school staff, and children have been waiting for today’s permission. Vaccinating young children against COVID-19 will bring us closer to returning to a sense of normalcy,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement.

The FDA’s statement — which was expected — came after the Advisory Committee on Vaccines and Related Biological Products voted overwhelmingly on Tuesday to support a smaller dose of Pfizer’s vaccine for young children.

The company said its low-dose vaccine for children, which is one-third of the dose given to adults, is more than 90% effective in preventing symptomatic infections. She also said the doses were well tolerated in young children, resulting in side effects similar to those seen in a study of people ages 16 to 25.

Many parents say they are eager to get their children vaccinated as schools now open across the US and the delta type of coronavirus has led to a spike in children’s cases.

As of October 21, nearly 6.3 million children have tested positive for Covid since the outbreak began, according to the American Academy of Pediatrics, although health experts say the number is likely much higher. A CDC official told the Food and Drug Administration (FDA) committee on Tuesday that Covid-19 is the eighth highest killer of children ages 5 to 11 over the past year.

As of October 17, 691 deaths from Covid were reported in the United States for children under 18, with 146 deaths in the 5-11 age group, the Food and Drug Administration said Friday.

Ofer Levy, a voting member of the Food and Drug Administration’s Vaccine Advisory Committee, told CNBC that the number of child deaths from Covid at a similar level “has led to immunization against meningitis and other pediatric diseases.” Moreover, the vaccine is likely to help reduce the risk of transmission from children to the elderly.

The Biden administration said it has already purchased enough doses to vaccinate 28 million children ages 5 to 11 in the United States, and said it was ready to roll out the first 15 million shots in the first week after they were approved.

Dr. Peter Marks, the US Food and Drug Administration’s top vaccine regulator, said the US would likely have “a few more months off” before vaccines could be given to children under five.

“As we reach younger children, the benefits/risks have to be more carefully considered because young children are the least directly affected in terms of severe Covid-19,” he told reporters during a briefing late Friday.

FDA scientists note the risk of developing myocarditis and pericarditis, but say the benefits of the injections, including prevention of severe disease, hospitalization and death, generally outweigh the risks of rare inflammatory heart diseases.

Some members of the US Food and Drug Administration committee said Tuesday that vaccinating younger age groups will help the United States move toward the “endemic” phase of Covid, where the virus is still spreading but at lower levels than it is now.

More than 2,000 Covid-related schools across the country have been closed since August, affecting more than 1 million children and 68,000 teachers, said CDC official Dr. Fiona Havers, citing Google News data.

Other panelists noted that there were unknowns, such as the rate of myocarditis in young children, but emphasized that the benefits of the injections outweighed the risks.

One member questioned whether a recommendation should be issued only to children at risk. Studies have shown that healthy children are less likely to develop symptoms of the disease despite having similar rates of infection to adults.

The CDC analysis identified underlying medical conditions — such as obesity, chronic lung disease, and neurological disorders — as risk factors for severe childhood illness. The most common underlying medical condition, the agency said, is lung disease, particularly asthma.

CNBC Robert Toy Contribute to this report.

Correction: This story has been updated to reflect the over 90% effectiveness of the Pfizer vaccine in preventing symptomatic infections.

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