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FDA accepted for youngsters ages 5 to 11

Jamie Blank (L) holds her son Ari Blank’s hand when he was born on Jan.

Jeff Kowalsky | AFP | Getty Images

The Food and Drug Administration on Friday approved the use of Pfizer and BioNTech’s Covid-19 vaccine for children ages 5-11

The Centers for Disease Control and Prevention must check out before shots can be distributed. An advisory committee meeting is scheduled to review pediatric doses next week and is expected to be released for public distribution quickly immediately thereafter.

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

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

The company said its low-dose vaccine for children, which is one-third the dose for adults, is more than 90% effective in preventing symptomatic infection. It also said the shots were well tolerated in young children and caused side effects comparable to those seen in a study of people aged 16-25.

Many parents say they are anxious to get their children vaccinated now that schools are open in the US and the delta variant of the coronavirus is causing an increase in child cases.

As of October 21, nearly 6.3 million children have tested positive for Covid since the pandemic began, according to the American Academy of Pediatrics, although health experts say the number is likely much higher. Covid-19 is the eighth most common killer of children ages 5-11 in the past year, a CDC official told the FDA committee on Tuesday.

As of October 17, 691 deaths from Covid in children under the age of 18 had been reported in the United States, including 146 deaths in the age group 5 to 11, the FDA said on Friday.

The number of child deaths from Covid is at a similar level, “which has resulted in immunization against meningitis and other childhood diseases,” said Dr. Ofer Levy, a voting member of the FDA’s Vaccine Advisory Board, told CNBC. “The vaccine is also likely to help reduce the risk of transmission from children to the elderly.”

The Biden government has said it has already procured enough doses to vaccinate all 28 million 5-11 year olds in the U.S. and that it is ready to roll out the first 15 million vaccinations in the first week after approval .

Dr. Peter Marks, the FDA’s lead vaccine regulator, said the US is likely to have “a few more months free” before vaccines are approved for children under the age of 5.

“With younger children, the benefits / risks are weighed even more carefully as the youngest children are least directly affected by severe Covid-19,” he told reporters during a briefing late Friday.

FDA scientists have identified the risk of myocarditis and pericarditis, but said the benefits of the syringes, including preventing serious illness, hospitalizations, and death, would generally outweigh the risk of rare inflammatory heart disease.

Some members of the FDA committee said Tuesday that vaccinating younger age groups would help the US move towards the “endemic” phase of Covid, where the virus is still circulating but at lower levels than it is now.

There have been more than 2,000 Covid-related school closings nationwide since August, affecting more than 1 million children and 68,000 teachers, said CDC official Dr. Fiona Havers on Tuesday, citing data from Google News.

Other committee members noted that there are unknowns like the rate of myocarditis in young children, but stressed that the benefits of syringes outweigh the risks.

One member wondered if they should make recommendations only for children at risk. Studies have shown that otherwise healthy children are less likely to have symptoms of the disease, even though they become infected at rates similar to adults.

A CDC analysis identified underlying diseases – such as obesity, chronic lung disease, and neurological disorders – as risk factors for serious illness in children. The most common underlying disease is lung disease, especially asthma, the agency said.

CNBCs Robert Towey contributed to this report.

Correction: This story has been updated to show that Pfizer’s vaccine is greater than 90% effective in preventing symptomatic infections.

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