CDC advisers recommend Pfizer’s low-dose COVID vaccine for kids : Shots

Pfizer-BioNTech’s COVID-19 vaccine for young children is a low-dose formulation of the adult vaccine. It was found to be safe and about 91% effective in preventing COVID-19.

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Paul Hansie / Supa Images / Light Rocket by Getty

Pfizer-BioNTech’s COVID-19 vaccine for young children is a low-dose formulation of the adult vaccine. It was found to be safe and about 91% effective in preventing COVID-19.

Paul Hansie / Supa Images / Light Rocket by Getty

The Centers for Disease Control and Prevention recommends that all children between the ages of 5 and 11 be vaccinated with the low-dose COVID-19 vaccine developed by Pfizer-BioNTech.

The move clears the way for shots to be managed as soon as tomorrow, although it may take a few days for the vaccine to become widely available.

CDC Director Rochelle Valensky issued the recommendation on Tuesday, just hours after a unanimous vote by the CDC’s Advisory Committee on Immunization Practices, which supports the use of vaccines for children this age.

Valensky’s decision means that about 28 million children between the ages of 5 and 11 will be eligible for the shots.

In a statement, President Biden called the decision a “turning point in our fight against COVID-19” and said the federal government had purchased a low-dose baby vaccine for “every child in the United States.”

Delivery of the vaccine began last Friday following the Food and Drug Administration’s decision to allow the vaccine in this age group. White House COVID-19 Response Coordinator Jeffrey Zentz said about 15 million doses are being sent this week, and the federal vaccine distribution program will be “fully operational” by next Monday, November 8.

Some school districts have scheduled a vaccination campaign in the weeks leading up to the Thanksgiving holiday, although some districts have said they will not provide vaccines through schools.

The Pfizer-BioNTech pediatric vaccine is one-third of the adult dose and, like the adult formulation, is given in two doses at three-week intervals. Pfizer says the low-dose diet was chosen to reduce side effects and still build a strong immune system.

Ahead of Tuesday’s advisory committee meeting, Valensky called it a “memorable day” as he urged the panel to consider the harm to children of COVID-19. Of The latest CDC data Show that 172 children between the ages of 5 and 11 have died from COVID-19 and more than 8,300 have been hospitalized.

“We also know that in addition to the medical effects of COVID on children, there are also detrimental effects on social and mental health that we are just beginning to fully understand,” Valensky told the panel. “It is our continued responsibility to ensure that as many people as possible are vaccinated and protected from COVID-19.”

There is no doubt from his statements that he supported a broad recommendation to vaccinate all children between the ages of 5 and 11.

The vaccine is being sent to the offices of pediatricians and family doctors, as well as to community health centers, pharmacies, tribal health centers and other providers, Zants said. In some areas, school-based vaccine administration sites will also be included.

Giants said parents would not need a doctor’s order to be vaccinated, although parents with questions wanted to talk to a trusted healthcare provider about the vaccine.

In a statement announcing his decision, Valensky emphasized the point. “As a mother, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist so they can learn more about the vaccine and their children,” she said. The importance of getting vaccinated, “he said.

During Tuesday’s meeting of the CDC’s advisory committee on immunizations, panel members reviewed the science behind the FDA’s approval of the vaccine in all children between the ages of 5 and 11 on Friday. And discussed it. The permission was based largely on a Pfizer-BioNTech study of 4,600 children worldwide, of whom about 3,100 received a low-dose vaccine and about 1,500 received a placebo.

These studies show that the vaccine is about 91% effective against COVID-19. The immune response to the vaccine, as measured by antibodies, was comparable to that seen in 16- to 25-year-olds.

Counselors spent a lot of time weighing the public health need for a children’s vaccine for a disease that is often not as severe or fatal as adults. Finally, the spread of COVID-19 across the United States and the number of serious cases and deaths forced them to recommend the global use of the vaccine in the 5-11 age group.

The latest CDC data for September 2021 shows that 38% of children between the ages of 5 and 11 have antibodies against the virus that causes COVID-19, which shows that That they have been affected. Dr. Jefferson Jones, CDC’s medical officer, said young children are at least as likely to become infected as adults. More than 1.9 million cases have been reported in children between the ages of 5 and 11.

In total, more than 8,300 children between the ages of 5 and 11 are hospitalized with COVID-19. More than 2,300 children of this age have contracted a related disease called MIS-C, a serious condition that affects many organs and can be fatal. Children in the 5-11 age group had the highest number of MIS-C cases.

According to Jones, the hospitalization rate for COVID-19 in this age group and the severity of hospital admissions are similar to those seen for influenza in previous years.

Jones said the hospitalization rate for COVID-19 is three times higher for non-Hispanic black, non-Hispanic American Indian / Alaska Native, and non-Hispanic white children for Hispanic children.

A relatively rare side effect that sparked much discussion at Tuesday’s meeting was myocarditis, a form of heartburn. It also occurs as a complication of several viral infections, including COVID-19, and is more common in adolescents and young adults. It usually clears up in weeks or months.

The CDC has confirmed 877 cases of myocarditis in people aged 30 and under after the Pfizer or Moderna vaccine, but no deaths have been reported, said Dr. Matthew Oster, who has been diagnosed with myocarditis for CDC. Studies and is a pediatric cardiologist at Children’s Healthcare in Atlanta. . He explained that COVID-19 itself can cause myocarditis and other heart-related problems, including MIS-C, which often affects the heart.

“The most important thing is to get COVID, I think it’s more risky for the heart than getting this vaccine,” Oyster said.

In terms of safety, some who testified during public comment, as well as other commentators, questioned whether the study used by the FDA to allow emergency use was large enough to convince parents. The vaccine is safe in young children.

In response, Dr. Doran FunkThe Clinical Deputy Director of the FDA’s Division of Vaccines and Related Products Applications told the meeting that the size of the protective database for this age group is “at the top – or even higher” of the size of the protective database. It has supported other people’s licenses. Vaccines to prevent infectious diseases. “

CDC’s Dr. Sarah Oliver said that according to CDC models, vaccination of children aged 5 to 11 starting this month could potentially prevent 600,000 cases of COVID-19 by March next year. Vaccination of children between the ages of 5 and 11 “will get wet, but will not end,” he said, adding that a new form could emerge.

Acknowledging that some parents are reluctant to vaccinate their children immediately, Dr. Matthew Daly, a member of the advisory committee, said, “We hear you out loud and clear.”

“Of course you only want what is best for your child,” he said. “I encourage you to talk to your family physician or pediatrician. [so] They can go through it with you. “

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