About 28 million children from 5 years old will soon be able to get vaccinated against COVID-19

About 28 million children aged 5 to 11 in the United States may soon be eligible for the COVID-19 vaccine, and plans are already underway to help them get those shots. The publication told about this in more detail. CNN.

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The FDA's Independent Vaccine Advisory Board will meet on Tuesday, October 26 to discuss whether Pfizer / BioNTech's COVID-19 vaccine should be allowed for young children. If permitted, it will be the first vaccine available for children of this age. The Pfizer vaccine is already licensed for children 12 to 15 years old and approved for people ages 16 and older.

If the FDA committee votes in favor, then the FDA will accept the vaccination recommendation.

Then, on November 2 and 3, an independent advisory committee from the US Centers for Disease Control and Prevention (CDC) will meet and vote on the recommendation. Finally, CDC Director Dr. Rochelle Walenski will decide whether to accept or change the committee's recommendation.

As soon as Walenski approves, young children can immediately start getting vaccinated against COVID-19.

How well the vaccine works and how safe is it

Because children are not little adults, as many pediatricians like to say, the FDA needs to look at data from trials conducted specifically with children.

A child's body still develops and reacts differently to the vaccine than an adult, so as with any vaccine for children, scientists tested different doses to determine what the child's body can tolerate and what dose level would be protective. For young children, Pfizer has requested a 10 microgram dose authorization; the dose used for people 12 years and older is 30 mcg. The vaccine still requires two doses three weeks apart.

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Data released by Pfizer in September during Phase 2/3 trials showed that its COVID-19 vaccines produce a "sustained" antibody response in children aged 5 to 11 years. In a new document released ahead of the FDA meeting, Pfizer said its vaccine is safe and has a 90,7% efficacy of COVID-19 in children aged 5 to 11.

In this trial, which involved about 2000 children, there were three cases of COVID-19 in the vaccine group and 16 in the placebo group. During the trial, twice as many children received the vaccine as the placebo.

Pfizer said there were no serious side effects such as pericarditis, inflammation of the lining of the heart or myocarditis, inflammation of the heart muscle, while the participants were monitored for three months after the shots. These rare side effects have occurred in some adults and adolescents who received the vaccine. The size of the study was small enough that the researchers believe the problem is unlikely to show up among volunteers.

In an assessment, the FDA said the benefits of the Pfizer / BioNTech COVID-19 vaccine outweigh the risks for children aged 5 to 11 in the current pandemic. The FDA believes the vaccine carries a theoretical risk of myocarditis or pericarditis, which may require treatment and even hospitalization. But the risk of COVID-19 is higher if enough virus is circulating.

“This is a really high level of effectiveness,” said Dr. Ashish Jha, dean of the Brown University School of Public Health.

Why is a baby vaccine needed?

Since the start of the pandemic, nearly 6,2 million children have tested positive for COVID-19. While there has been a recent downward trend in incidence, according to the American Academy of Pediatrics, nearly 131 more children were diagnosed with COVID-000 in the last week alone.

Severe illness among children is rare, accounting for less than 5% of hospitalizations and less than 0,025% of deaths. But according to the CDC, 637 children have died from COVID-19. In the first half of this year, this disease was one of the ten leading causes of death in children aged 5 to 14 years.

“COVID-19 has not spared children, even though they tolerate the disease better than adults. There have been hundreds of children who have lost their lives and thousands who have been hospitalized and had their lives disrupted by COVID-19,” said US Surgeon General Dr. Vivek Murthy. “We want to protect our children.” We want them to get their lives back."

For pediatricians and many anxious parents, vaccines may take a while.

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“Here in Ohio, I think the number of COVID-19 cases in children has finally stabilized a little bit. Our offices have been very overwhelmed lately with COVID-19 testing,” said Dr. Claudia Hoyen, director of the Division of Children's Disease Control. “Hopefully this will calm down in time to start getting more vaccinations, because clearly we need them.”

Where can children be vaccinated?

Even before formal negotiations with the FDA and CDC took place, the administration of US President Joe Biden spent several months working on the logistics of a vaccine for children.

The Biden administration said it was contracted to supply enough vaccine to vaccinate 28 million eligible children.

There will be fewer mass vaccination sites. Pediatricians say long lines are not suitable for babies and crying can be contagious. Thus, the focus will be on the places where children usually go for medical care and where parents can ask questions from a reliable medical source.

“Children have different needs than adults, and our operational planning is designed to meet those specific needs, including by offering vaccinations in settings that parents and children know and trust,” said the White House COVID Response Coordinator. -19 Jeff Zients.

The Biden administration has coordinated with more than 25 doctors' offices, community health centers and rural clinics, as well as thousands of pharmacies. The administration has partnered with the Children's Hospital Association and is working with hundreds of school clinics.

The baby version of the vaccine will be packaged in smaller vials that can be stored (up to 10 weeks) in the refrigerator at the doctor's office

At the local level, doctors planned to vaccinate children for several months.

The UH Rainbow Babies and Children's Hospital system has worked hard to make sure all of their pediatricians received their licenses and required items. The health system printed leaflets and planned outreach activities. They will also have a few larger vaccination points in case the children do not have a permanent pediatrician or their doctor is not in the mood for vaccinations.

Will parents vaccinate their children?

It is not yet clear how many parents will take their children for vaccination.

A recent Kaiser Family Foundation poll in September found that about a third of parents with children of this age will want to wait and see before giving their child the COVID-19 vaccine. About a third said they would immediately vaccinate their babies.

If the number of teenagers is any indication, vaccinating children may be slow. Teens are the age group that has been vaccinated the least among those already eligible.

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Although the vaccine is believed to be 93% effective in preventing hospitalization due to COVID-19 among children ages 12 to 18, according to the CDC, currently only 46% of children ages 12 to 15 and 54% are 16 to 17 year olds are fully vaccinated. Still, the Biden administration is optimistic.

“I hope the vast majority of parents understand the real benefits of vaccinating their children,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Claudia Hoyen expressed hope that parents will understand: not only masks, but also a vaccine is one of the ways to let children go to school. This will help protect them in the future. Lately, she says, she has treated many more children with long-term COVID-19 symptoms. Even in children who initially had mild cases of the disease, symptoms appear months later.

“These vaccines are safe, they are effective,” Hoyen said. “As we head into the holiday season and want to be together with friends and family, it would be a really nice holiday gift for all of us if everyone, including children, got vaccinated as soon as vaccines become available.”

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