In the United States, some 28 million children between the ages of 5 and 11 may soon be eligible for the Covid-19 vaccine, and plans are already underway to help them get it.
The U.S. Food and Drug Administration’s independent vaccine advisory board will meet on Tuesday to determine whether Pfizer and BioNTech’s Covid-19 vaccine should be authorized for young children. If licensed, it would become the first vaccine available for young children. Pfizer’s vaccine is already licensed for children 12 to 15 years old and is approved for people 16 years of age and older.
If the FDA committee votes in favor, then the FDA will make the final decision on whether to approve it.
Then, the independent advisory committee of the U.S. Centers for Disease Control and Prevention will meet on November 2-3 and vote on whether to recommend it. Finally, the director of the CDC, Dr. Rochelle Walensky, will decide whether to accept or modify the committee’s recommendation.
Once Walensky is disconnected, young children could start receiving Covid-19 vaccines immediately.
How well does the vaccine work and is it safe?
Since children are not little adults, as many pediatricians like to say, the FDA must review data from trials conducted specifically with children.
Children’s bodies are still developing and reacting differently to a vaccine than an adult’s, so as with any vaccine for children, scientists tested different doses to find out what a child’s body can tolerate and at what level. of dose would be protective. For young children, Pfizer has sought approval for a dose of 10 micrograms; doses used in people 12 years of age and older are 30 micrograms. The vaccine still requires two doses given three weeks apart.
In this trial, which involved around 2,000 children, there were three cases of Covid-19 among the group that received the vaccine and 16 in the placebo group. In the trial, twice as many children received the vaccine as the placebo.
Pfizer reported that there were no serious side effects like pericarditis, inflammation of the lining around the heart or myocarditis, inflammation of the heart muscle, while participants were monitored within three months of treatment. injections. These rare side effects have happened in some adults and older adolescents who have received the vaccine. The size of the study was small enough that scientists say the problem is unlikely to manifest among volunteers.
In an assessment released Friday evening, the FDA said the benefits of Pfizer / BioNTech’s Covid-19 vaccine outweigh the risks for children aged 5 to 11 under current pandemic conditions. The FDA has said the vaccine carries a theoretical risk of myocarditis or pericarditis that could require treatment and even hospitalization. But the risk of Covid-19 is higher if enough viruses are circulating.
“It’s a very high level of effectiveness,” said Dr Ashish Jha, Dean of Brown University School of Public Health. “This is the kind of thing we saw at the start of Pfizer, before the Delta variant and other worrisome variants went into effect, so I thought it was pretty convincing.”
Why a vaccine for children is needed.
Nearly 6.2 million children have tested positive for Covid-19 since the start of the pandemic. While cases have tended to decline recently, just last week around 131,000 more children were diagnosed with Covid-19, according to the American Academy of Pediatrics.
Serious illnesses are rare in children – they account for less than 5% of hospitalizations and less than 0.025% of deaths – but there have been 637 children who have died from Covid-19, according to the CDC. Covid-19 was among the top 10 causes of death in children aged 5 to 14 in the first half of this year.
“Covid has not been mild in children even though they are doing better than older adults, we have had hundreds of children who have lost their lives, thousands who have been hospitalized and whose lives have been lost. disturbed because of Covid-19, “US Surgeon General Dr Vivek Murthy told CNN. “We want to protect our children. We want them to be restored to life.”
For pediatricians and many anxious parents, vaccines can’t come soon enough.
“Here in Ohio, I think our pediatric Covid cases have finally plateaued a bit, but our offices have been so overwhelmed with testing for Covid recently,” said Dr Claudia Hoyen, director of pediatric infection control. with UH Rainbow Babies and Children’s Hospital. “Hopefully it calms down just in time to start distributing the new shots… because we clearly really need them.”
Where can children get vaccinated?
Even before official conversations at the FDA and CDC took place, the Biden administration has been working on vaccine logistics around children for months.
The Biden administration said it is committed to securing sufficient supplies to immunize the 28 million eligible children.
There will be fewer mass vaccination sites like the United States used with adult vaccines. Pediatricians say long lines are not suitable for children and crying can be contagious. Thus, the focus will be on places where children usually go for treatment and also where parents can ask questions of a trusted medical source.
“Children have different needs than adults and our operational planning is designed to meet those specific needs, including delivering immunizations in environments that parents and children know and trust,” said Wednesday. White House Covid-19 Response Coordinator Jeff Zients.
The Biden administration has coordinated with more than 25,000 doctor’s offices, community health centers and rural health clinics, as well as thousands of pharmacies. The administration has started a partnership with the Children’s Hospital Association and works with hundreds of school clinics.
The hope is to make it as easy as possible for children to get these vaccines.
This version of the vaccine will also be packaged in smaller configurations that can be stored in the type of refrigerator that a doctor’s office would have.
Child-sized vials can also be stored for up to 10 weeks.
At the local level, doctors’ offices have also been planning to vaccinate children for months.
In the UH Rainbow Babies and Children’s Hospital system, Hoyen said they’ve worked hard to make sure all of their pediatric practices get their licenses and the shipments they need. The health system has printed leaflets and awareness-raising efforts are planned. They will also have a few larger vaccination sites in case the children do not have a regular pediatrician or their doctor is not set up to do the vaccines.
“For us it’s going to be pretty routine and I think that’s what the administration was hoping for,” Hoyen said. “It will be operational and when the children come for their visit in good health, they will also be able to be vaccinated against Covid.”
Will parents get their children vaccinated?
It is still not clear how many parents will take their children to be vaccinated.
A recent Kaiser Family Foundation survey in September found that about a third of parents with children in this age group would like to wait and see before getting their child vaccinated against Covid-19. About a third said they would get their young children immunized immediately.
If the number of adolescents is any indication, immunizations for children may progress slowly. Adolescents and pre-adolescents are the least vaccinated age groups among those already eligible.
Although considered 93% effective in preventing hospitalizations due to Covid-19 in children aged 12 to 18, currently only 46% of children aged 12 to 15 and 54% of those aged 16 to 17 years are fully vaccinated, according to CDC data. Still, the Biden administration is optimistic.
“I hope the vast majority of parents realize the real benefit for children from getting vaccinated,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, CNN’s Chris Cuomo told CNN on Wednesday.
Hoyen said she hopes parents understand that in addition to masks, a vaccine is a way to keep children in school. It can also protect them for the future. Lately, she said, she has treated many more children with long symptoms of Covid. Even children who had mild cases initially face symptoms months later.
“These vaccines are safe, they are effective,” Hoyen said. “As we move into the holiday season and want to be with our friends and family, it would be a really nice holiday gift for all of us if everyone, including the kids, got vaccinated once these vaccines would be available. “
™ & © 2021 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.