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US to inoculate younger children soon

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Some 28 million children ages 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 it.

The US Food and Drug Administration’s independent vaccine advisory board will meet Tuesday to discuss whether Pfizer and BioNTech’s Covid-19 vaccine should be authorized for younger kids. If authorized, it would become the first vaccine available for younger children. Pfizer’s vaccine is already authorized for children 12 to 15 and is approved for people age 16 and older.

If the FDA committee votes in its favor, the FDA will then make the final decision about whether to authorize it.

Then, the US Centers for Disease Control and Prevention independent advisory committee meets November 2 and 3, and will vote on whether to recommend it. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee’s recommendation.

Once Walensky signs off, younger children could start getting Covid-19 shots immediately.

How well does the vaccine work and is it safe?

Since children are not small adults, as many pediatricians like to say, the FDA needs to examine data from trials done specifically with children.

Children’s bodies are still developing and react differently to a vaccine than an adult would, so as with any vaccine for kids, scientist tested different doses to determine what a child’s body can tolerate and what dose level would be protective. For younger children, Pfizer requested authorization for a 10-microgram dose; the doses used in people 12 years and older is 30 micrograms. The vaccine still requires two doses given three weeks apart.

Data Pfizer submitted in September from a Phase 2/3 trial showed its Covid-19 vaccines generated a “robust” antibody response in children ages 5 to 11. In a new document posted ahead of the FDA meeting, Pfizer said its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.

In that trial,which involved around 2,000 children, there were three cases of Covid-19 among the group that got the vaccine and 16 in the placebo group. In the trial, twice as many kids got the vaccine as the placebo.

Pfizer reported that there were no serious side effects like pericarditis, inflammation of the lining around the heart, or myocarditits, inflammation of the heart muscle, while participants were being monitored in the three months after the shots. These rare side effects have shown up in some adults and older teens who got the vaccine. The study size was small enough that scientists say it is unlikely the problem would show among the volunteers.

In an assessment posted late Friday night, the FDA said the benefits of Pfizer/BioNTech’s Covid-19 vaccine outweigh the risks to children ages 5 to 11 under current pandemic conditions. The FDA 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 virus is circulating.

“It’s a really high level of efficacy,” said Dr. Ashish Jha, the dean of the Brown University School of Public Health. “This is the kind of stuff we saw early days of Pfizer, before the Delta variant and other variants of concern came into effect, so I thought that was pretty compelling.”

Nearly 6.2 million children have tested positive for Covid-19 since the start of the pandemic. While cases have been trending downward recently, this past week alone about 131,000 more children were diagnosed with Covid-19, according to the American Academy of Pediatrics.

Severe illness is rare among children — they make up 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 for children 5 to 14 years of age in the first half of this year.

“Covid has not been benign among children even though they do better than older adults, we’ve had hundreds of children who have lost their lives, thousands who have been hospitalized and whose lives have been disrupted because of Covid-19,” said US Surgeon General Dr. Vivek Murthy told CNN. “We want to protect our kids. We want them to get their lives back.”

To pediatricians and many anxious parents, the vaccines can’t come soon enough.

“Here in Ohio, I think our pediatric Covid cases have finally plateaued a little 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 that will quiet down just in time to start giving out the new shots … because clearly we really need them.”


Monday, October 25, 2021 – 01:00

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