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Children as young as 5 years old could be vaccinated against COVID-19 by Halloween, now that Pfizer and BioTech report that lower doses of their vaccine have been shown to be safe while producing a “robust” antibody response in this group of people. ‘age.

The results announced by the companies earlier this week are yet to be submitted to the United States Food and Drug Administration, which will decide whether to change the emergency use order allowing teens ages 12 to 15 years to receive the vaccine to include children aged 5 to 11. .

While the data shared so far appears to be good news for parents concerned about protecting their young children from the deadly virus, experts are waiting to see details of the latest clinical trial that involved some 2,300 children aged 5 to 11. years.

“A press release is just a press release, and we want to see the rest of the data. But I hope that happens very soon, and I hope that a good close review of the data set will be just as encouraging as what they published in the press release, ”said Dr Andy Pavia to journalists in a recent virtual news. conference.

Pavia, chief of the division of pediatric infectious diseases at the University of Utah Health and director of hospital epidemiology at Intermountain Primary Children’s Hospital in Salt Lake City, said “this is really the point at which we can. say, “Yeah, that sounds awesome.” We are delighted to give it to our children.

How serious is COVID-19 for children?

Lately, there are typically eight to 10 children hospitalized in elementary school for children with COVID-19, Pavia said, “far more than we’ve seen at any time in the past year. I think this reflects both the spread among children that we are seeing this year and the increased infectivity of delta, ”the highly contagious viral variant.

School-aged children also account for about 1 in 4 new cases of the virus in Utah during the current outbreak, he said, a number likely higher because many parents do not test their children for the virus because that they are worried. having to prevent them from going to school.

There have been nearly 60,000 cases of the virus in Utahns aged 14 and under, representing 12% of all cases in the state, according to the Utah Department of Health. Nearly 500 have been sick enough to be hospitalized and two young people in Salt Lake County have died of the disease, including an unvaccinated teenager.

What parents should do

Deciding whether to vaccinate children against COVID-19 means assessing the risks involved, Pavie said. Children get sick enough to be hospitalized or die, but even in the mildest cases they miss school and face the possibility of dealing with what is known as the long COVID-19 – fatigue, fog and other persistent symptoms.

“You have to balance these risks, which people don’t always fully appreciate,” he said, with the potential risks of injections which, so far, “have been shown to be as safe as any vaccine like us. let’s use “. But Pavia said that in children aged 5 to 11, the study was not large enough to know what he called rarer side effects.

This information will come as the vaccine rolls out to the younger group, he said, adding that if his own children were 5 to 11, they would be on the front line for vaccines on day one. where they were available – if they had not already been enrolled in a clinical trial.

“What I would say is if your child goes to school in Utah, he’s at a pretty high risk of contracting COVID and a pretty high risk of complications,” Pavia warned. However, he said, “if they stay home, if they are in a state where there is universal masking and very low infection rates, their risk is lower.”

For low-risk children, the doctor said parents “might want to wait a little longer until we know more about rare or minor safety effects.” The best source of information for parents, Pavia said, is a family pediatrician or other health care provider.

The bottom line for him, however, is that the risk presented by COVID-19 is great while the risk of the vaccine “is almost certainly much, much smaller.”

Will the vaccine really be available by Halloween?

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to President Joe Biden, said there was a good chance the injections would be approved for children before they were go to therapy.

FDA officials pledged earlier this month to “carefully, thoroughly, and independently review the data to assess the benefits and risks and be ready to complete its review as quickly as possible, possibly within a few minutes. weeks rather than a few months ”.

But in the same statement, Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Peter Marks, director of the FDA’s Center for Biologics Assessment and Research, also said, “Like every vaccine decision that we took during this pandemic, our assessment of data on COVID-19 vaccine use in children will not cut corners. “

Pavie said that in the past, similar decisions were made within weeks of submitting the application, so late October or early November could be the date when clearance could be anticipated. But he also admitted that it was only a matter of “looking at a crystal ball”.

After FDA approval, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is to meet to develop clinical recommendations. It usually only takes a day or two.

And once the federal government gives the green light, Pavia said he expects injections to be given to children in the same places as teens, teens and adults, including doctors’ offices. , clinics and pharmacies.

Parents planning ahead for the holidays should realize that it takes five weeks from the first dose to be fully immunized. In addition to the three week wait between the two injections, it takes another two weeks after receiving the final dose before a person is considered fully immune to the virus.

How the vaccine was tested

The trial tested two doses of the vaccine given 21 days apart, the same regimen currently given to people 12 years of age and older, but the doses were one-third less than the standard 30 micrograms. However, the immune response generated seemed to be equivalent to larger doses in adolescents.

That’s all the companies had to show since vaccines had been shown to be effective in stopping COVID-19 infections in studies in older groups, including one trial in 44,000 adults, USA Today reported. Trials are currently underway for children 2 to 5 years old and 6 months to 2 years old.

Pfizer and BioTech said the children involved in the studies of the three age groups came from more than 90 locations in the United States, Finland, Poland and Spain, and some had already had COVID-19, according to USA Today .

The other two coronavirus vaccines approved for use in the United States, the two-dose Moderna and the single-dose Johnson & Johnson, are also under study in children. Pfizer’s injections are the only COVID-19 vaccine approved for adolescents and adolescents,

What about “off-label” clichés for children under 12 now?

This question arose last month, when the Pfizer vaccine was fully approved by the FDA, paving the way for prescribing “off-label” injections for different age groups, conditions or other indications than those stated by the manufacturers. authorities.

But experts say it’s not a good idea and have advised to wait until federal authorities have approved the safety concerns and looked into issues such as the proper dosage for young children. Pfizer shots are available under emergency use authorization for ages 12 to 16.

Utah Department of Health on COVID-19 Vaccines for Children

“There is a common misconception that children do not contract COVID-19 or are not at risk of serious illness from the virus. However, some children get sick enough to require hospital treatment. We still don’t know much about how COVID-19 will continue to impact children in the long term, ”the department said in a statement.

“COVID-19 is far more dangerous than any potential risk involved in getting a vaccine. Children suffer from serious and potentially long-lasting side effects at rates similar to those of adults, even if they have never had symptoms or had only mild symptoms at the time of their infection. Many children continue to suffer from fatigue, headaches, abdominal, muscle and joint pain, and difficulty remembering and processing information, ”the statement continued.

“The Utah Department of Health is eagerly awaiting further recommendations from the FDA and CDC to vaccinate children under 12 years of age. If you have young children, talk to your healthcare professional about the best ways to protect them until a vaccine is available.


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Mary Cashion

The author Mary Cashion