What about vaccines for children under the age of 5?

Keeping young children safe was an exhausting exercise for parents during the coronavirus pandemic. Dr. Langlois, a pediatrician at the University of Michigan Health CS Mott Children’s Hospital, who has two young children, one of whom is under the age of five, says that many parents will vaccinate their little children. He said he was eager.

Their last-minute waffles only increased the mental fatigue of their parents when the Food and Drug Administration appeared to be approaching approval for two shots for infants. Here’s how to understand what happened and what it means for your family.

What’s happening

Earlier in the month, the FDA announced that a panel of independent health professionals would be convened on February 15 to decide whether to administer two doses of Pfizer-BioNTech. COVID-19 Vaccines are safe and effective for children from 6 months to 4 years old. However, in a very unusual move, the agency said it would cancel the meeting a few days before it was scheduled and wait for data to be evaluated from three doses instead of two, which was not expected until April at the earliest. Did.

The pivot was particularly confusing as the FDA pressured Pfizer-BioNTech to begin a double-dose review of the vaccine, despite disappointing results from the December clinical trial. It seems to protect people from 6 months to 2 years old). Since December, Pfizer and BioNTech have stated that children under the age of five will probably need three vaccinations, each of which is only one-tenth the dose received by children over the age of 12.

FDA regulators may have hoped that young children could be vaccinated sooner or later by initiating a double-dose approval process before triple-dose study data became available. .. And if new data collected after December show that the vaccine protected children from symptomatic treatment or severe illness, Omicron The surge, which may have given regulators more information to work in vaccine reviews for children under the age of five.

However, Dr. Palmer said: “From Friday’s announcement, the data probably wasn’t as rosy as they wanted.”

What this means for the family

The delay is disappointing, but it is important for regulators to take the time to ensure that the vaccine properly protects infants without compromising safety and efficacy.

Dr. Ofer Levy, director of the Boston Children’s Hospital Precision Vaccine Program and a member of the FDA’s Vaccine Advisory Board, said: But “it’s also important to sympathize with the FDA people. They are in a difficult situation. At the same time, they are criticized for moving too fast or too slow.”

“We can’t rush safety,” said Dr. Yvonne Maldonado, a pediatric infectious disease doctor who oversees the Pfizer-BioNTech trial at Stanford University. She said that one or two doses may not be enough to boost immunity. “It’s not that the first dose doesn’t work. It may take one or more doses to ensure a higher level of protection, so the test will take longer.”

According to Dr. Maldonado, it is actually quite common for young children to need multiple vaccinations to get a sufficiently large benefit. Hepatitis B vaccine is given to children in 3 doses, while diphtheria, tetanus and whooping cough (DTaP) vaccines usually require 5 doses.

Some parents are wondering. If the double-dose regimen was effective for children between the ages of 6 months and 2 years, why couldn’t the FDA approve the vaccine only for that age group? Unfortunately, “it doesn’t work that way,” Dr. Levy said. You can’t just look at the results after the fact and say, “Oh, what do you know?” Change your mind about how you are analyzing this. You just need to approve this subgroup, just to separate the groups. “

For similar reasons, parents cannot go to a child’s pediatrician to request a low dose of the vaccine before it is approved, Dr. Levy said. Vaccine dosages have been carefully reviewed and approved based on the risks and benefits of each age group.

Fortunately, once a vaccine for children under the age of 5 is approved, the pediatrician’s clinic is already set up to be vaccinated and managed, so deployment is much more than for adults. It should be faster. “I think we’re seeing the end of spring at this point,” she said.

And there’s still a lot we can do now to protect and prepare our families. If your child is afraid of needles, teach relaxation techniques or read related books to start preparing needles. If you have any concerns about how the Covid-19 vaccine fits your child’s usual injection schedule, or if you have questions about potential side effects, talk to your pediatrician, Dr. Langlois said. ..

And we will continue the following public health measures Avoid crowds If possible, mask and vaccinate older children. According to data from the Centers for Disease Control and Prevention, only 24% of ages 5-11 and 57% of ages 12-17 are fully vaccinated.

Coronavirus still causes illness in infants and disrupts their lives, Dr. Langlois said, but parents should not give up hope. “We’re going to get there,” she said. “Parents, including myself, need to be a little more patient.”