Parents have a reason to worry. After months of declining cases, the virus finds the unvaccinated.
Adolescents up to 12 years of age can be vaccinated against COVID-19, but younger children are not yet eligible.
Children accounted for more than a quarter of the cases reported during the week ending Sept. 2. “After declining in early summer, pediatric cases have increased exponentially, with more than 750,000 cases added between Aug. 5 and Sept. 2,” the American Academy of Pediatrics said. Tuesday. The most recent weekly number of cases marks an increase of 250% from the week of July 22 to 29, when the AAP counted 71,726 new cases in children.
Children have been largely spared the worst of COVID-19: hospitalizations and deaths are rarer for children than for adults, although children’s hospitals are filled with COVID-19 hotspots throughout. the country.
MORE: COVID-19 cases in children reach levels not seen since the winter increase
The childhood vaccine may not arrive soon enough, but the process takes longer than initially expected.
“We really hoped we might have something in place before we try to get the kids back into the school classroom, but unfortunately we weren’t able to do that,” said Dr. Emily Chapman, vice president. chief physician of Children’s Minnesota.
Chronology of COVID-19 vaccines for younger children
Test data for COVID-19 vaccines for younger children are still being collected. Once vaccination companies obtain test results, they must submit the information to the U.S. Food and Drug Administration, which will evaluate the vaccines for authorization.
Dr. Scott Gottlieb, a former FDA commissioner who is now on the board of vaccine maker COVID-19 Pfizer, told CBS’s Face the Nation earlier this month that the company is likely to be able to file the data during 5-11 year olds – Authorization is requested “sometime in September” and then submits the application for emergency use of the vaccine “potentially already in October”.
“This will put us in a period of time when vaccines could be available sometime in late fall, probably early winter, depending on how long it takes the FDA to review the application,” Gottlieb said.
There is no official schedule once a company is presented to the FDA. Considerations for emergency use can take several weeks.
“There’s always something that makes things not the way we think,” said Dr. Stanley Perlman, who is on the FDA’s advisory committee on vaccines and related biological products and is also a pediatrician and professor of microbiology and immunology at the University of Iowa Health Care. “Obviously, we want it done as soon as possible, but we want it done right.”
When asked earlier this month if a COVID-19 vaccine for young children would be authorized before Thanksgiving, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases , told CNN’s Wolf Blitzer he hopes so, but doesn’t want to get ahead of the FDA.
“They should get the data, at least in one of the companies, by the end of September,” Fauci noted.
“The data will then be submitted to the FDA and the FDA will determine whether to grant this authorization under an emergency use authorization or some other mechanism.”
CDC director Dr. Rochelle Walensky said during a City Council meeting of the National Association of Parents and Teachers earlier this month that she expects the Pfizer vaccine to be available for children in 2021.
“Everyone is looking at it urgently. Everyone recognizes the importance of these children having access to vaccines,” he said when asked about the schedule. “My understanding of the timeline is pretty consistent with what’s being said: Mid-Autumn is what I understand, early fall is when we anticipate seeing the data and then it will be in the hands of the FDA. “And I’m hopeful for the end of the year.”
Data for children aged 2 to 5 could arrive shortly after data for older children. For younger children, Pfizer told CNN it could have enough research for October or November and soon after asking the FDA to authorize emergency use.
Moderna’s trial is underway, but it’s a few months away from Pfizer. Johnson & Johnson does not expect its multiple trials in children to begin until the fall.
Why a vaccine for younger children takes longer
Hundreds of millions of adults have been vaccinated, proving that COVID-19 vaccines are safe and effective, but these results are no substitute for the necessary research in children.
“As much as we would like to go ahead and start vaccinating our children now, it’s very important that we take that time to make sure science is rigorous,” said Chapman of Minnesota.
For the pediatric version of the COVID-19 vaccine, the scientists used the results of the adult trials and a full pediatric trial.
Having adult research speeds up the process. For people as young as 12, Perlman explains, companies did not have to register the 30,000 people they needed for adult testing, as they could do what is called “immunobridging.” The data showed that for this age group, the immune response was equivalent to that of adults.
Companies take a similar approach with younger children, but in early August, the FDA requested six months of follow-up safety data, instead of the two months it requested with adults. He also called on Pfizer and Moderna to double the number of children aged 5 to 11 in clinical trials.
According to CDC vaccine advisors, in June there is a likely association between COVID-19 mRNA vaccines and extremely rare cases of heart inflammation in adolescents and young adults, but the benefits of vaccination still outweigh the risks. Cases of inflammation appeared to be mild and resolved quickly on their own or with minimal treatment.
At Texas Children’s Hospital, interim pediatrician James Versalovic said it was no problem hiring more children for Pfizer and Moderna trials. Many test sites have long waiting lists. The expansion of the trials, however, added at least one more month to the research process.
“We all agreed it was worth it, just to make the trials even more robust data to provide that extra level of peace of mind to parents across the country. It lengthens the trial, but only a little bit,” Versalovic said.
“Children are not small adults”
Childhood vaccine trials actually begin in adults.
“Normally, all vaccine candidates, even for other conditions, would be evaluated first in adult patients and then at progressively younger ages,” explained Dr. Kari Simonsen, who directs the trial. Pfizer vaccine at Children’s Hospital and Omaha Medical Center. . “We cannot make assumptions about the safety or tolerability of drugs in children that are the same as in adults,” he said.
It is because of biology.
“As we like to say in pediatrics: children are not young adults. Children are children,” Versalovic said. “Their bodies develop and will react differently, and we have to treat them differently.”
When it comes to the infant phase of the test, scientists make the best guess about which dose would be safe and would generate an immune response. Levels and time are based on stages of development.
“In general, our children have very active and sensitive immune systems, so we suspect that smaller doses of vaccine will elicit an adequate response in a child to successfully fight the infection,” Chapman said.
As with any vaccine test, it must go through a three-phase trial before the FDA can authorize it. Tests in the first phase to see if the vaccine is safe in about 20 to 100 healthy children.
Because these are accelerated trials, scientists have combined phases 2 and 3 of the trials to be able to take more steps in parallel, Versalovic said. At these stages, scientists monitor safety and test whether children’s immune systems respond to the vaccine. In this step, the scientist recruits hundreds or even thousands of children. Some are vaccinated, others have placebo and the results are compared.
Only after completing these steps can a company apply for authorization or approval from the FDA.
If the FDA signs it, the vaccine gets another set of expert eyes with the CDC Advisory Council on Immunization Practices. This committee also draws up a formal recommendation regarding the delivery, storage, timing, distribution and administration of the vaccine. The committee’s recommendation becomes official when the CDC director reviews and approves it.
In these intermediate months, according to experts, children can remain free of COVID-19. Adults, however, will have to help them.
“The best we can do for them is surround them with vaccinated adults,” Chapman said. “And surround them with people who mask and keep masks as much as possible.”
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