Published 20 September, 2021
Basseterre
Buckie Got It, St. Kitts and Nevis News Source
A lower dose of the Pfizer-BioNTech coronavirus vaccine — one-third the amount given to adults and teens — is safe and triggered a robust immune response in children as young as 5 years old, the drug companies announced in a news release Monday.
The finding, eagerly anticipated by many parents and pediatricians, is a crucial step toward the two-shot coronavirus vaccine regimen becoming available for younger school-aged children, perhaps close to Halloween.
The highly transmissible delta variant has collided with school reopening to reveal why children could benefit from a vaccine. Nearly 30 percent of cases in the first week of September were among children, according to the American Academy of Pediatrics. Although children rarely suffer severe illness, when they do it can be devastating. A vaccine could protect against rare cases of severe illness, cut the risk of long-haul covid and tamp down outbreaks.
The companies still must prepare and submit the data to the Food and Drug Administration, a process they expect to complete by the end of September. Then, the full data — which is not yet published or peer reviewed — will be scrutinized by regulators to ascertain that the vaccine is safe and effective. That could take weeks or up to a month.
Sharon Nachman, a pediatric infectious-disease specialist at Stony Brook Medicine in New York, said a vaccine for children would be a “huge, huge step forward” and that she is “cautiously optimistic” about Monday’s announcement.
“As most physicians are, I’m very cautious when it comes to the health of children,” Nachman said. “I think it will be critical to have the data presented to a group of experts who are unbiased and have no conflicts of interest.”
Regulators have made clear they are working as fast as possible but also need to ensure the vaccine meets the highest standards — especially because a rare but concerning vaccine side effect of heart muscle inflammation has been identified, most frequently in younger males eligible for the vaccines. An FDA analysisestimated that among male 16-to-17-year-olds, the risk was close to 1 in 5,000.
“You need to do these kind of studies, and it’s going to be important to vaccinate children,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. He called the results — that the vaccine triggered a robust immune response in children — somewhat predictable but important.
With the school year in full swing and cases soaring among children, pediatricians have been inundated with requests to bend the rules and give children a shot now. The new data seems likely to intensify the pressure, even though the existing vaccine is triple the dose tested in the trial. Younger children’s immune systems are not the same as those of adults, and the companies tested and found a much smaller dose was safe and effective.
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https://www.washingtonpost.com/health/2021/09/20/covid-vaccine-for-children/
