A new study involving more than 2,000 adolescents, from ages 12-15, shows that the Pfizer and BioNTech-developed vaccine is effective and well-tolerated for that age group, meaning that it could be utilized to protect kids from COVID-19.
According to CNN, Pfizer plans to submit data from its Phase 3 clinical study to the U.S. Food and Drug Administration to expand its emergency use authorization of the two-dose vaccine to that younger age group.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12-15,” said Pfizer CEO Albert Bourla. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
While trial data has not yet been peer-reviewed, the Pfizer-reported results are very encouraging. Out of the 1,131 kids inoculated with the Pfizer vaccine, not one contracted COVID-19, compared to 18 of the 1,129 who received a placebo.
The study showed that side effects of the vaccine are similar to what people aged 16-25 experience, including pain at the injection site, fatigue, and fever. The study subjects will be monitored for a two-year period as part of the study, to gauge any possible long-term effects.
“This is exactly the news that we hoped to hear,” Dr. Buddy Creech, a pediatric infectious disease expert at the Vanderbilt University Medical Center, told NBC News.
An article from Time on the study results noted that the antibody levels for the study subjects actually exceeded the levels of those from 16-25 in the original Pfizer/BioNTech trial.
“So far, experts say children don’t seem to be affected by the virus as severely as older adults,” Time’s Alice Park observed, “although protecting them from symptoms of the disease is critical, not least as an additional way to curb spread of the virus. In a recent study of adults published by the U.S. Centers for Disease Control, scientists found that the mRNA-based vaccine not only protects against symptoms of the disease, but can ward off infection with the virus in the first place”
“The adolescent study wasn’t designed to confirm this in the younger population as well,” she added, “but given younger people’s more responsive immune systems, it’s likely they might benefit from the same protection from infection.”
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