MONDAY, Sept. 20, 2021 (HealthDay News) — A smaller dose of the Pfizer COVID-19 vaccine safely triggers a strong immune response in children as young as 5 years, the company announced Monday morning.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Pfizer Chairman and CEO Albert Bourla, Ph.D., said in a statement. “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children.”
The finding, which will likely come as welcome news to many parents and pediatricians, is a crucial step toward the Pfizer two-shot regimen becoming available for younger school-aged children as early as Halloween, The Washington Post reported. The pediatric dose used in the trial was one-third the strength of the adult shots.
With COVID-19 cases soaring among children as the school year gets underway, pediatricians have been flooded with requests to bend the rules and give children a shot now, The Post reported. The new data seem likely to intensify that pressure, even though the existing Pfizer vaccine is triple the dose tested in the trial.
“No one should really be freelancing — they should wait for the appropriate approval and recommendations to decide how best to manage their own children’s circumstances,” William Gruber, M.D., Pfizer senior vice president of vaccine clinical research and development, told The Post, explaining that younger children tend to have more “exuberant” immune responses to vaccines than older people do.
In July, the FDA asked Pfizer and Moderna to increase the size of their pediatric trials to ensure the safety data were robust, The Post reported. There were nearly 2,300 children between the ages of 5 and 11 years in the Pfizer trial, two-thirds of whom received the vaccine. The rest received saline shots. The results of the trial showed that children who received the vaccine had immune responses similar to those seen in teens and young adults, according to Pfizer. Two shots of a 10-mcg dose, spaced three weeks apart, were well tolerated.
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