The results indicate that their COVID-19 vaccine is safe, as it generates a robust and well-tolerated immune response. According to Pfizer and BioNTech, the immune response obtained is comparable to that observed in volunteers aged 16 to 25 who comprised the control group in this trial. The same is true for side effects, which were also comparable to those identified in the 16-to-25-year-old group.
Given these encouraging results, Pfizer and BioNTech stated that they were “eager to extend the protection offered by the vaccine to this younger population, subject to obtaining regulatory approval,” as emphasized by Pfizer’s Chairman and CEO, Albert Bourla.
Therefore, the laboratories indicated that they planned to present these findings to the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies “as soon as possible.” They also specified that they expected to obtain results in children under 5 years of age “by the end of the year.”
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