21 days gap for 5 to 11 year old children was well tolerated. The vaccine’s side effects were similar in most cases to those seen in individuals between the ages of 16 and 25. The vaccination dose utilized in this experiment was 10 micrograms, which is less than the 30 microgram dose recommended for individuals aged 12 and above. For safety and efficacy in young children, this dosage was chosen as the preferred dose.
Albert Bourla, the chairman and CEO of Pfizer, spoke about the need to vaccinate children. He said, “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency”.
Bourla added, “Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. 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”.
Despite the promising results, the public will have to wait a while until vaccinations for children under 12 are officially launched. Pfizer and BioNTech will submit the findings of the trials to the Food and Drug Administration for assessment and possible approval following the completion of the analysis. This will probably take a few months. According to Dr. Francis Collins, director of the National Institutes of Health, parents and caregivers may have to wait until the end of 2021 for a complete approval of the COVID-19 vaccine for young children aged 5 to 11.
According to the pharmaceutical firms, the findings of the trials for youngsters under the age of five might be released later this year. Pfizer and BioNtech are planning to submit the trial’s findings to regulatory authorities as soon as possible. Ugur Sahin, CEO and co-founder of BioNTech, spoke about the company’s goal towards vaccinating children. He said, “Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for schoolkids to regulatory authorities around the world before the winter season begins”.
