Pfizer and BioNTech have presented positive results from their clinical trial in children between the ages of 5 and 11. Their COVID-19 vaccine is “safe,” elicits a “robust” immune response, and is “well-tolerated,” according to a press release.
People between the ages of 12 and 17 have been able to receive the COVID-19 vaccine since June 15. Currently, 69% of this age group has received their first dose. With the spread of the Delta variant, the question arises: should children under 12 be vaccinated? While the benefits of the COVID-19 vaccine for younger children are still being debated, Pfizer and BioNTech have just announced that their vaccine is safe for children between the ages of 5 and 11.
Pfizer states that the vaccine offers a robust immune response and is well-tolerated.
Pfizer and BioNTech announced, in a press release published on September 20, the positive results of their clinical trial conducted with 2,268 children between the ages of 5 and 11. Participants received two 10-microgram doses of the vaccine, 21 days apart. It is worth noting that the dose for children over 12 years of age is 30 micrograms.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.”
COVID-19 vaccine: Are children at greater risk with the Delta variantThe question of vaccinating children under 12 is being raised, particularly due to the spread of coronavirus variants. “We are monitoring the spread of the Delta variant and the significant threat it poses to children,” stated Albert Bourla.
During August, US health professionals warned of a surge in hospitalizations due to the Delta variant in children. However, data released in early September by the US Centers for Disease Control and Prevention (CDC) revealed that while hospitalizations among children and adolescents had increased fivefold between late June and mid-August, the proportion of young people hospitalized for severe illness remained unchanged during the period when the Delta variant was predominant. The CDC also highlighted the effectiveness of the COVID-19 vaccine in young people, noting that hospitalization rates were 10 times higher among unvaccinated children and adolescents than among those who had completed the full vaccination schedule. Nevertheless, vaccination of children under 12 is still not underway in the United States. What about France? The President of the Republic addressed the issue in early September. “Some countries have opened their doors to children under 12, but we follow the advice of experts and, for the moment, continue with those over 12. There are those who are concerned, and we must listen to their concerns (…) As soon as the scientists tell us: ‘We can open the doors to younger children,’ we will,” declared Emmanuel Macron.
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