Pfizer and BioNTech have unveiled positive results from their trial conducted on children aged 5 to 11. Their COVID-19 vaccine is "safe," eliciting a "robust" immune response and is "well-tolerated," they stated in a press release.
Those aged 12 to 17 have been eligible for the COVID-19 vaccine since June 15. Currently, 69% of this age group has received a first dose. With the spread of the Delta variant, a question arises: should children under 12 be vaccinated? While the benefits of the Covid-19 vaccine for younger children are still debated, Pfizer and BioNTech have just announced that their vaccine is "safe" for children aged 5 to 11.
Pfizer: a "robust" immune response and a "well-tolerated" vaccine
Pfizer and BioNTech unveiled, in a press release published on September 20, the "positive results" of their trial conducted on 2,268 children aged 5 to 11. Participants received two 10-microgram injections of the vaccine, 21 days apart. As a reminder, for those over 12, the dose administered is 30 micrograms.
The results indicate that their Covid-19 vaccine is "safe," eliciting a "robust" immune response and is "well-tolerated." The immune response obtained is also “comparable” to that observed in volunteers aged 16 to 25, who made up the control group in this trial, according to Pfizer and BioNTech. The same is true for the side effects, which were also comparable to those identified in the 16-25 year olds.
Faced with 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 Pfizer Chairman and CEO Albert Bourla emphasized.
This is why the companies indicated that they planned to submit these findings “as soon as possible” to the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies. They also specified that they expected results in children under 5 years old “by the end of the year.” COVID-19 Vaccine: Are Children at Higher Risk with the Delta Variant?
The question of vaccinating children under 12 is being raised, in particular, because of the spread of coronavirus variants. "We are monitoring the spread of the Delta variant and the substantial threat it poses to children," stated Albert Bourla.
During August, American health professionals warned of an increase in hospitalizations due to the Delta variant among children. 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 due to 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, specifying that hospitalization rates were 10 times higher among unvaccinated children and adolescents than among those who had completed their vaccination schedule. However, vaccination of children under 12 is not yet underway in the United States. What about France? The President of the Republic addressed the issue at the beginning of September. "Some countries have opened it up to children under 12, but we are following the advice of those who are well-informed, and for the moment we are continuing with those over 12." And then there are people who are worried, we have to listen to all of that (…) As soon as the scientists tell us: ‘We open it up to younger people’, we will do it,” Emmanuel Macron had stated.
