Pfizer and BioNTech have unveiled the positive results of their trial conducted on children aged 5 to 11. Their vaccine against Covid-19 is "safe", at the origin of a "robust" and "well-tolerated" immune response, they say in a statement.
12-17 year olds have been able to benefit from the Covid-19 vaccine since June 15. For the time being, 69% of this category of the population has received a first injection. Faced with the spread of the Delta variant, a question arises: will children under 12 years old have to be vaccinated? While the benefits of the anti-Covid vaccine in the youngest 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
The Pfizer and BioNTech laboratories unveiled, through a press release published on September 20, the "positive results" of their trial conducted on 2,268 children aged 5 to 11 years. Participants received two vaccine injections dosed at 10 micrograms 21 days apart. As a reminder, in those over 12 years old, the injected dose is 30 micrograms.
The results indicate that their Covid-19 vaccine is "safe", causing a "robust" and "well-tolerated" immune response. The immune response obtained is also "comparable" to that observed in volunteers aged 16 to 25, who made up the control group during this trial, say Pfizer and BioNTech. The same is true with the side effects, which were also comparable to those identified in 16-25 year olds.
Faced with these encouraging results, Pfizer and BioNTech said 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 pointed out.
For this reason, the companies have indicated that they plan to submit these findings to the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies "as soon as possible". They also said that they expected results in children under 5 years old "as soon as the end of the year".
Covid-19 vaccine: children more at risk from the Delta variant?
If the question of vaccinating children under 12 years of age arises, it is 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," Albert Bourla said.
During the month of August, American health professionals had warned of an increase 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 had increased fivefold among children and adolescents between the end of June and mid-August, the proportion of young people hospitalized because of a severe form of the disease had not changed during the period when the Delta variant was predominant. The CDC had also highlighted the effectiveness of the Covid vaccine in young people, saying that hospitalization rates were 10 times higher in unvaccinated children and adolescents than in those with a complete vaccination pattern. However, the vaccination of children under 12 is not yet on the agenda in the United States. What about France? The President of the Republic had spoken on the subject at the beginning of September. "Some countries have opened it up to children under 12 years old, but we follow people who know and for the moment we are continuing with those over 12 years old. And then there are people who are worried, we have to listen to all this (...) As soon as scientists tell us: 'We open it up to the youngest', we will do it," said Emmanuel Macron.
The results indicate that their Covid-19 vaccine is "safe", causing a "robust" and "well-tolerated" immune response. The immune response obtained is also "comparable" to that observed in volunteers aged 16 to 25, who made up the control group during this trial, say Pfizer and BioNTech. The same is true with the side effects, which were also comparable to those identified in 16-25 year olds.
Faced with these encouraging results, Pfizer and BioNTech said 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 pointed out.
For this reason, the companies have indicated that they plan to submit these findings to the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies "as soon as possible". They also said that they expected results in children under 5 years old "as soon as the end of the year".
Covid-19 vaccine: children more at risk from the Delta variant?
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