The European Medicines Agency (EMA) on Thursday gave the green light to immunization of children in Europe by approving the vaccine from Pfizer / BioNTech for 5 to 11 year olds.
After a final agreement from the European Commission, Member States who so wish will be able to start their campaign for children from December 20, the date on which the Pfizer laboratory said it was ready to deliver the pediatric formula of the Covid vaccine. -19.
Its protocol provides for two injections, containing one third of the adult dose (ie 10 mg of product), three weeks apart.
A single dose should be sufficient for children who have already been infected (which can be confirmed by serology).
Read also
Covid-19: why is there a fifth wave when the vast majority of us are vaccinated?
The Minister of Health, Olivier Véran, immediately reacted on Thursday during his press conference by indicating his intention to seize the National Consultative Ethics Council (CCNE) on the individual and collective benefits of child protection, as well as the High Authority for Health.
"In any case, if it were decided in France, this vaccination would not start before the beginning of the year 2022"
, he said.
At this point, the only data available comes from the clinical trial conducted by the Pfizer laboratory on 2,285 children in the United States, Spain, Finland and Poland.
Its results published in November in the
New England Journal of Medicine
show a good immune response against the Delta variant and an efficacy of 90% on symptomatic forms, comparable to that of young adults.
The most commonly observed side effects (injection site pain, fatigue, headache, fever, muscle pain) were generally mild or moderate, improving within a few days of vaccination.
A pending medical opinion
On the basis of this study, the EMA estimates that
"the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, especially in those whose state of health increases the risk of severe form"
. This finding also prompted the United States to authorize the pediatric formula of Comirnaty on October 29, just like Israel, more recently.
"The clinical trial in which 1,500 children received the vaccine does not, however, identify any rare side effects
," analyzes Professor Robert Cohen, pediatrician at the intercommunal hospital of Créteil.
This will require waiting for pharmacovigilance data collected from a larger number of children. We will have this information within a few weeks of vaccinating little Americans. ”
If they are in favor of the principle of vaccination, the learned societies of pediatrics and infectious diseases underline in an opinion published on November 15 that
"the urgency"
is not the same in France and in the United States.
“Six times as many deaths and twice as many hospitalizations in children have been recorded across the Atlantic, due to the obesity rate and the weight of minorities in the population,”
explains Professor Cohen.
American schoolchildren have also suffered four times more days of school closure than French children (with a psychological impact and disastrous learning).
Read also
Covid-19: the protein vaccine from Novavax should soon arrive in Europe
Chairman of the Vaccine Strategy Orientation Council, Professor Alain Fischer also believes that the French epidemic situation allows us to wait a little longer. However, if the feedback is good,
"our council will propose the recommendation of this vaccination in January"
, indicates the immunologist, who is not in favor of extending the health pass to children. He favors pedagogy with parents and recalls that more than 60 children under 9 are currently hospitalized for complications related to Covid. Another argument: the incidence rate in this age group is increasing rapidly. However, notes Professor Fischer,
"even if they are not the main vector of respiratory infection, we know that children transmit it"
.
/cloudfront-eu-central-1.images.arcpublishing.com/prisa/KMEYMJKESBAZBE4MRBAM4TGHIQ.jpg)
