Agenda, dosage, efficacy, safety… What do we know about the vaccine for children?

After the green light from the High Authority for Health last week, Jean Castex announced this Monday evening that children aged 5 to 11 at risk will be able to be vaccinated from December 15 against Covid-19. “We have all the green lights to open vaccination to children aged 5 to 11 at risk, that is to say who suffer from obesity, respiratory diseases, heart,” said Olivier Véran.

In addition, the Prime Minister plans to open vaccination every 5-11 years, “if possible by the end of the year”, specifying that it would be done on a voluntary basis. The opportunity to review what we know about this pediatric vaccine.

What vaccine will be injected into children?

For the moment, only the vaccine developed by Pfizer / BioNTech is authorized in Europe.

Serum Moderna for children, it is the subject of an evaluation by the European Medicines Agency. His opinion is expected at the end of December. May since the
High Authority of Health has advised against the use of Moderna for children under 30 in France, Pfizer will most likely remain the only one injected into children.

When will this vaccination take place?

According to the Ministry of Health, France should receive “1.9 million pediatric doses on December 13, which will allow the campaign to begin”. Olivier Véran assured this Monday evening that the vaccination of vulnerable children could begin 48 hours later, that is to say on December 15. What about other children aged 5 to 11? Vaccination could begin on December 20 in vaccination centers and December 27 in cities.

“I put a reservation: we have a favorable opinion from the Steering Committee for Alain Fischer’s vaccination strategy, we are awaiting the green lights from the HAS and the National Consultative Ethics Committee (CCNE)”, qualified Olivier Véran . When contacted, CCNE told us that “for the moment, there is no fixed date yet, the working group is beginning its reflections”.

Is Pfizer vaccine for children the same as for adults?

Yes, it is the same product. On the other hand, it is less dosed. It indeed contains “10 micrograms of Pfizer instead of 30 [pour les adultes] “, Underlined Alain Fischer, chairman of the Steering Committee for the anti-Covid-19 vaccine strategy,
on LCI.

How effective is this vaccine?

According to a double-blind study (neither caregivers nor patients knew who was getting the vaccine or the placebo) published on November 9 in The News england journal of medicine, “Administration of the vaccine with two doses of 10 milligrams 21 days apart has been shown to be safe, well tolerated and effective in children 5 to 11 years old.”

After a first phase to determine the correct dose to be injected, the phase 2 and 3 trial concerned 2,268 children: 1,517 received a Pfizer vaccine and 751 a placebo. “Symptomatic infection more than seven days after second dose occurred in three vaccine recipients and in sixteen children who received placebo, complete Frédéric Rieux-Laucat, research director on pediatric autoimmune diseases and team leader at the
‘Imagine Institute. The study, carried out on a limited sample, therefore concludes with an effectiveness between 90 and 96%, as in adults. “

What side effects have been identified?

The European Medicines Agency approved this serum developed by Pfizer on November 25. “The side effects, which can last a few days, were rated as ‘mild or moderate’ and may manifest as localized pain at the site of the injection, fatigue, headaches, muscle pain or a cold, ”said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA).

In addition, the United States authorized since November 3 the vaccination of 5-11 year olds, Israel since November 14, and Canada on November 24. We have little hindsight, but no alarming signal. “What is reassuring is that in countries which have already started to vaccinate 5-11 year olds, there is no return of adverse effects, underlines Frédéric Rieux-Laucat. Particularly of the myocarditis type, which is the dreaded one. Knowing that in the United States, 5 million children are vaccinated. We don’t have a very different child population from the United States or Israel. There is therefore no reason to believe that there would be a higher risk in European children. If there are other side effects, we would have known. “And” the fact that there has been very little in adolescents between 12 and 17 years old, vaccinated since June, is also reassuring “, continues the immunologist.

Why vaccinate all children when they are little at risk from Covid-19?

In its opinion on Tuesday, the High Authority of Health recalls that only three deaths directly linked to Covid-19 have been recorded in children aged 5 to 11 years since March 2020. But “among the complications observed in children,” pediatric multi-system inflammatory syndromes “(PIMS ) are rare but serious and need to be detected early in order to initiate hospital treatment. Since March 2, 2020, 781 cases of PIMS have been reported by pediatricians, 318 required a stay in intensive care and 199 in a critical care unit. “

“It’s not nothing,” breathes the immunologist. If we have the capacity to prevent several hundred children from developing severe forms of Covid-19, why not do it? There is also the debate over the long forms of Covid-19, which could affect children, but not everyone agrees.

And the immunologist to defend the government’s decision to expand this access. It is about “vaccinating 100% of children to protect a small part of the population, very fragile.” This is what is happening today with measles, for example. “

The other data to take into account, according to this researcher, is the fact that “the virus mainly circulates in children. However, we know that vaccination will help prevent class closures, detrimental to the most vulnerable. And we know that this has a psychological impact on these children. “

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