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

After the green light from the High Health Authority last week, Jean Castex announced this Monday night that children from 5 to 11 years old 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 from 5 to 11 years old at risk, that is, those who suffer from obesity, respiratory and heart diseases,” said Olivier Véran.

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

What vaccine will children be injected with?

At the moment, only the vaccine developed by Pfizer / BioNTech is licensed in Europe.

Moderna’s serum for children is being evaluated by the European Medicines Agency. Your opinion is expected at the end of December. In May, since the Haute Autorité de Santé has advised against the use of Moderna for children under 30 years of age in France, it is most likely that Pfizer will remain the only one injected into children.

When will this vaccine 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 start.” Olivier Véran assured this Monday night that the vaccination of vulnerable children could begin 48 hours later, that is, on December 15. What about other children ages 5 to 11? Vaccination could begin on December 20 in vaccination centers and December 27 in cities.

“I make a reservation: we have a favorable opinion from the Steering Committee of Alain Fischer’s vaccination strategy, we are waiting for the green light from the HAS and the National Advisory Committee on Ethics (CCNE),” said Olivier Véran. When contacted, CCNE told us that “at the moment there is no set date yet, the working group is beginning its reflections.”

Is the Pfizer vaccine for children the same as for adults?

Yes, it is the same product. On the other hand, it is less dosed. In fact, it contains “10 micrograms of Pfizer instead of 30 [pour les adultes] “Underlined Alain Fischer, president of the Steering Committee of the anti-Covid-19 vaccination strategy, at LCI.

How effective is this vaccine?

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

After a first phase to determine the correct dose to inject, the phase 2 and 3 trial involved 2,268 children: 1,517 received a Pfizer vaccine and 751 a placebo. “A symptomatic infection more than seven days after the second dose occurred in three vaccine recipients and in sixteen children who had received placebo,” adds Frédéric Rieux-Laucat, director of research on pediatric autoimmune diseases and team leader at Imagine Institute. The study, carried out on a limited sample, therefore concludes with an efficacy 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. “Side effects, which can last for a few days, were classified as ‘mild or moderate’ and can manifest as localized pain at the injection site, fatigue, headache, etc., muscle pain or a cold,” said Marco Cavaleri. Head of Vaccine Strategy at the European Medicines Agency (EMA).

In addition, the United States authorized the vaccination of 5-11 years from November 3, Israel from November 14 and Canada on November 24. We have little hindsight, but no alarming signs. “What is reassuring is that in countries that have already started vaccinating children between the ages of 5 and 11, the adverse effects do not return, stresses Frédéric Rieux-Laucat. Particularly of the type of myocarditis, which is the dreaded one. Knowing that in the United States, 5 million children are vaccinated. We do not have a child population that is very different from that of the United States or Israel. Therefore, there is no reason to believe that there is an increased risk in European children. If there are other side effects, we would have known about it. And “the fact that there is very little in adolescents between 12 and 17 years, vaccinated since June, is also reassuring,” continues the immunologist.

Why vaccinate all children when they are at low risk for Covid-19?

In its opinion on Tuesday, the High Authority for Health recalls that there have only been three deaths directly linked to Covid-19 in children aged 5 to 11 years since March 2020. But “among the complications observed in children, syndromes Pediatric Multisystemic Inflammatory Symptoms ”(PIMS) are rare but serious and must be detected early to initiate hospital treatment. As of March 2, 2020, pediatricians have reported 781 cases of PIMS, 318 requiring a stay in intensive care and 199 in a critical care unit. “

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

And to 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, which is 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 circulates mainly in children. However, we know that vaccination will help prevent the closure of classes, which is detrimental to the most vulnerable. And we know that this has a psychological impact on these children. “

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