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US experts on Wednesday recommended vaccines from Moderna and Pfizer from the age of six months. The American health authorities must now give their official authorization, and the injections, with an adapted dosage, could start next Tuesday.
A crucial step was taken on Wednesday June 15 in the United States towards the vaccination of infants and toddlers against Covid-19, with the favorable recommendation of experts for the authorization of vaccines from Moderna and Pfizer from six months of age. ‘age.
During discussions broadcast live on the internet, the members of this advisory committee reviewed all the data from the available clinical trials, conducted in children from six months to 4 years old at Pfizer, and from six months to 5 years old at Moderna. As in many countries, this is the last age group not yet to have access to this protection.
In two votes, the 21 experts unanimously felt that the benefits of vaccinating toddlers with Moderna and Pfizer outweighed the risks.
On the basis of these opinions, the American Medicines Agency (FDA), whose decisions refer to the world, is now responsible for giving its official authorization. Some 10 million doses will then be immediately sent to the four corners of the country, before millions more in the following weeks, the US government said.
Injections could begin as early as next Tuesday, once the Centers for Disease Control and Prevention (CDC) also gives the go-ahead. The CDC experts will meet them this Friday and Saturday.
The dosage of these vaccines has been adapted: it is a quarter of that of adults for Moderna (25 micrograms, against 100 for adults), and a tenth for Pfizer (3 micrograms, against 30).
The main difference between the two products is the number of injections required: Moderna’s vaccine will always be administered in two doses a month apart. A Moderna representative, however, said studies were already planned on a booster dose.
That of Pfizer will be done immediately in three injections, two doses having not provoked a sufficient immune response due to the low dosage. Pfizer’s first two injections will be given three weeks apart, and the third administered eight weeks after the second.
Several experts stressed that it was important for parents to know that their children would not be adequately protected after just two doses of Pfizer, and would have to wait for the three doses – and therefore several months – before they were.
Both vaccines are safe and effective, according to the FDA, which released its own analysis of clinical trials late last week to provide a basis for discussion for experts.
According to a preliminary estimate, the vaccine from the Pfizer-BioNTech alliance was found to be 80% effective against symptomatic forms of the disease. But this figure is based on a very small number of positive cases, qualified the FDA.
Moderna’s vaccine has been shown to be 51% effective in babies 6 months to less than 2 years old, and 37% in children 2 to 5 years old. These figures are consistent with the efficacy observed in adults against the Omicron variant, according to the American agency. However, the vaccine continues to protect them well against serious cases of Covid-19.
Regarding side effects, about a quarter of young children who received Moderna developed a fever, especially after the second dose. It usually subsided after a day. At Pfizer, the fever rate observed was comparable between children who received the vaccine and those who received a placebo.
Impatience or skepticism
While some parents eagerly await the possibility of vaccinating their young offspring, others will undoubtedly be skeptical. According to a survey in May, only one parent of a child under 5 in five (18%) wanted to vaccinate them as soon as possible.
Although the youngest are less vulnerable to Covid-19 and the risk for them is low, some 480 children under the age of 4 have nevertheless died in the United States.
Hospitalization rates also increased sharply for this age group during the wave linked to the Omicron variant. In total, there have been 45,000 children under the age of five hospitalized in the United States since the start of the pandemic, a quarter of whom have required admission to intensive care.
Like adults, children infected with Covid-19 may suffer from long-term symptoms (Covid long). In rare cases, they may also develop severe cases of pediatric multisystem inflammatory syndrome.