An important step has been taken in the United States towards the vaccination of infants and toddlers against Covid-19. Experts, members of an advisory committee, gave a favorable recommendation, Wednesday, June 15, for the authorization of vaccines from Moderna and Pfizer from the age of 6 months. As in many countries, this is the last age group not yet to have access to this protection. In France, vaccination for 5-11 year olds was opened in December 2021 and younger children are not yet affected.
During discussions broadcast live on the internet, they reviewed all the data from 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. In two votes, the 21 experts unanimously felt that the benefits of vaccinating toddlers with Moderna and Pfizer outweighed the risks. “I know that many very relieved parents are certainly listening to us today”commented Jay Portnoy, one of the committee members.
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. CDC experts will meet 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 shots required: Moderna’s vaccine is 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.
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.