AFP, published Wednesday, June 15, 2022 at 10:20 p.m
A crucial step towards vaccinating infants and young children against Covid-19 was taken in the United States on Wednesday with the positive recommendation from experts for the approval of vaccines from Moderna and Pfizer from the age of 6 months.
During discussions, which were broadcast live on the Internet, members of this advisory committee reviewed all data from the available clinical trials conducted at Pfizer with children aged six months to four years and at Moderna with children aged six months to five years became.
As in many countries, this is the last age group not to have access to this protection.
In two votes, the 21 experts agreed that the benefits of vaccinating young children with Moderna and Pfizer outweigh the risks.
“I know there are definitely a lot of very relieved parents listening to us today,” commented Jay Portnoy, one of the committee members.
Based on these reports, the American Medicines Agency (FDA), whose decisions relate to the world, is now responsible for official approval.
About 10 million doses will then be sent immediately to all corners of the country, before millions more to follow in the following weeks, the US government said.
The injections could start as soon as next Tuesday, as soon as the Centers for Disease Control and Prevention (CDC) give the green light. The CDC experts will meet them this Friday and Saturday.
– Pfizer in three doses –
The doses of these vaccines have been adjusted: Moderna is a quarter (25 micrograms versus 100 in adults) and Pfizer is a tenth (3 micrograms versus 30) that of adults.
The main difference between the two products is the number of vaccinations required: Moderna’s vaccine is still given in two doses a month apart. However, a Moderna representative said studies are already being planned into a booster dose.
Pfizer’s is given immediately in three injections, two doses of which failed to elicit an adequate immune response due to the low dosage. The first two injections of Pfizer will be given three weeks apart, with the third eight weeks after the second.
Several experts stressed that it is important for parents to know that after just two doses of Pfizer, their children will not be adequately protected and will have to wait for the three doses – and therefore several months – before they are.
Both vaccines are safe and effective, according to the FDA, which released its own analysis of clinical trials late last week to provide experts with a basis for discussion.
According to a preliminary estimate, the vaccine from the Pfizer-BioNTech alliance proved to be 80% effective against symptomatic forms of the disease. But that number is based on a very small number of positive cases, the FDA qualified.
Moderna’s vaccine has been shown to be 51% effective in babies aged 6 months to less than 2 years and 37% effective in children aged 2 to 5 years. These numbers are consistent with the efficacy observed in adults against the Omicron variant, according to the American agency. However, the vaccine still protects them well against severe cases of Covid-19.
– impatience or skepticism –
In terms of side effects, about a quarter of the toddlers who received Moderna developed a fever, especially after the second dose. It usually subsided after a day.
At Pfizer, the rate of fevers observed was comparable between children who received the vaccine and those who received a placebo.
While some parents eagerly await the opportunity to vaccinate their offspring, others will no doubt be skeptical. According to a survey in May, only one parent of a child under 5 in 5 (18%) wanted to vaccinate them as soon as possible.
Although the youngest are less susceptible to COVID-19 and at low risk, about 480 children under the age of 4 have died in the United States.
Hospitalization rates also increased sharply for this age group during the wave associated with the Omicron variant. In total, 45,000 children under the age of five have been hospitalized in the United States since the pandemic began, with a quarter requiring intensive care.
Like adults, children infected with Covid-19 can also suffer from long-term symptoms (Covid long). In rare cases, they can also develop severe cases of pediatric multisystem inflammatory syndrome.