US committee recommends Covid vaccines for children over 6 months

An advisory committee of experts from the FDA (the drug and food regulatory agency of the United States) pronounced this Wednesday (15) in favor of the administration of vaccines against Covid from the Pfizer and Moderna laboratories in children from six months to four years, a crucial first step towards your authorization.

During live webcast discussions, members of this consultation panel reviewed available clinical trial data performed by Pfizer on children aged six months to 4 years and by Moderna on children aged six months to 5 years.

As in many countries, this is the last age group that still does not have access to this protection.

In two votes, the 21 experts unanimously considered that the benefits of vaccinating this age group outweigh the risks.

Based on these favorable opinions, the FDA, whose decisions are a reference at the international level, could grant its authorization.

Then, about 10 million doses would be shipped immediately to different regions of the country, which would be followed by millions more in the coming weeks, the US government said.

Vaccination can start the week of June 20, once the CDC (Centers for Disease Control and Prevention) gives the go-ahead. CDC experts will meet on Friday and Saturday.

adapted doses

The dose was adapted: a quarter of that of adults for Moderna (25 micrograms instead of 100) and a tenth for Pfizer (3 micrograms, against 30).

The main difference between the two products is the number of injections needed for optimal protection: Moderna’s vaccine will continue to be given in two doses, one month apart.

Pfizer in three, because of the low dose chosen to reduce side effects in babies, such as fever. A company representative clarified, however, that studies will be carried out on a third booster dose.

In the case of Pfizer, the immunization will be carried out in three applications: the first two three weeks apart and the third eight weeks after the second.

Several experts stressed that children would not be well protected on two doses of Pfizer and would have to wait for the third — that is, months — before then.

The vaccines are both safe and effective, according to the FDA, which published its own analysis of clinical trials last week to provide a basis for expert discussions.

According to a preliminary estimate, the Pfizer-BioNTech vaccine is 80% effective against symptomatic forms of the disease. But that number is based on a small number of positive cases, the FDA said.

Moderna’s has been shown to be 51% effective on babies aged six months to less than 2 years and 37% effective on children aged two to five years.

The numbers are consistent with the efficacy observed in adults against the omnitron variant, according to the US agency. However, the vaccine continues to protect well against severe cases of Covid.

impatience and skepticism

Regarding side effects, a quarter of the children who received the dose of Moderna had fever, especially after the second dose. The fever passed after a day.

In the case of Pfizer, the observed fever was similar between vaccinees and those who received placebo.

Some parents are excited about the possibility of vaccinating their young children, but others are still skeptical.

According to a survey by the Kaiser Family Foundation, as of early May, only one in five parents of a child under five (18%) said they would vaccinate as soon as possible; 38% will wait to do so and the rest are opposed unless it is mandatory.

Although younger people are less vulnerable to Covid and the risk to them is low, about 480 children under the age of 4 have died in the United States from the disease.

Hospitalization rates also increased markedly for this age group during the wave of contamination of the Ômicron 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, of whom a quarter have been in intensive care.

Children, in addition, can catch and transmit the disease. Like adults, little ones can suffer from long-term symptoms (long-term Covid). In rare cases, severe pediatric multisystem inflammatory syndrome can also develop.