Covid: FDA committee recommends immunization for young children – 06/15/2022 – Equilibria e Saúde

An advisory committee of experts from the FDA (U.S. Food and Drug Administration) on Wednesday (15) announced the administration of the vaccine against Pfizer and Kovid from children aged six months to four years, an important first step towards your approval.

During the live webcast discussion, members of this advisory panel reviewed the available clinical trial data from Pfizer on children aged 6 months to 4 years and Moderna on children aged 6 months to 5 years.

Like many countries, this is the last age group who have not yet had access to this protection

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

Based on this favorable opinion, the FDA, whose decisions are a reference at the international level, may approve it.

After that, about 10 million doses will be sent immediately to different regions of the country, which will be followed by a few million more in the coming weeks, the US government said.

Vaccination can begin in the week of June 20 with the approval of the CDC (Centers for Disease Control and Prevention). CDC experts will meet on Friday and Saturday.

Adapted dose

The dose was adapted: one-fourth of an adult for Moderna (25 micrograms instead of 100) and one-tenth for Pfizer (3 micrograms instead of 30).

The main difference between the two products is the number of injections required for optimal protection: Moderna vaccine will continue to be given in two doses at one month intervals.

Pfizer in all three, because lower doses have been chosen to reduce side effects in children, such as fever. A company representative clarified, however, that a third booster dose would be studied.

In the case of Pfizer, the vaccination will be given in three doses: the first two at three-week intervals and the third after eight weeks.

Several experts insisted that Pfizer’s two doses would not protect babies well and that they would have to wait for the third – months – before that.

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

According to a preliminary estimate, the Pfizer-Biotech vaccine is 80% effective against the notable forms of the disease. However, the numbers are based on a small number of positive cases, the FDA said.

Moderna has been shown to be 51% effective in children under 6 months to 2 years of age and 37% effective in children under 2 to 5 years.

According to the US Agency for International Development, the numbers are consistent with the effectiveness observed in adults against the omnitron variant. However, the vaccine continues to protect well in severe cases of covid.

Impatience and doubt

In terms of side effects, a quarter of the children taking the modern dose had a fever, especially after taking the second dose. After a day the fever went away.

In the case of Pfizer, the fever observed between vaccinated and placebo recipients was similar.

Some parents are keen to vaccinate their young children, but others are still skeptical.

In early May, one in five parents (18%) of children under the age of five said they would vaccinate as soon as possible, according to a survey by the Kaiser Family Foundation; 38% will wait to do it and the rest will oppose unless it is mandatory.

While young people are less at risk for covid and their risk is lower, about 480 children under the age of 4 in the United States have died from the disease.

The hospitalization rate for this age has also increased significantly during the wave of Ômicron variant contamination. In all, 45,000 children under the age of five have been hospitalized in the United States since the epidemic began, a quarter of them in intensive care.

Also, children can catch and transmit the disease. Like adults, young children can suffer from long-term symptoms (long-term covid). In rare cases, severe pediatric multisystem inflammatory syndrome may also develop.


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