After a day of discussions that was open to the public, the Expert Advisory Committee to the FDA (US Food and Drug Administration) recommended approving the corona vaccine for children ages 5-11. The recommendation was by a majority of 17 in favor and one abstention.

Experts have repeatedly reiterated the statement that the decision is “difficult”. Some expressed their concerns about the small size of the experiment and the lack of long-term information. Another concern of committee members was that approval of the vaccine would lead to the schools’ decision to require a vaccine as a condition of entry. Some experts seem to be more comfortable voting if they knew children would not be required to take the vaccine, but that was not part of the committee’s mandate, and in the end the committee voted ‘yes’ to the question asked, whose wording was: Does the vaccine’s benefit outweigh the risks? His.

The current committee vote does not yet require the FDA to approve the product, however the report the director submitted to the committee as a background for the vote included a statement that the vaccine is effective and that an analysis conducted by the administration found its benefit outweighs its risk at current morbidity levels. Therefore the almost certain assessment is that the FDA will approve the vaccine for children, following the committee’s recommendation. Following this, the vaccine will be approved for all ages except 0-4.

After the committee vote and the expected FDA approval in the next two days, there is another stage where the CDC, the US Centers for Disease Control, is expected to recommend the vaccine to children (FDA approval is not equivalent to the recommendation). In anticipation of the start of the vaccination campaign already in the first days of November.

In Israel, the Ministry of Health is preparing to enter the child vaccination campaign within about two weeks. Thus, it seems that this time Israel will not be the first in line to get vaccinated, but will have a range of a few weeks or at least days, to watch what is happening in the US before the start of the campaign in the country.

Children will be vaccinated with one-third of the vaccine dose given to adults. The vaccines that are in Israel should be sufficient, but make sure that 15-18 children arrive at the vaccination stations at once, in order to avoid wasting packets from opened vials, so the campaign may be logistically complex. As with adults, the best protection of the vaccine on children will be received about a week after the administration of two doses of the vaccine, meaning that the first children will enter under the protection umbrella, about a month after the start of the campaign, around mid-December. Meanwhile, coronary heart disease is on the decline in Israel. Yesterday, only about 900 new infections were confirmed, and about 236 Israelis are defined as severely blue, compared to over 700 at the height of the current wave, only about a month ago.

90% efficiency in a Pfizer experiment

Pfizer’s vaccine was found in a trial of about 3,000 vaccinated children, 90% more effective than an unvaccinated control group. The main target of the experiment was neutralizing antibody levels against corona (Delta strain) in children, and these levels were found to be similar to antibody levels in young people aged 16-25, despite the lower dose.

In the experiment, none of the children developed myocarditis. However, in a benefit-risk analysis conducted by the FDA, a conservative estimate was given that the vaccine would cause inflammation in children at the same rates found in adolescents. Even under this assumption, the vaccine significantly prevents more hospitalizations at current morbidity levels than it may cause. At very low morbidity levels, the number of hospitalizations among boys is similar, but even in such a case, say the FDA, when considering also the relative severity of the disease when a child is hospitalized with corona compared to when he is hospitalized with myocarditis, and when children are also taken into account With severe coronary heart disease who have not been hospitalized have sometimes suffered a tumultuous illness with long-term consequences, probably even in this scenario of very low morbidity, the benefits of the vaccine outweigh its risks. To date, 94 children aged 5-11 from Corona have died in the United States.

In today’s discussion it was said that myocarditis due to a viral disease appears in the highest rates in male adolescents, and it is estimated that the morbidity is mediated by high testosterone levels. If this is also true for vaccine-induced myocarditis, then we would expect to find lower rates of the phenomenon in children before adolescence. It has also been said that although myocarditis after vaccination has so far been found to be mild and usually transient, a long-term effect on the heart cannot be ruled out.

Dr. Ofer Levy, a former Israeli who currently works at the Children’s Hospital in Boston, noted that these antibodies are not a perfect measure of the level of protection. He added an interesting issue would be the vaccination of recovering children. Special in recovering children that includes only one dose or not at all. Levy told Globes last week that he vaccinated all his children who had already reached the age of vaccination, and estimated that the vaccine could be approved for children.

There is currently no talk of a booster order for children in half a year, although this discussion may take place later.

By Editor

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