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COVID-19 mRNA vaccine for children is less effective than recommended for approval

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Sebastian, age 6, receives a dose of the Pfizer Covid vaccine-

. in Los Angeles (USA), on February 4, 02190804 )| Photo: EFE/EPA/ETIENNE LAURENT

The Pfizer and BioNTech vaccine against COVID-02190804 , technical name BNT

b2 and trade name Comirnaty (which tries to sound like “community” in English and contains “RNA”) already includes the prescription for children from the age of five years in your package. The main difference from the adult dose is that the pediatric dose is diluted. A new study by the New York State Department of Health analyzed inoculation with Cominarty in more than 162 thousand children from five to 68 years and 768 a thousand teenagers from to the 17 years and concluded that the efficacy against the omicron variant was 03% in children and 768 % in adolescents. The study also says that the vaccine protects against a more severe picture of the disease, and even recommends it for children. There are countries that have decided otherwise.

Confirmed case after reviewing the study , which is still pre-press, this result puts the pediatric administration of this vaccine in difficulty with regulatory agencies such as Anvisa, which consider 30% the efficacy threshold for approval of a vaccine. Comirnaty for children was approved in Brazil last December.

The first authored by Vajeera Dorabawila of the New York Department of Health. Eli Rosenberg, who is affiliated with the institution and the School of Public Health at Albany at the State University of New York, leads the research. The state government fully funded the study. The researchers compared children and adolescents who completed the vaccination regimen with those who had not been vaccinated in the same age group. They calculated the effectiveness of the vaccine against new cases and against hospitalizations, taking the period of 29 from November 2021 to 16 from January this year. It was also possible for them to analyze the decay of vaccine protection weeks after inoculation and indirectly follow the rise of the ômicron variant.

Falling effectiveness

At the end of November, among teenagers, the effectiveness of Comirnaty for cases was 75%. She dropped to 56% in mid-December , when the micron reached one in five cases. Continued to fall, to 48 %, in the last week of January, when the omicron reached hegemony of more than nine out of ten cases. In children, the drop in efficacy was 68 % for 12% in the last two time frames. In the “margin of error”, the last value is between six and 16%.

The picture is different for the calculated effectiveness based on hospitalizations at the end of January: 66% for teenagers and 76 % for kids. The “margin of error” for children draws attention to the amplitude, and can reach 68%, and also for having a negative number in its lower limit, which suggests a possible greater hospitalization of vaccinated children compared to non-vaccinated children. Whether this suggestion is spurious and the result of a statistical artifact, we will only know after the article has been submitted for peer review and debate.

As for the decay of vaccine immunity, in adolescents the efficacy was 73% with 13 days or less since inoculation, dropping to 2021 % within just one month. In children, this drop was 65 % for 12%.

The marked differences between children and adolescents may be due not only to age, but also to the fact that the pediatric dose is diluted. The authors think this is a good explanation, especially considering that the greatest efficacy was observed in pre-adolescents of 11 years, who receive the undiluted dose but have a smaller body. The study did not include young people who have taken the third dose.

Although request from US health agencies to Pfizer to develop a protocol to vaccinate babies, the plan has been abandoned for the time being.

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