The list of adverse effects of the covid vaccine in children is updated: these are the new symptoms detected

The system of vaccine pharmacovigilance from the Centers for Disease Control and Prevention EE UU (CDC, for its acronym in English) collects in its latest report, dated January 5, that of the 8,674,378 doses administered against covid-19 between November 4 and December 16, 2021 to American boys and girls from 5 to 11 years they have reported 4,149 mild adverse effects (98% of the total) and 100 (2%) cases of serious side effects. Three children died, two of whom had a “complicated medical situation” and the third died of the flu.

This is how the last one picks it up report published by the VAERS of the US CDC, which is the equivalent of the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Centers of Pharmacovigilance and coordinated by the Spanish Agency for Medicines and Health Products ( Aemps). In Spain, latest data published on events reported as adverse effects of vaccines dates from December 20 and includes data up to December 12, three days before the pediatric vaccination campaign began in Spain with the pfizer vaccine.

While the data for the Spanish child population arrive, the information that is already available in the US shows that 98% of the notifications correspond to mild adverse effects. Of the 4,149 reported cases, the most frequent are classified as an unidentified “non-adverse event” (1,183), or correspond to a “problem in the preparation of the product” (925), or to an “incorrectly administered dose” (704). The report also includes 326 notifications of doses lower than indicated.

The fifth most common non-serious adverse effect has been vomiting, with 326 cases, followed by fever (296), headache (260) and syncope (256).

Regarding the 100 cases of serious effects collected (2% of the total notifications), 29 were cases of fever; 21 from vomiting; 15 of increased troponin, which is a type of protein found in the muscles of the heart; 12 chest pain; and 11 for elevated C-reactive protein, which is a marker in plasma indicating suspected infection or inflammation. The table of serious adverse effects also includes 12 cases of “normal echocardiogram” and 11 blood tests and as many negative tests for SARS-CoV-2 (the coronavirus that causes covid-19). According to the pediatrician Quique Bassat, these are “tests that have been requested of children with certain symptoms.” The researchers add that the mistaken administration of an adult dose has not caused any serious effects.

Side Effects of Pfizer's Covid Vaccine in Boys and Girls 5 to 11 Years Old.
Side Effects of Pfizer’s Covid Vaccine in Boys and Girls 5 to 11 Years Old.
Pedro’s henna

Myocarditis

The report also notes that 16 suspected cases of myocarditis have been reported in children from 5 to 11 years old, of which 12 fit the definition Of this adverse effect, three were still undergoing medical study at the time of writing the report and one was ruled out. Post-vaccination myocarditis occurred in children between 9 and 11 years old and two or three days after the injection. Most (9) occurred after the second dose and in boys (67%, compared to 33% in girls). All have been discharged from home.


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With these data, US experts calculate a myocarditis rate after receiving the Pfizer vaccine of 4.3 cases per million doses administered for children ages 5 to 11. In girls of this age the rate drops to 2 cases per million doses.

The incidence of myocarditis among children aged 5 to 11 years is 10 times lower than that of adolescents from 12 to 15 years (45.7 cases per million vaccines administered) and 16 times less than that registered among young people between 16 and 17 years of age, according to this same VAERS report, which also collects pharmacovigilance data for the vaccine of 12 to 15 years and the booster dose in adolescents 16 to 24 years.

For the pediatrician and epidemiologist Quique Bassat, member of the committee of the Spanish Association of Pediatrics that has advised the Government in the elaboration of the sanitary protocols in the educational centers, affirms that these figures are “very reassuring”, while highlighting that “they confirm that myocarditis is most likely related to the total dose of injected vaccine -which in those under 12 years is a third of the dose inoculated in those over 12 and the rest of the adult population – They are very good data that continue reinforcing the message that vaccines in children under 12 years of age they are very safe“.

These are “very reassuring” figures that confirm that myocarditis is related to the total dose of the vaccine.

The report, signed by Dr. John Su, a member of the CDC Advisory Committee on Immunization Practices (ACIP), concludes that of the nearly 8.7 million doses of Pfizer administered to boys and girls ages 5 to 11, and of the 18.7 million doses inoculated to adolescents ages 12-15 in the US through mid-December, 92% of reported adverse effects were mild, “known and well characterized” in clinical trials, and they were similarly distributed regardless of the sex and ethnicity of the minors. Regarding the risk of suffering myocarditis, this was “considerably lower” among children aged 5 to 11 years than among adolescents 12 to 15.

Coverage in Spain and objectives

In Spain, according to the report published this Monday by the Ministry of Education, the 34,9% of boys and girls aged 5 to 11 have already received the first dose of the vaccine. The second is scheduled eight weeks after the first puncture. The objective that the Government has set itself, as President Pedro Sánchez recalled this Monday, is to reach 70% of the pediatric population with at least one dose on February 7 and for the week of April 8 it is expected that they will already have the full two-dose regimen.

Three nurses administer the coronavirus vaccine to a child in Menorca.
Three nurses administer the coronavirus vaccine to a child in Menorca.
EFE

According to data from the Carlos III Health Institute (ISCIII), the covid has affected children less than adults, but that has not left them exempt from risk. Since the start of the pandemic, 3,486 minors up to nine years of age have been hospitalized for covid in Spain, 199 have required intensive care in an ICU and 25 have died, according to the latest report available from the ISCIII. Data that amount to 49 if adolescents up to 19 years of age are included.

Among the little ones who have entered FIA due to covid in Spain, it is worth recalling the conclusions drawn from a study carried out with 202 patients from 47 hospitals in the first year of the pandemic, which drew the profile of the children who required intensive care. Three-quarters of them, without previous pathologies, developed the serious Multisystemic Inflammatory Syndrome (MIS-C) associated with the coronavirus, a sequel that causes inflammation of some organs and tissues.

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