Antivacine site invents data on side effects in children immunized with Pfizer – 08/23/2021 – Balance and Health

The publication on the anti-vaccination website Colectivity Evolutionary according to which data from the pharmaceutical company Pfizer would have shown that “80% of vaccinated children develop adverse effects” is false.

One of the fake content links, verified by Projeto Comprova, leads to a page in German, from where the text in Portuguese was translated. In the foreign version there is a link to a document from the FDA (Food and Drug Administration), a regulatory agency in the United States, cited as the source of such data, but it is only a technical sheet for health professionals who apply vaccines. In this report, there is information about adverse reactions in audiences of different ages, but at no time does it mention the 80% of cases of vaccinated children who would have developed adverse effects.

Pfizer told the report that in June it announced the start of testing the vaccine in a group of children under 12, but no results were available yet.

The company added that “the benefits of vaccination far outweigh the potential adverse events.” It is the same as affirmed by the CDC (Center for Disease Control) of the United States and Anvisa (National Health Surveillance Agency).

Comprova considered the content false because it was deliberately invented and publicized to spread a lie. The report tried to talk to the website that published the material, but did not get a response until the publication of this text.

How do we check?

The first step was to check where the links included in the verified post led. The first of them, right at the beginning of the text, suggested that the reader would be taken directly to a supposed 37-page Pfizer report, which contained information about adverse reactions in 80% of the vaccinated children.

The link, however, led to an Austrian website, with text written in German. Using Google’s translation tool, the report found that the content was similar, albeit larger. This, yes, provided a direct link to the supposed report, which, in fact, was a technical sheet for professionals responsible for administering the vaccines, made available by the FDA, but without the data highlighted by either text.

Research on the immunization of children and adolescents was carried out on the Pfizer website and on the pages of health authorities such as CDC, FDA and Anvisa.

The report contacted Pfizer by email, which responded with a statement. He also tried to talk to Coletividade Evolutiva via email and filling out the contact form on the website, but he didn’t get any feedback until the publication of this text.

Verification

do in children

According to a statement from the pharmacist sent to the report, there is still no data available on the results of the vaccination of children under 12 years old. In June, the company announced the start of tests in this group, but did not say when the results should be published.

“Phase 2/3 of the trial will have up to 4,500 participants aged 11 or younger in the United States, Poland and Spain at more than 90 clinical trial sites,” the document says.

About the report

Cited as the source of the verified text data here, the FDA report is true, but it does not contain the information alleged by the original text and by the translation published in Brazil. In the 39-page document, there is information about adverse reactions in audiences of different ages, but also how to pack, dilute and apply a dose of the vaccine.

The post verified here states that 80% of children who received the Pfizer vaccine had adverse effects and that at least 80% can expect “traumatic” adverse reactions. The document does not show this percentage, nor the 79% mentioned in the original text of the Austrian website. There is also no mention of “traumatic” reactions or a report published by Pfizer on May 19th.

According to the document, which had the last update on the website on August 12, 2021, the adverse reaction that reached the highest percentage of people vaccinated by Pfizer aged between 12 and 15 years was pain at the injection site (86.2% after the first dose).

In this same age group, adverse events considered serious were manifested in 0.4% of those who received the vaccine, after the second dose. In the age-matched placebo group, these reactions occurred in 0.1% of participants. Of the 2,260 adolescents aged 12 to 15 years who participated in Pfizer Study 2 in the United States, 1,131 received the vaccine and 1,129 received the placebo.

In a clinical study, adverse reactions in adolescents aged 12 to 15 years included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills ( 49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%) and nausea (0.4%).

Cases of severe allergic reactions, myocarditis and pericarditis have been reported after vaccine administration outside of clinical trials.

Pfizer Study

In a clinical study with young people aged 12 to 15 years, the vaccine “demonstrated 100% efficacy”, according to the company informed the report. “The phase 3 trials were conducted in 2,260 adolescents in the United States and showed robust antibody production responses and an acceptable safety profile similar to other age groups was also established.”

Also according to the document, the most common adverse reactions, in 10% of patients, and common (between 1% and 10%) “may include pain, swelling or redness at the injection site, tiredness, headache, diarrhea, muscle pain, joint pain, chills and fever, as well as nausea and vomiting”.

Pdo in young people

Unlike other immunizers, the youngest group to receive Pfizer in the clinical trials phase was between 16 and 25 years old – which made it possible for the initial approval of the immunizer to consider older adolescents as eligible to receive the doses. Then, thanks to studies released at the end of March, regulatory bodies expanded the possibility of applying the vaccine.

Pfizer has been used by ages 12+ since May. The first agency to authorize this use was the CDC, on May 12, 2021. Days later, the European Union also authorized the use of the immunizing agent in this age group.

Israel also authorized the vaccination of teenagers in May with Pfizer doses and, in the UK, it was in early June.

In Brazil

Around here, Anvisa authorized the use in adolescents, from 12 years old, on June 11th. As the agency itself points out, this is the only immunizing agent approved for use in minors in the country.

By decision of the Ministry of Health, the vaccination of adolescents, between 12 and 17 years old, must take place in the states after the end of the application of the first dose, by age group, in adults.

As the pace of vaccination is not the same in all states, the article sought information about the 26 states and the Federal District and found that at least the following locations have already started immunizing adolescents (until August 20): Acre; Amapá; Amazons; Federal District (in the case of adolescents with disabilities or syndromes, and before the end of vaccination for adults); Maranhão; Mato Grosso do Sul; Pernambuco; Rio Grande do Sul; Rondônia; Roraima and São Paulo.

In Minas Gerais, the city of Betim, in the metropolitan region of Belo Horizonte, and, in Pará, Ananindeua, in the metropolitan region of Belém, have also started to vaccinate minors.

The website

This is not the first post on the Evolutionary Collective website that contains false information about vaccination. There is, on the page, a “manipulation” section, with texts about the supposed experimental character of vaccines against covid and about the magnetic effect of the immunizing agent.

The Austrian website Report24, which had the post translated, has also published other conspiratorial and anti-vaccination content.

Why do we investigate?

In its fourth phase, Comprova checks suspicious content about the pandemic, public policies of the federal government and elections that go viral on the networks. The text verified here entered the Comprova watch list via WhatsApp reader requests (if you have any questions about some content, you can send it to the phone 11 97045-4984 or by clicking on this link).

Content that tries to discredit vaccines is dangerous because it can put the population at risk.

Comprova has already clarified several contents about immunization, such as, for example, that it is false that the hospitalization of Silvio Santos by Covid indicates ineffectiveness of Coronavac, which is a misleading post that states that the CDC and Anthony Fauci do not believe in the vaccine, that the positive diagnosis de Doria does not indicate ineffectiveness of Coronavac and that it is false that immunizers used in Brazil have not passed safety and efficacy tests.

False, for Comprova, is content invented or edited to change its original meaning and deliberately disclosed to spread a lie.

Comprova made this verification based on information available on August 20, 2021.