Lethality, side effects, testing and liability: 4 myths about vaccinating children against Covid

In December last year, Anvisa approved the use of the Pfizer vaccine against Covid-19 in children between 5 and 11 years old. Since then, a lot of false information about the vaccination of children has been circulating on social media. THE Forget verified some of the most popular and persistent myths about vaccinating children. Check out:

The number of deaths caused by Covid-19 in children and adolescents is insignificant, and therefore vaccination in this age group is unnecessary.

FAKE

Although Covid-19 tends to be more severe in adults and especially the elderly, more than 2,000 children and adolescents have been victims of the disease in Brazil since the beginning of the pandemic.

According to the Special Epidemiological Bulletins Covid-19 (BE) 44 and 92, from the Ministry of Health, at least 2,625 children and adolescents aged between 0 and 19 years old died from the disease in 2020 and 2021, representing 0.5% of victims.

In the period, 34,538 young people in this age group were hospitalized, representing 2% of hospitalizations for the disease. The data is incomplete, and the actual number must be greater.

BE 92, with the most recent data for 2021, does not count occurrences from the 48th week of the year.

A survey carried out by Unicef, with data from 106 countries, shows that people under the age of 20 accounted for 0.4% of deaths caused by Covid-19. In absolute numbers, there were about 12,300 victims aged up to 19 years. Information was collected from January 2020 to December 2021.

In addition, children and adolescents with mild symptoms of the disease can transmit the disease to other people, such as relatives or teachers. Vaccination, while not completely eliminating transmission of the virus, helps to reduce this possibility.

Statistically, the vaccine is much more dangerous for children and adolescents than the disease.

FAKE

According to data from the CDC (Center for Disease Control and Prevention, United States), until December 19, 8.7 million doses were administered to children aged between 5 and 11 years. There was no confirmation of death caused by the vaccine. Two cases were still under review.

In another report published by the institution, only eight cases of myocarditis in children caused by the vaccine were confirmed, and none of them caused death.

On the other hand, a survey by Unicef ​​shows that 4.7 million children between five and nine years old contracted Covid-19 in 102 countries around the world, and 1,788 of them died. That means a case fatality rate of four in 10,000, or 0.04%.

It is possible that this rate is lower due to underreporting of cases. However, statistically, the data currently available show that a child is much more likely to die from Covid-19 than from the vaccine.

The vaccine has not been tested on children.

FAKE

Pfizer has conducted clinical trials on children in the United States, Finland, Poland and Spain. The results were consolidated in the last month of October and indicated 90.7% effectiveness in preventing the disease in children aged 5 to 11 years.

The World Health Organization (WHO) attested to the quality of the tests carried out by the pharmaceutical company. In addition to Anvisa, the FDA (Food and Drugs Administration, USA) and the EMA (European Medicine Agency, European Union) also approved the application of the immunizer in this age group, both last year.

​The pharmaceutical company is not responsible if serious adverse effects occur.

FAKE

The pharmaceutical must follow a series of safety protocols at the time of registration and after the start of vaccine application.

Resolutions 406 of July 22, 2020 and RDC 475 of March 10, 2021 determine that it is mandatory for package inserts to report adverse effects identified during the testing phase.

In addition, it is necessary for the company to make available the contacts of Anvisa’s notification channel in case of new adverse events.

Pharmaceutical companies, clinics, health professionals must report any case of possible side effect to Anvisa within 24 hours, counted from the date of identification of the clinical condition.

From the notification, Anvisa can request documents that can support the analysis of the problem and even inspect the immunizing factory or the clinic where it was administered, in case of suspicion of poor conservation of the material.

Failure to comply with the protocol is considered a sanitary violation by Law 6437 of 1977. In this case, it is subject to punishment, which can range from a warning to the removal of the product from circulation and/or closure of the facilities. Proof of ineffectiveness of the products for the established purpose may also result in their withdrawal from circulation, according to Law 6,360 of 1976.

The director general of Cepedisa/USP, Fernando Aith, explained that if it is proved that the pharmaceutical company omitted any information to Anvisa (such as a serious adverse effect), it can be punished both by Law 6437 of 1977, for non-compliance with regulatory standards, as by article 927 of Law 10.406/2002 of the Civil Code, for damage to third parties caused by the practice of an illicit act.

“If it is proven that the pharmacist withheld information, she can be sued for having committed a crime. She is civilly and criminally liable. [O paciente] can file a civil action for compensation for moral and material damage, resulting from a product that was consumed without warning of a risk that was not alerted”, he says.

If the adverse effect is identified after the leaflet is issued, the person who feels injured can also sue the pharmaceutical in court — even if the company has notified Anvisa and updated the leaflet of the immunizer after the identified fact. Aith says that this is a right guaranteed by item XXXV of article 5 of the Federal Constitution, which determines that “the law shall not exclude injury or threat to the right from the Judiciary’s appreciation”.