Desinfox | Covid-19: Have 86% of vaccinated adolescents “suffered serious side effects”? – Progress

It is a widely shared and commented publication since this summer: it claims that “86% of children between the ages of 12 and 15” who received the Pfizer / BioNTech vaccine “suffered side effects” in clinical trials conducted before the authorization of these vaccines for adolescents, last spring.

It is “a crime!”, “A shame”, exclaim internet users.

This figure, presented as such, is false: it actually designates, according to the results of the clinical study published on May 27 in The New England Journal of Medicine, the proportion of vaccinated adolescents … who had a sore arm after the injection.

To be precise, adolescents 12 to 15 years old, at the time of the first dose. For 16-18 year olds, the proportion fell to 83% during the first dose.

And for the second dose, 79% of 12-15 year olds and 78% of 16-18 year olds felt this pain, sometimes accompanied by fever.

Mostly a “pain at the injection site”

According to the full results of this study, a few serious side effects have been reported after vaccination in young people, but they are rare.

Certain more serious side effects, in particular inflammation of the pericardium and myocardium, have been reported since the start of the vaccination campaigns, but they are rare, benign and ephemeral, according to pharmacovigilance carried out by pharmacovigilance agencies.

Moreover, the figure of 86% mentioned in the publication appears only once in the report.

The authors write that the vaccine exhibits a “favorable side effect profile, with mainly mild to moderate transient reactogenicity (mainly pain at the injection site). [chez 79 à 86 % des participants], fatigue [chez 60 à 66 %] and headaches [chez 55 à 65 %]). “

“No serious adverse events”

And add “that no SAE / SAR (for” Serious adverse event “, serious adverse event, editor’s note) linked to the vaccine has been observed and few serious adverse events overall”.

In detail, we learn from the graph presented above that “86% of vaccinated adolescents felt pain at the injection site after the first dose of vaccine, against 23% of adolescents who received a dose of placebo. At the second injection of the vaccine, 79% of adolescents experienced pain at the injection site, compared to 18% in the placebo group.

On May 28, 2021, the European Medicines Agency (EMA) approved the use of the Pfizer / BioNTech vaccine for adolescents over 12 years of age. She judged the side effects seen in clinical trials to be “similar to those seen in people 16 years of age and older. They include injection site pain, fatigue, headache, muscle and joint pain. , chills and fever. These effects are usually mild or moderate and improve within a few days of vaccination. “

In mid-July, the AEM also authorized the use of Moderna’s vaccine for adolescents.

Rare serious side effects

Since the start of vaccination for children over 12 years old in the United States, France and Belgium, several cases of myocarditis (a cardiac inflammation) in vaccinated adolescents have been notified to pharmacovigilance agencies. These myocarditis mainly affected young men after receiving the second dose.

In June, US experts met to study 323 cases of heart inflammation triggered in adolescents after injection of Pfizer / BioNtech and Moderna. They concluded that there was a “likely” link between these vaccines and the rare cases of myocarditis, but that in most cases they were “mild cases, with individuals often recovering on their own or with severe disease. minimal processing “.

In a statement released in early August, the US CDC reported the experts’ decision: “On June 23, 2021, the CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed the available data and concluded that the benefits of immunization against Covid-19 for individuals and the population outweigh the risks of myocarditis and recommended continuing use of the vaccine in people over the age of 12 ”.

Sweden suspends Moderna for the youngest

However, these side effects continue to be monitored by pharmacovigilance agencies. In its follow-up report for adverse reactions published on August 26, 2021, the French National Medicines Safety Agency (ANSM) mentioned 33 cases of myocarditis and 15 cases of pericarditis (inflammation of the pericardium, in the heart) reported to the date August 26. 3 of them concerned adolescents aged 12 to 15 years.

Following the reports, Sweden suspended Moderna’s Covid vaccine “as a precaution” for those under 30, while acknowledging that the risk of myocarditis was “minimal”. In Denmark and Norway, Moderna’s vaccine has been suspended for those under 18.

Adolescents can also suffer from severe forms of Covid-19

Adolescents and children are not among the populations most at risk of developing a severe form of Covid-19, unlike the elderly or adults with co-morbidities.

On its website, the World Health Organization (WHO) estimates that, as children and adolescents tend to develop a milder form of the coronavirus, “unless they are part of a high-risk group for severe COVID-19, it is less urgent to vaccinate them than those more elderly, chronically ill and health care workers.

WHO does not currently recommend vaccination for adolescents, although it recognizes the effectiveness of Pfizer’s vaccine for “people aged 12 and over.”

Nevertheless, we cannot say that the youngest “fear nothing of the Covid”: “Some children are hospitalized after having caught the Covid”, testifies Annie Robert, head of the research center in epidemiology and biostatistics at UCL. “The frequencies are not high, but it is not uncommon.”

There is also the famous “Covid long”: the United Nations website indicates that “children and adolescents can present with prolonged clinical symptoms (known as the post Covid-19 state or post-acute sequelae of the infection with SARS-CoV-2) “, but that” their frequency and characteristics are still being investigated “.

Scientists also recall that the youngest can also catch and transmit Covid-19 to more fragile people, an argument used by countries that have chosen to vaccinate adolescents.