There were no serious cases, hospitalizations or deaths with such a small number of participants.
Thus, as for adolescents and adults, the vaccine has shown very high efficacy. A good result, considering that the dose of the active ingredient in the vaccine – 10 μg – is three times less than in the “adult” version (and 10 times less than that of Moderna).
What about security?
By the time the documents were submitted to the FDA, 3,082 children had received the vaccine. In general, the vaccine was more tolerated in children than in adolescents and adults. Compared with placebo, the incidence of pain at the injection site, fatigue and headache, and lymphadenopathy (swelling of the lymph nodes) was increased. All of these adverse events were mild and resolved in 1-2 days.
The most important issue that worries everyone is the frequency of rare and delayed but serious adverse events. In the older Pfizer / BioNTech vaccinated groups, this was myocarditis, an inflammation of the heart muscle. Before covid, myocarditis was generally more common in the 15-18 age group than in other age groups, approximately 1.8 per 100,000, and led to death in 4-7% of cases. With covid in children, the frequency of myocarditis is 0.02% – 0.08% of cases.
After vaccination began, Pfizer / BioNTech began to notice an increase in the incidence of myocarditis, especially in men younger than 30 years old. For 86 million doses administered, approximately 877 such cases (0.001%) were found. Of these, 829 were hospitalized, 789 have already been discharged, and most have recovered. Fortunately, nobody died. Comparison of the course with normal and “covid” myocarditis showed faster recovery of the heart muscle after vaccine myocarditis.
The risk of vaccine myocarditis is increased in boys aged 12-15 years: 60 cases of myocarditis per million doses administered. The risk goes up after the second dose, so in many countries decided limit yourself to one dose of vaccine to strike a balance between safety and protection. In the United States, 12 million adolescents 12-17 years old have already received the Pfizer / BioNTech vaccine, but the decision on a similar vaccine Moderna so far postponed.
The incidence of common myocarditis in children 5-11 years old is lower than in adolescents, so there is an assumption that vaccine myocarditis will occur with a lower frequency, especially given the reduced dose of the drug.
For and against
As always, after weighing the benefit / risk ratio based on all available information, independent experts in the United States concluded that vaccination of children 5-11 years old can be recommended. Simulations have shown that, depending on the scenario, vaccinating one million children could prevent one to three deaths, more than 60 admissions to intensive care, about 200 hospitalizations and 40-50 thousand cases of illness at the current magnitude of the pandemic.
For those who say that it was not worth worrying about spending so much money on vaccine research and “feeding” the greedy bigpharm, the American epidemiological agency CDC has prepared a slide with previous cases of vaccine registration for children: it turned out that COVID-19 surpasses a number of other diseases, the need for vaccination against which no one doubts.