October 22, 2021 – Pfizer says its children’s vaccine is 90% effective in preventing COVID-19 infections.
The Pfizer vaccine for children aged 5 to 11 is 10 micrograms, which is about a third of the dose given to adolescents and adults.
In data presented to the FDA ahead of the agency’s review of its pediatric injections, the company described interim results from two ongoing studies testing the safety and effectiveness of its 10 microgram injections.
Data on the effectiveness of the vaccine come from a study involving more than 2,000 children aged 5 to 11 years. Two-thirds of the children were randomly assigned to receive a child-sized dose of Pfizer-BioNTech vaccine, while the other third were classified as placebo. group.
The study began when the Delta variant became dominant in the world. By the first week of October, 16 participants in the placebo group had acquired symptomatic and laboratory-confirmed COVID-19 infection, compared with only three who contracted COVID in the vaccinated group.
According to the company’s analysis of its own studies, the side effects seen in the study were almost all mild. The most frequently reported side effect was pain at the injection site. Children in the vaccine group also had fatigue, headache, fever, and chills at higher rates than those seen in the placebo group. These were more frequent after the second dose. Some skin reactions were seen in the study, such as itching and rash, but most of them were mild and went away within days.
Children could also have swollen lymph nodes after their vaccinations, as adults sometimes do, but these reactions were temporary.
A child developed a tic, a recurrent involuntary muscle contraction or vocal sound, which occurred one week after his second dose of the vaccine. It was found by the study researchers to be related to the vaccine. The company said it was missing at the time of the study’s publication.
Reassuringly, no cases of heart inflammation called myocarditis were found in the study. Myocarditis is rare, occurring in about 36 people per 100,000 vaccinated, according to the CDC.
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