vaccine effective over 90 percent in children between 5 and 11 years –

from Laura Cuppini

The company presented the results of a study involving over 2,000 participants to the American FDA. The decision of the Advisory Committee is expected next week

The Food and Drug Administration (FDA) decision on the possibility of vaccinating children under 12 against Covid is expected in the next few days. The Pfizer manufacturer presented to the American body the results of a study on 2,268 children between 5 and 11 years: the effectiveness in preventing symptomatic infection was 90.7%. For children, one third of the dose intended for over 12s and adults is enough, or 10 micrograms compared to 30: the trial shows that the dosage is safe and does not present the risk of serious side effects. Of the 2,268 children recruited, double the number of children received the vaccine compared to the placebo group: 16 children contracted Covid in the control group, while 3 of the vaccinated children got sick. Pfizer submitted the first data to the FDA in view of a meeting in program next week, in which the Advisory Committee will decide whether to recommend Comirnaty (the vaccine produced by Pfizer and BioNTech) in the under 12 bracket. If the FDA gives the green light, the ball will pass to the Centers for disease control and prevention (Cdc), which will provide operational indications for the vaccination campaign. The application for authorization will also be submitted to the European Medicines Agency (Ema).

Studies also on the very young

In the United States, the Delta variant has brought the number of pediatric hospitalizations (including in intensive care) to a level never seen during the pandemic, especially following the reopening of schools. Full approval of the Pfizer vaccine by the FDA in August affected those over 16. Children ages 12 to 15 can still receive it with an emergency clearance. Moderna’s vaccine can also be used for ages 12 and up. In addition, Pfizer and BioNTech have initiated studies on children aged between 6 months and 2 years and between 2 and 5 years. The results are expected, the two companies explained, before the end of the year. In children under 5, from early studies, it seems that 3 micrograms, one-tenth of the standard dose, are enough. And there are those who went ahead: Israel has given special permission to vaccinate 5-11 year olds who are at significant risk of serious illness or death from Covid, using Pfizer at the lowest dosage.

The risks associated with Covid

As known, children have a low risk of becoming seriously ill with Covid, but a small percentage develop the potentially dangerous multisystem inflammatory syndrome (MIS-C). Others suffer from long Covid and have persistent symptoms for months. Furthermore, even if they often become infected asymptomatically, they can infect teachers, parents, grandparents and especially immunosuppressed people who (despite the vaccine) risk death from Sars-CoV-2. The FDA is also evaluating the (very rare) risk of post vaccine side effects in children and young people, in particular the focus is on cases of myocarditis and pericarditis. A large Israeli study, based on the medical records of two million over 16s, showed that the odds of developing this heart inflammation are much higher in children who contract Covid than in those who are vaccinated.

October 22, 2021 (change October 22, 2021 | 17:53)


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