Covid-19 Children under 12 years of age lead the incidence of Covid-19 in the absence of vaccines for them
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The Pfizer / BioNTech Covid-19 vaccine is "safe" and "well tolerated" by children between the ages of five and eleven, and the right dose triggers a "robust" immune response, according to the results of a study announced Monday. Business.
The two companies
plan to present the data to the authorities "as soon as possible,"
according to a statement, in which it is stated that the immune response was "comparable" to that observed in young people aged 16 to 25 who received a higher dose of the vaccine.
This is the first clinical data for this age group.
Vaccines based on Pfizer / BioNTech and Moderna messenger RNA technology have been approved by the European Medicines Agency (EMA) and the US FDA for use in children over 12 years of age.
Due in part to the spread of the Delta variant,
"Since July, pediatric cases of Covid-19 have increased by 240% in the United States
, underscoring the need for vaccination," commented Pfizer CEO, Albert Bourla, regarding the data as a "solid basis for the license application".
The
side effects
of the vaccine, dosed at 10 micrograms per injection compared to the usual 30 micrograms for older people, are "generally
comparable" to those seen in people 16 to 25 years old
, the two laboratories note.
These are the partial results of a study
carried out with 4,500 children between 6 months and 11 years old
in the United States, Finland, Poland and Spain.
The two companies hope to publish "in the fourth quarter" the results of the age group 2 to 5 years, as well as the group 6 months to 2 years, which received two injections of 3 micrograms.
The study on children under 12 years of age for the Moderna vaccine is ongoing.
In Israel, children between the ages of 5 and 11 at risk of serious complications from Covid-19 have been vaccinated since August 1.
It is a "special authorization" without waiting for clinical data, and each injection is "studied on a case-by-case basis," according to the Ministry of Health.
According to the criteria of The Trust Project
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