Vaccinating children between 5 and 11 years old, Pfizer asks for the ok to use
From the data of the experiment, just concluded, it emerged that a third of the dose will be enough for the little ones
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The pharmaceutical company Pfizer has asked the US FDA to authorize its Covid vaccine for the age group between 5 and 11 years. A request that affects about 28 million children.
The two partner companies Pfizer and BioNTech already announced in recent days that they had presented the data of the phase 2/3 study on the anti-Covid vaccine in this age group to the US regulatory body FDA.
From the data of the experiment, just concluded, it emerged that for the little ones a third of the dose will be enough: 10 micrograms instead of 30, but the vaccination cycle will still be complete at two doses and 21 days apart, as for adults.
"The vaccine - the companies specified - has shown a favorable safety profile" and "strong responses" in terms of "neutralizing antibodies, using a two-dose scheme of 10 micrograms", equal to one third of the dose that is inoculated to the larger.
The data are considered "comparable to those recorded in a previous Pfizer-BioNTech study, conducted on people aged between 16 and 25 years and immunized with doses of 30 micrograms".
The companies also specified that the proposed dosage for children was "carefully selected as the preferred dose for safety, tolerability and immunogenicity in children between the ages of 5 and 11".
(Unioneonline / vl)