Pfizer announced, Friday, its desire to test a third dose of the vaccine against the emerging coronavirus in children under the age of five, which may prompt the company to apply for a license for three doses immediately in this unit next year.
As part of an ongoing clinical trial, the US pharmaceutical giant has selected a dose of 3 micrograms per injection for children aged 6 months to less than 5 years. This is ten times lower than the dose given to adults (30 mcg), and also less than the dose for children aged 5 to 11 years (10 mcg).
In children 2 to less than 5 years old, the 10 mcg dose actually caused more fevers than in the older groups, prompting the company to opt for a lower dose.
But with two injections of 3 micrograms, her immune response was shown to be worse than that given to adolescents and young adults by the vaccine.
So Pfizer decided to modify its clinical trial protocol, to include a third dose, to be injected “at least two months after the second,” the company said in a press release (the first two to be injected remain 3 weeks later. The last).
A booster dose has already shown, in older populations, to increase the protection conferred.
This “amendment” should not have any implications for the expected timeline for filing an application for permission for these young children, envisaged “in the second quarter of 2022,” which was announced during a conference call Catherine Janssen, who is responsible for research on vaccines within the group.
Pfizer also announced Friday that it has begun trials in 600 teens between the ages of 12 and 17 to test a booster dose (10 or 30 micrograms).
Currently in the United States, in addition to adults, the stimulant dose is only allowed for adolescents between 16 and 17 years of age.
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