Pfizer and BioNTech announced on Tuesday that they provided initial data on the results of the vaccine against COVID-19 in children between 5 and 12 years old to the US authorities and said that in the coming weeks they plan to formally request its emergency use for this group.
In a statement, the pharmaceutical companies indicated that they have shared data from phase 2/3 of their clinical trial with the Food and Drug Administration of EE.UU. for an “initial review” after recently disclosing that two low doses of the vaccine elicited a “robust” immune response in children.
Based on initial data, based on testing of nearly 2,300 children ages 5-12, a two-dose 10-microgram regimen of the product had a response “comparable” to that seen in people ages 16-25 at who had been immunized with two doses of 30 micrograms in the general study.
The request for emergency use in EE.UU. for this age group it will be done “in the coming weeks”, while the firms have “planned” to request the same from the European authorities and other regulators, according to the note.
Pfizer and BioNTech They also said they plan to subject the data from phase 3 of the trial to a scientific peer review later.
The vaccine of these pharmaceutical companies, which is one of the most distributed in the world, has been available to adults from 12 years in EE.UU. since May and is the only one approved for teenagers.
The companies said they expect to have immunity and safety data for two other younger age groups, 6 months to 2 years, and 2 to 5 years, as early as the fourth quarter of this year.
Although children are less susceptible to developing severe symptoms of COVID-19, can spread the virus and the situation has become dire for vulnerable people with the face-to-face return to schools of millions of children in the country.
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