Pfizer Provides US Initial Data on Coronavirus Vaccine in Children Ages 5 to 12

Pfizer and BioNTech announced on Tuesday that they released initial data on the results of the vaccine against coronavirus 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 drug companies said they have shared data from phase 2/3 of their clinical trial with the US Food and Drug Administration for an “initial review” after recently disclosing that two low doses of the vaccine generated 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 to whom he had been immunized with two 30-microgram doses in the overall study.

The request for emergency use in the US for this age group will be made “in the coming weeks,” while the firms have “planned” to request the same from European authorities and other regulators, according to the note.

Pfizer and BioNTech They also said they plan to submit the data from phase 3 of the trial to a scientific peer review later.

The vaccine from these pharmaceutical companies, which is one of the most widely distributed in the world, has been available to adults 12 years and older in the US since May and is the only one approved for adolescents.

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, they 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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