Pfizer submits data to FDA on COVID-19 vaccine in kids ages 5 to 11

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Pfizer-BioNtech has submitted data from a late-stage trial of its COVID-19 vaccine in children ages 5 to 11 to the US Food and Drug Administration, saying the companies will formally seek emergency approval in the coming weeks. Looking forward to submitting a request for “

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Phase 2/3 trial data collected from more than 2,2600 participants will be reviewed by the FDA. Company officials said the companies are expected to follow up with a formal submission in the coming weeks to request emergency use authorization for the COVID-19 vaccine.

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The Pfizer COVID-19 vaccine is currently available in the US to those 12 and older, leaving many young children still vulnerable amid the rapid spread of the delta version of the coronavirus. With millions of children now back in school and the Delta variant causing a huge surge in pediatric infections, many parents are anxiously waiting to be vaccinated for their young children.

In a statementPfizer said its two-dose vaccine demonstrated it was safe with similar or less temporary side effects, and induced a “strong neutralizing antibody response” in a younger age group.

related: Pfizer is studying oral drug to prevent COVID-19 in people who

For primary school-aged children, a much lower dose was tested—now one-third of the amount given in each shot given. Yet after their second dose, children ages 5 to 11 had coronavirus-fighting antibody levels as strong as teens and young adults getting the regular-strength shots.

FILE – A 12-year-old boy receives a dose of the Pfizer-BioNTech COVID-19 vaccine on September 24, 2021 in Espoo, Finland. (Photo by EMMI KORHONEN/Lehtikuva/AFP via Getty Images)

According to the American Academy of Pediatrics, while children have a lower risk of serious illness or death than older people, more than 5 million children in the US have tested positive for COVID-19 and at least 460 have died. Has been. Cases in children have risen as the delta variant has swept across the country.

About 182 million Americans have been fully vaccinated, or just 55% of the total population, according to Data from the US Centers for Disease Control and Prevention. Three-quarters of those 12 and older — the age eligible for vaccination — received the first dose.

As new COVID-19 cases and hospitalizations have risen in recent months, the vast majority of both figures are unconvincing, US health officials say. And all three COVID-19 vaccines in the US offer strong protection against serious illness, hospitalization, and death, despite the extra-infectious delta variant that led to the rise in cases.

related: ‘Please do the right thing’: Biden gets COVID-19 booster shot on camera on Monday

This story was reported from Cincinnati. The Associated Press contributed.


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