Pfizer Submits Favorable Initial Data To The FDA On Kids’ COVID-19 Vaccine Trial

An older kid gets immunized in Michigan. Pfizer and BioNTech say they will send an official ask for emergency situation usage permission of the vaccine in children as young as 5 in the coming weeks.

Emily Elconin/Bloomberg through Getty Images

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Emily Elconin/Bloomberg via Getty Images

An older kid gets vaccinated in Michigan. Pfizer and BioNTech state they will submit a formal ask for emergency usage permission of the vaccine in children as young as 5 in the coming weeks.

Emily Elconin/Bloomberg through Getty Images

Pfizer and BioNTech are another step more detailed to seeking permission for kids to get the COVID-19 coronavirus vaccine, submitting data to the Food and Drug Administration that reveals a “robust” antibody reaction and “beneficial” safety outcomes in kids ages 5 to 11 who got the two-dose routine in clinical trials. The companies plan to submit an official ask for emergency-use authorization of the vaccine for that age range “in the coming weeks,” they stated Tuesday. News of the information submission comes a week after Pfizer announced promising outcomes from the trials, which have been closely seen by moms and dads excited to secure their kids from the coronavirus. COVID-19 has actually now killed more than 690,000 individuals in the U.S., with millions more sickened by the illness. The trial, among a number of companies are conducting for kids in 3 various age groups, consisted of 2,268 participants. Kids received two vaccine doses of 10 micrograms– notably smaller than the pair of 30-microgram doses used in an earlier successful trial for people 16 to 25 years of ages. The smaller vaccine dose “was carefully picked as the chosen dosage for safety, tolerability and immunogenicity,” the business stated.

The outcomes of the two trials are similar, the companies stated as they revealed the data submission to the FDA. In a different clinical trial for kids younger than 5, participants are getting 3-microgram dosages of the vaccine. The pharmaceutical business expect to have outcomes of trials for kids from 6 months approximately 2 years of ages and from ages 2 to 5 “as quickly as the 4th quarter of this year.”

Pfizer and BioNTech are another step better to looking for permission for young children to receive the COVID-19 coronavirus vaccine, submitting information to the Food and Drug Administration that reveals a “robust” antibody reaction and “beneficial” security outcomes in kids ages 5 to 11 who received the two-dose program in medical trials. News of the data submission comes a week after Pfizer revealed appealing results from the trials, which have been closely viewed by moms and dads excited to protect their kids from the coronavirus. Children received 2 vaccine dosages of 10 micrograms– notably smaller sized than the set of 30-microgram doses utilized in an earlier successful trial for people 16 to 25 years old.

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