Pfizer Prepares To Seek U.S., EU Approval For Its Covid Vaccine In Kids As Young As Five

Pfizer and BioNTech plan to ask regulators to give their Covid-19 vaccine emergency authorization for use in kids aged five and up, the companies said Monday, after announcing the first set of promising results from a major vaccine trial in this age group.gettyEarly findings from the trial, which involved 2,268 children aged five to 11 years old and has not been peer reviewed, showed the vaccine produced a “strong immune response” one month after the second dose, the companies said.

The children were given shots one third the strength of what is used for those aged 12 and up, but the study indicated comparable immune responses to 16 to 25 year olds receiving the standard two-dose regimen, the companies said. The vaccine is “safe” and “well tolerated” in the younger age group, the companies said, and side effects are also similar to those experienced by 16 to 25 year olds, including injection site pain, fever, fatigue and chills.

Pfizer CEO Albert Bourla said the results provide a “strong foundation” for the company to seek authorization for the vaccine’s use in children five to 11 years old, adding it plans to submit the findings to regulators like the U.S. Food and Drug Administration and the European Medicines Agency as soon as possible.

High-level findings from other parts of the trial, which cover children aged six months to five years, are expected by the end of the year, the companies said, and data from the full trial will be submitted for peer review and publication in a scientific journal. 5.3 million. That’s how many children have tested positive for Covid-19 in the U.S. since the pandemic began, as of September 9,

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