Pfizer says it tested children under the age of 12 with a lower dose of COVID vaccine and found it to be safe.
According to the Associated Press, Pfizer conducted testing with children under the age of 12 using a lower dose of its COVID-19 vaccine and found the treatment to be safe.
Pfizer stated on Monday that it would seek approval in the United States to begin delivering the vaccine to children aged 5 to 11 years old, as nationwide worry over the virus’s spread among the unvaccinated intensifies.
The vaccine had previously been given full approval by the US Food and Drug Administration (FDA) for individuals aged 12 and up, leaving those under the age of 12 particularly exposed as schools reopened and pediatric cases soared.
Dr. Bill Gruber, Senior Vice President of Pfizer, said that when testing youngsters aged 5 to 11, the company gave them one-third of the dose provided to older groups and discovered that the younger children produced the same levels of antibodies as teens and young adults who received the full dose.
The vaccination was also proven to be safe for younger children, who had similar or fewer transitory vaccine side effects than teenagers, according to Gruber.
“I believe we’ve found the sweet spot,” he remarked.
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According to Gruber, the businesses plan to file to the FDA by the end of the month for emergency use in this age group, followed by applications to European and British regulators shortly after that.
FDA Commissioner Dr. Peter Marks told the Associated Press earlier this month that once Pfizer submits its research results, his agency will analyze the data “hopefully in a matter of weeks” to determine if the shots are safe and effective enough for younger children.
Scientists want additional specifics, according to an outside expert, but the findings is optimistic.
Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, said, “These topline results are really positive news.” “The amount of immunological response indicated by Pfizer appears to be protective,” according to the company.
Many Western countries have vaccinated children as young as 12 years old so far, pending proof of the correct amount and that it works safely. Cuba began immunizing children as young as two years old with domestic vaccines this week, and Chinese officials have approved two of its brands for use in youngsters as young as three years old.
While they were still children. This is a condensed version of the information.