vaccine appears safe and effective for children ages 5 to 11
On September 20, Pfizer released information that phase 2/3 trials have shown its COVID-19 vaccine to be safe and active for children ages 5 to 11. The vaccine elicited a "sustained" antibody response .
The study involved 2,268 children ages 5 to 11. They received two doses of the vaccine 21 days apart. The doses were 10 micrograms, less than 30 micrograms, which were used in people older than 12 years. "The 10 microgram amount has been sensibly nominated as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 eons old," Pfizer said in a statement .
These levels compare well with those of older adults who
received the highest dose, Pfizer says, demonstrating "a strong invulnerable
response in this cohort of children one month after the second dose."
Pfizer said in a announcement that "the COVID-19 vaccine is well tolerated
and the side effects are broadly comparable to those seen in participants ages
16 to 25." The trial found no cases of myocarditis, a type of heart
inflammation that has been associated with mRNA vaccines, according to a Pfizer
spokesperson .
CNN noted that the study data has not yet been peer-reviewed
or published. These are the first vaccine results seen in this age cluster trendy
the United States .
The company plans to refer the results soon, especially
later this month, to the FDA for emergency use.
“Since July, the number of COVID-19 cases among children in
the United States has increased by approximately 240%, highlighting the need
for vaccines for public health. The results of these trials provide a strong
basis for applying for approval of our vaccine aimed at children ages 5 to 11,
and we plan to urgently submit them to the FDA and other regulatory agencies,
”said Albert Burla, President and CEO of Pfizer .