The quality was released arsenic the institution has submitted information to the U.S. Food and Drug Administration (FDA). Pfizer/BioNTech is presently seeking exigency authorization to administer the coronavirus vaccine to children.
Children participating successful the objective proceedings received a dose of 10 micrograms, an magnitude that was one-third of the big dose.
A full of 2,268 children from ages 5 to 11-years-old were included successful the trial. Twice arsenic galore were fixed the child-level dose of the vaccine compared to others who received a placebo. Among those who received the placebo, 16 tested affirmative for COVID-19. Three cases were recorded among those who were administered the proceedings vaccine.
Pfizer’s objective proceedings successful those 5 to 11 years aged was not chiefly designed to measurement efficacy against the virus. Instead, it compared the magnitude of neutralizing antibodies induced by the vaccine successful the children to the effect of older recipients successful their big trial. The institution claims its COVID-19 vaccine usage successful children 5-11 years aged showed a 90.7 percent efficacy rate.
The Mayo Clinic has besides said that determination person been reported cases of myocarditis and pericarditis aft COVID-19 vaccination, “particularly successful antheral adolescents and young adults property 16 and older.” Myocarditis is the inflammation of the bosom muscle, portion pericarditis is the inflammation of the lining extracurricular the heart.
A White House Fact Sheet released Wednesday provided an update connected precocious plans for COVID-19 vaccinations for children 5 to 11.
“The imaginable authorization of the archetypal COVID-19 vaccine for children ages 5-11, which is presently nether information by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), would beryllium different large milestone successful our efforts to physique connected this historical advancement and support adjacent much Americans,” the information expanse said.
The program included respective steps successful anticipation of the vaccine’s support for young children. First, the Biden medication “has procured capable vaccine to enactment vaccination for the country’s 28 cardinal children ages 5-11 years old.”
Another absorption successful the information expanse said that much than 25,000 pediatric and superior attraction supplier sites volition beryllium made disposable to administer the coronavirus vaccines to children.
The plan’s 3rd absorption emphasized gathering nationalist trust. An acquisition effort for parents and families volition question to supply elaborate accusation regarding vaccines and the risks of COVID-19 arsenic portion of the effort.
The FDA met earlier this month to sermon coronavirus vaccines for younger children. Another gathering is expected adjacent week to sermon the latest accusation from Pfizer/BioNTech, though details person not yet been confirmed.
For now, the vaccines stay unauthorized for usage among young children.
“The FDA has not yet authorized a COVID-19 vaccine for children 5 to 11 years of age, and CDC’s ACIP has not yet made a proposal connected vaccinating this property group,” the Centers for Disease Control and Prevention (CDC) website notes.
Even if the Pfizer/BioNTech vaccine is soon approved, galore American parents volition person concerns oregon take not to person their children vaccinated. The contention whitethorn proceed to pb to further concerns, specified arsenic the recent walkout successful California aft Democrat Gov. Gavin Newsom added a caller request for children 12 and older to beryllium vaccinated to be nationalist schools successful the state.
According to the CDC, since April, determination has been an increase successful reports of some myocarditis (heart inflammation) and pericarditis (inflammation of the insubstantial surrounding the heart) aft COVID-19 vaccination with the Pfizer-BioNTech and Moderna vaccines, peculiarly successful adolescents and young adults.
Reuters and Jennifer Margulis contributed to this report.
Christopher Burroughs reports connected breaking quality for The Epoch Times.