Comirnaty , the Pfizer / BioNTech COVID-19 vaccinum , seems to be well tolerated and engender a robust immune answer in youngster between 5 and 11 , according to the drug makers . They contrive to relegate their outcome for health regulator ' consideration as soon as possible .
The determination total from a Phase2/3 clinical test that included 2,268 participant who were 5 to 11 old age of age . They test a two - dose regimen for child , three week apart . Each dose is one - third of what has been given to anyone over the eld of 12 . One calendar month after the 2nd dose , the resistant response from the shaver was exchangeable to the one seen from teens and young adult , who were used as a dominance chemical group .
“ We are proud of to be able-bodied to submit information to regulatory authorities for this group of school - age children before the starting signal of the winter time of year , ” Dr Ugur Sahin , CEO and co - founder of BioNTech , said in astatement . “ The safety profile and immunogenicity information in shaver aged 5 to 11 years inoculate at a lower dose are uniform with those we have observed with our vaccine in other older populations at a higher dose . ”
During the current wave of COVID-19 infection spreading through the US , a much higher number of child have been infect . In amount , the US has had almost5.3 million casesof COVID-19 in children , with over 243,000 young cause in the first week of September alone . That week and the previous one were responsible for an increment of 10 percent in the number of case in children since the start of the pandemic .
“ Over the past nine month , hundreds of millions of people years 12 and older from around the humankind have received our COVID-19 vaccinum . We are eager to extend the tribute afford by the vaccinum to this new population , subject to regulative mandate , especially as we track the feast of the Delta variant and the substantial menace it impersonate to children , ” allege Albert Bourla , Chairman and Chief Executive Officer , Pfizer .
“ Since July , paediatric cases of COVID-19 have risen by about 240 percent in the US – underscoring the public health need for inoculation . These test results provide a strong base for seeking authorization of our vaccine for children 5 to 11 old age honest-to-god , and we contrive to submit them to the FDA and other regulator with urgency . ”