Fauci hopeful kids can get vax by November
Pfizer pushes for emergency use
As Pfizer on Tuesday announced that it has submitted data to the Food and Drug Administration from its coronavirus vaccine trial for kids ages 5 to 11, Dr. Anthony Fauci said “hopefully” children can start getting the vax next month.
The pharma megagiant last week had said its COVID-19 vaccine at a lower dose is safe and effective for kids who are 5 to 11 years old. Pfizer has now sent its trial results to the FDA in the hopes of receiving emergency use authorization to get kids vaccinated ahead of the winter.
After Tuesday’s announcement, Fauci said kids could potentially start getting the vax by the end of October.
“Well the FDA takes very seriously the importance of getting vaccines shown to be safe and effective in children to getting it into the arms of children, in this case children from 11 down to 5,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, said on MSNBC.
“The FDA, you never want to get ahead of their judgment, but I would imagine in the next few weeks they will examine that data and hopefully they’ll give the OK so that we can start vaccinating children, hopefully before the end of October,” added Fauci, who’s the chief medical adviser to President Joe Biden.
This vax development for kids comes as pediatric coronavirus cases spike in the U.S. amid the delta variant. More than 5 million U.S. children have tested positive for the virus since the start of the pandemic, and child cases have increased significantly since the summer — with nearly 500,000 reported cases in the previous two weeks.
The Pfizer vax trial used a two-dose regimen of 10 micrograms administered 21 days apart, a smaller dose than the 30-microgram dose used for people 12 and older.
The antibody responses in the participants given 10-microgram doses were comparable to those recorded in a previous Pfizer study in people 16 to 25 years of age immunized with 30-microgram doses.
“In the trial, which included 2,268 participants 5 to <12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10-microgram doses,” Pfizer said in a statement.
Trial results in children under 5 years of age are expected as soon as later this year.
“The FDA takes seriously the importance of getting vaccines shown to be safe and effective in children.”
DR. ANTHONY FAUCI Chief Medical Adviser