TOPLINE Pfizer says its Covid-19 vaccine is more than 90% effective against infection for children between the ages of 5 and 11, according to briefing documents shared by the Food and Drug Administration (FDA) Friday morning as its regulators prepare to release their opinion on giving the jab to young kids.
The briefing documents included the results of a trial by Pfizer of about 2,250 children who were either given two shots of a low-dose vaccine (about a third of the amount given to teens and adults) or a placebo.
Just three of the children inoculated with Pfizer’s vaccine developed the virus compared to 16 of those who received the placebo, making the vaccine about 90.7% effective.
The trial shored up no safety issues (though it wasn’t large enough to identify cases of rare heart inflammation) and suggested young children given the vaccine develop the same levels of antibodies as teenagers and young adults who received full doses of the vaccine.
The FDA released these documents as its regulators are expected to post online their written assessment of the data that’s been provided by Pfizer as early as Friday morning.
WHAT TO WATCH FOR
The response from the FDA regulators will give critical insight into how the agency will rule in authorizing the vaccine for this demographic. Members of its advisory panel, the Vaccines and Related Biological Products Advisory Committee, are set to meet Tuesday to vote on their recommendations for authorization.
Though it is still extremely rare for young people to die from Covid-19, record numbers of children being hospitalized with the virus during the summer and fall delta wave exacerbated calls to make vaccines available for young children. A study released by the Centers for Disease Control and Prevention (CDC) earlier this week found Pfizer’s jab to be 93% effective at preventing hospitalizations among those between 12 and 18.
By Jemima McEvoy, Forbes Staff