In a new document released ahead of a key meeting of the US Food and Drug Administration's vaccine advisors, Pfizer says its vaccine is safe and 90.7% effective against Covid-19 in children aged 5 to 11.
See also: Pfizer vaccine: Third dose for people over 65 & at high risk
See also: Pfizer COVID-19: Vaccine receives full FDA approval
In the trial, which included about 2,000 children, there were three cases of Covid-19 among the group that received the vaccine and 16 cases in the placebo group. In the trial, twice as many children received the vaccine than the placebo.
Pfizer/BioNTech is requesting emergency use authorization from the FDA for a two-dose regimen for children ages 5 to 11. The two doses would be administered three weeks apart.
Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 was safe and produced a “robust” antibody response in children aged 5 to 11. The trial included 2,268 participants aged 5 to 11. The participants’ immune responses were measured by looking at the levels of neutralising antibodies in their blood and comparing those levels to a control group of people aged 16 to 25 who were given a two-dose regimen with the higher dose of 30 micrograms. Pfizer said the levels were comparable to older adults who received the higher dose, demonstrating a “robust immune response in this group of children one month after the second dose”.
See also: Pfizer & Moderna: Vaccine studies begin in children aged 5 to 11
The FDA's Advisory Committee on Vaccines and Related Biological Products is scheduled to meet on Oct. 26 to discuss whether to recommend the vaccine for approval for ages 5 to 11.
If approved, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people aged 16 and older and has an EUA for people aged 12 to 15.
Source of information: edition.cnn.com
