How did the FDA determine the safety and effectiveness of the COVID-19 vaccines for use in kids?
For children ages 5 through 11, the
FDA
reviewed a vaccine study of more than 4,600 children in this age range. Of this group, about 3,100 were given the Pfizer-BioNTech
COVID-19 vaccine. The other children were given an inactive (placebo) shot. Children who were given the vaccine were monitored for side effects for at least two months after the second dose. Side effects were generally mild to moderate.
The
FDA
also took an early look at cases of
COVID-19
that occurred one week after children were given a second dose of the vaccine. None of the children in this analysis had been previously diagnosed with
COVID-19. Among 1,305 children given the vaccine, there were three cases of
COVID-19. Among 663 children given the placebo, there were 16 cases of
COVID-19. The results suggest that the vaccine is about 91% effective in preventing
COVID-19 in this age group.
For children ages 12 through 15, the
FDA
reviewed a vaccine study of more than 2,200 U.S. children in this age range. Of this group, about half were given the Pfizer-BioNTech
COVID-19
vaccine. The other children were given a placebo shot. A week after the second dose was given, there were no cases of
COVID-19 in the 1,005 children given the Pfizer-BioNTech vaccine.
Among 978 children given the placebo, there were 16 cases of
COVID-19. None of the children had previously been diagnosed with
COVID-19. The results suggest that the vaccine is 100% effective at preventing the
COVID-19
virus in this age group. Also, a portion of the children in each age group were monitored for safety for at least two months after being given the second dose of the
COVID-19 vaccine.
To find out the effectiveness of the Pfizer-BioNTech vaccine for children ages 6 months through 4 and the Moderna
COVID-19
vaccine for children ages 6 months through 17 years old, the
FDA looked at the immune responses of children in these age groups after they were fully vaccinated.
The
FDA compared those responses to the immune responses of young adults who'd been given higher doses of the same mRNA vaccine.
As with the other vaccines, side effects were recorded. Some of the children were monitored for safety for at least two months after being fully vaccinated.
To find out how well the Novavax
COVID-19
vaccine worked, the
FDA
reviewed data on 2,232 people ages 12 to 17. The research suggests that the vaccine was about 78% effective at preventing
COVID-19 disease in this age group.