Pfizer and BioNTech said Tuesday that their COVID-19 vaccine is more than 90% effective in children ages 5 to 11, based on early data from a clinical trial..
The companies said they plan to submit the data to the U.S. Food and Drug Administration (FDA) and other regulators as soon as possible. If authorized, the vaccine could be available to children in this age group as early as this fall..
The clinical trial involved more than 2,200 children ages 5 to 11. The children received two doses of the vaccine, 21 days apart. The vaccine was found to be safe and well-tolerated, with the most common side effects being pain at the injection site, fatigue, and headache..
The efficacy of the vaccine was determined by comparing the number of children who developed COVID-19 in the vaccine group to the number of children who developed COVID-19 in the placebo group. Of the children who received the vaccine, only three developed COVID-19, compared to 16 children who received the placebo. This means that the vaccine was 90.7% effective in preventing COVID-19 in children ages 5 to 11..
The results of this clinical trial are consistent with the results of previous clinical trials that have shown the Pfizer-BioNTech vaccine to be safe and effective in adults and adolescents. The vaccine is now authorized for use in people ages 12 and older in the United States..
The authorization of the Pfizer-BioNTech vaccine for children ages 5 to 11 would be a significant step in the fight against the COVID-19 pandemic. Children are more likely to spread the virus to others, and they can also develop serious complications from COVID-19. Vaccinating children would help to protect them from the virus and slow the spread of the pandemic..
The FDA’s decision on whether to authorize the Pfizer-BioNTech vaccine for children ages 5 to 11 is expected in the coming weeks..
