Topline
Pfizer claims its Covid-19 vaccine is over 90% effective against infection in children aged 5-11 years, according to briefing documents that were shared by FDA Friday morning. This comes as the FDA prepares to release its opinion on the vaccination for young children.
A child has been vaccinated. AFP via Getty Images
The Key Facts
Briefing documents contained the results of Pfizer's trial of approximately 2,250 children. They were given either two shots of a low dose vaccine (about one-third of what is given to teenagers and adults) or a placebo. The vaccine was 90.7% effective, with only three children who were inoculated using Pfizers vaccine contracting the virus and 16 who were given the placebo. Although the trial did not identify any cases of rare heart inflammation, it showed that there were no safety concerns. It also suggested that young children who have been given the vaccine will develop antibodies similar to teenagers or young adults who had received the full dose. These documents were released by the FDA as regulators of Pfizer are expected to post online their written assessments of the data as soon as Friday morning.
What to Watch
The FDA regulators' response will provide crucial insight into the FDA's decision to approve the vaccine for this population. Members of the FDA's advisory panel, the Vaccines and Related Biological Products Advisory Committee (Vax) will meet Tuesday to discuss their authorization recommendations.
Important Background
Although it is rare for young people with Covid-19 to die, there were record numbers of Covid-19-infected children hospitalized during the fall and summer delta waves. This has prompted calls for vaccines to be made available to young children. The Centers for Disease Control and Prevention (CDC), released a study earlier this week that found Pfizers jab 93% effective in preventing hospitalizations for children aged 12-18.
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Study by CDC reveals that Pfizers' Covid Vaccine 93% is Effective in Preventing Teen Hospitalizations
Research by Forbes: Vaccinated Teens are 90% less likely to contract Delta Variant in the First Few Weeks after their Second Dose.
Here's How the White House Will Distribute Children's Covid Vaccines. (Forbes).
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