It's official: Pfizer and BioNTech have now formally asked the Food and Drug Administration to grant an emergency use authorization for a COVID-19 vaccine to be given to children aged 5 to 11 years. If granted, it will close another big gap in getting the United States closer to "herd immunity," a level at which so many Americans are vaccinated against the COVID-19 virus that the virus has far fewer chances to spread.
The New York Times reports that a decision from the FDA is "expected between Halloween and Thanksgiving."
Pfizer turned over the data for its Phase 2/3 trials for children between 5 and 12 in late September, and there's heavy pressure on both regulators and the drug manufacturers to speed a children's vaccine to the public as swiftly as possible. Schools have become pandemic hot zones, especially in Republican-led states that have scoffed at or tried to ban mask mandates outright.
While children have historically been faring much better than adults, after COVID-19 infection, there's signs the delta variant is undoing some of that disparity. "Better" is also a relative term: tens of thousands of American children have been hospitalized due to their infections, and deaths are mounting.
Furthermore, as schools become major pandemic hotspots, the children who get infected are bringing the virus home and spreading it to their families and other adults. That's among the top reasons some states are already planning to make the vaccine mandatory for school attendance if one is approved.
Getting emergency use authorization for children and widespread availability of children's doses before the holidays may be a tricky proposition at this point. The FDA has a lot on its plate, and drug reactions in children can be so different from those in adults that merely approving a "smaller" dose is not as simple a task as it may sound. However, all signs so far point to a vaccine becoming available for American children as young as 5 within the next few months.
The New York Times reports that a decision from the FDA is "expected between Halloween and Thanksgiving."
Pfizer turned over the data for its Phase 2/3 trials for children between 5 and 12 in late September, and there's heavy pressure on both regulators and the drug manufacturers to speed a children's vaccine to the public as swiftly as possible. Schools have become pandemic hot zones, especially in Republican-led states that have scoffed at or tried to ban mask mandates outright.
While children have historically been faring much better than adults, after COVID-19 infection, there's signs the delta variant is undoing some of that disparity. "Better" is also a relative term: tens of thousands of American children have been hospitalized due to their infections, and deaths are mounting.
Furthermore, as schools become major pandemic hotspots, the children who get infected are bringing the virus home and spreading it to their families and other adults. That's among the top reasons some states are already planning to make the vaccine mandatory for school attendance if one is approved.
Getting emergency use authorization for children and widespread availability of children's doses before the holidays may be a tricky proposition at this point. The FDA has a lot on its plate, and drug reactions in children can be so different from those in adults that merely approving a "smaller" dose is not as simple a task as it may sound. However, all signs so far point to a vaccine becoming available for American children as young as 5 within the next few months.