Pfizer filed an EUA. When will kids be able to get vaccinated?
Pfizer has filed an emergency use authorization application with the Food and Drug Administration for children ages 5 to 11 to receive the COVID-19 vaccine.
Cases, hospitalizations and deaths in children have all increased during the Delta variant surge. Just short of 6 million children have tested positive for the coronavirus in the United States since the start of the pandemic, representing 16.2% of all cases, according to the American Academy of Pediatrics. Children represented more than a quarter of all COVID cases in America for the last week of September.
While the death rate in children is low — 0.03% or lower, the AAP reported — they still risk long COVID symptoms and the potentially deadly inflammatory condition MIS-C, along with the chance of transmitting the disease to more vulnerable adults. More than 400 children between the ages of 5 and 18 have died of COVID-19 in the United States, along with 181 children under 5.
In comparison, Pfizer says its vaccine is safe and effective in children 5 to 11. (Children 12 to 17, as well as all adults, are already able to be vaccinated.) The dosage is one-third of the amount in the standard adult vaccine, but resulted in equal antibody levels in children compared to teenagers and young adults. Children experienced similar or fewer temporary side effects like sore arms and fevers from the vaccine than teenagers did, a Pfizer scientist told the Associated Press.
Pfizer announced the news about the emergency use application in a tweet Thursday morning.
Pfizer formally applies to the FDA for use of its COVID-19 vaccine in children ages 5 to 11. If regulators agree, shots could begin within weeks.
So what does this mean for when kids can get vaccinated?
There is no timetable for how long the process could take. Last year, Pfizer submitted its application for emergency use of the vaccine for adults on Nov. 20, and it was OK’d on Dec. 11 — three weeks later. (The vaccine got full FDA approval this summer.) Pfizer submitted the data for vaccine use in children to the FDA last month, before filing the emergency use application. Right now, it will depend on how quickly the FDA reviews the application and data.
Dr. Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, said he thinks vaccines could be approved and rolled out for children by Halloween. The Associated Press and Wall Street Journal quoted a person familiar with the matter but not authorized to speak publicly who anticipated availability by Thanksgiving or possibly sooner.
Trials for children are still underway by Moderna, which is testing its vaccine in children ages 6 to 11, and Johnson & Johnson, which is testing its version in adolescents ages 12 to 17. Moderna and Pfizer have previously said they have trials planned or in progress for children as young as 6 months. Pfizer said in July that it expects to have data on vaccines for children ages 6 months and older this month or next.
The vaccine verification requirement went into effect at 11:59 p.m. Thursday.
