The Food and Drug Administration on Monday said children aged 12-15 are now eligible to receive the Pfizer vaccine, “bringing us closer to returning to a sense of normalcy.”
Clinical trials found “100% efficacy and robust antibody responses” in study participants who were 12 to 15.
Vaccine advisers to the US Centers for Disease Control and Prevention will meet Wednesday to discuss if and how the vaccine should be recommended for use in the younger age group, and CDC Director Dr. Rochelle Walensky will make the final recommendation. Shots could be going into arms as soon as Thursday.
Pfizer said it won’t be ready to ask the FDA for new emergency use authorization expansions for kids younger than 12 until September. One such request would cover children from 2 to 5 years old; a second would apply to ages 5 to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until the fourth quarter of this year.
Pfizer also recently asked the FDA to allow its vaccine to be stored at common refrigerator temperatures of 2 to 8 degrees Celsius (roughly 36 to 46 degrees Fahrenheit) for up to four weeks, submitting its data at those temperatures on April 30. The company loosened the guidelines in February, saying the vaccines could safely be kept at typical home freezer temperatures, -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), for up to two weeks.
This may help in distribution to doctors’ offices.
“We feel that primary care is going to have a real role with the folks who are a little bit hesitant or just need some questions answered,” said one pediatrician in North Carolina. “Maybe the community, for whatever reason, trusts their family doctor or their pediatrician more than they trust, for example, a corporate pharmacy.”