The Food and Drug Administration said Monday that children 12 to 15 years old are now eligible to receive the Pfizer/BioNTech COVID-19 vaccine as it expanded its emergency use authorization. The expanded approval offers a a way to protect the nation’s adolescents before they head back to school in the fall, potentially paving the way to return to more normal activities.
Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for the two-dose vaccine for 12-15 year-olds. An announcement is expected Wednesday.
Dr. Janet Woodcock, the acting FDA commissioner, said the expansion “brings us closer to returning to a sense of normalcy.”
Until now, the Pfizer vaccine had only been authorized for people 16 or older. Pfizer asked the FDA to broaden its emergency use authorization after conducting clinical trials finding “100% efficacy and robust antibody responses” in study participants 12 to 15. The agency noted there were no cases of COVID-19 among fully vaccinated adolescents compared with 16 among kids given dummy shots. Researchers also found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.
Pfizer’s request for an emergency use authorization for its COVID 19 vaccine was first granted in December. Federal approval to include children as young as 12 in its vaccine trial was given in October.
All three makers of US authorized vaccines – Moderna, Pfizer, and Johnson and Johnson – are studying the safety and efficacy of their vaccines in children, some as young as 6 months.
J&J said last week that it will “initially test” a “small number of adolescents” and expand it from there “if initial data shows an acceptable safety profile.”
Those expanded trials started last month when J&J vaccine shots were given to teens from 16 to 17. If all goes well, the trial will include kids as young as 12, the company said.
Pfizer said it won’t be ready to ask the FDA for emergency use authorization expansions for kids younger than 12 until September. One request would cover children from two to five years old; a second would apply to ages five to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until near the end of this year.
Pfizer and BioNTech said they have the capacity to make up to 2.5 billion doses in 2021, and at least 3 billion in 2022.
Pfizer also asked the FDA to approve a change that would allow its vaccine to be stored at common refrigerator temperatures of two to eight degrees Celsius (36-46 degrees Fahrenheit) for up to four weeks. This move could potentially boost vaccine availability.
This is a departure from the ultra-cold temperatures of around -70 degrees Celsius (-94 degrees Fahrenheit) that these vaccines would need in general. The company loosened that requirement a bit in February to accommodate common freezer temperatures for up to two weeks.
Pfizer Chairman and CEO Albert Bourla told investors in a conference call last week that they have have shipped some 430 million doses to 91 countries and territories so far.