FDA grants emergency use of Pfizer vaccine for youths, health officials waiting for CDC recommendations
The fight against the COVID-19 pandemic took another step forward Monday with U.S. Food and Drug Administration granting emergency use authorization of the Pfizer-BioNTech vaccine for people 12 and older.
"The FDA's expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock, M.D., said in a press release. "Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. 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."
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to discuss the emergency use authorization in a meeting Wednesday.
FDA had previously granted emergency use of the Pfizer vaccine to people 16 and older.
The other primary vaccines in the United States, Moderna and Johnson & Johnson/Janssen vaccines, are only approved for people 18 and older, though trials on younger people are underway for those vaccines.
Pfizer and Moderna vaccines each require two doses for full vaccination, while the Johnson & Johnson vaccine requires only one dose.
Moderna announced this week its vaccine has proven effective in children 12 to 18, although it has not been authorized by FDA as yet, and both Moderna and Pfizer are conducting trials on children ages 6 months to 12 years old.
The Pfizer vaccine requires storage at extremely cold temperatures and has had limited availability in this area. It has been administered primarily at Rocky Boy's and Fort Belknap Indian reservations through the federal Indian Health Services, although they have provided access to people from off the reservations including at events in Chinook and Havre.
Rocky Boy Clinic reported it is waiting for the recommendations of the Advisory Committee on Immunization Practices Wednesday before setting out how it will proceed.
Hill County Health Officer Kim Berg, also the public health director at Hill County Health Department, said this morning that the health department also is awaiting the advisory committee's recommendations, which it must follow, but she is hoping to have some Pfizer vaccine at the health department at some point.
"I am working closely with the state on that," she said. "It all depends on the storage requirements for the Pfizer vaccine. The state is also working on having a team come into Hill County and offering Pfizer vaccine clinics. I do not know when this will happen yet, but this is a statewide plan they have going and Hill County will be one of their stops."
Berg said the health department will be working with the state to find a location to use, a date and time and will be helping advertise once it knows more.
Increasing percentage of cases in younger people
The authorization comes as health officials report that confirmed COVID-19 cases include a growing percentage of younger people, including children and teens, which is mirrored in this area.
While the region has not seen a surge in confirmed cases like it did last fall and early winter, more cases are being confirmed than a few weeks ago.
The FDA release said that from March 1 through April 30 approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention.
The release also said children and adolescents generally have a milder COVID-19 disease course as compared to adults, although they can transmit the virus to adults. Officials say immunizing the group also is a priority because as long as the virus continues to spread, more dangerous mutations could arise.
"Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic," Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in the FDA release.
Low vaccination numbers
The rate of people being vaccinated in this area has slowed since the initial rush when the vaccines first became available.
Without including 12- to 15-year-olds, the number of people eligible for vaccination in Hill County was 12,328 on the Monday update of the state tracking map. Of those people, 5,981 had received at least one shot, including 4,736 people fully vaccinated.
In Blaine County the map listed 4,910 residents as eligible, with 2,472 receiving at least one shot, including 1,978 people fully vaccinated.
The number of eligible residents in Chouteau County was 4,545 with 1,653 people receiving at least one shot, including 1,405 fully vaccinated.
And 1,917 residents were listed as eligible in Liberty County, with 634 people receiving at least one shot, including 600 people fully vaccinated.
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