FDA Approves Pfizer-BioNTech Vaccine for Prevention of COVID-19
By Levi Rickert
WASHINGTON — The U.S. Food and Drug Administration (FDA) on Friday night issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older caused by SARS-CoV-2.
This EUA represents the first vaccine authorized for the prevention of COVID-19. The Pfizer vaccine will arrive in Indian Country this coming week.
The FDA has determined that the Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
In anticipation of the FDA approval of the vaccine, the Indian Health Service (IHS) held a press call with news outlets to inform its distribution approach of the vaccine to Indian Country. The IHS will be distributing to all of its 11 regional programs in the lower 48 states. The distribution of the vaccine to Alaska Native IHS facilities will be sent to the state of Alaska.
"All tribal health programs and urban Indian organizations have chosen their preferred distribution channel for a COVID-19 vaccine. Tribes were provided the option of receiving it either through the IHS or their respective state. 338 IHS direct, tribal health programs, and urban Indian organizations have chosen to receive COVID-19 vaccine from IHS," Rear Adm. Francis Frazier, who is the IHS lead for the COVID-19 Vaccine Task Force.
While Friday's FDA approval announcement was welcome news for Indian Country, as well as the rest of the nation, the approval was only for the vaccine developed by Pfizer, which represents only one-third of the initial purchase by the IHS. The IHS distribution plan calls for two-thirds of the vaccine to come from Moderna, which is yet to be approved by the FDA.
Accordring to the information shared during yesterday's press call, the IHS is expecting to receive an initial allocation of approximately 22,400 doses of the Pfizer vaccine and 46,000 doses of the Moderna vaccine. IHS supports CDC and the Advisory Committee on Immunization Practices recommendations for vaccine release, including prioritization of health care workers and residents of long-term-care facilities.
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