By Staff Reporter |
Governor Katie Hobbs has rejected the Federal Drug Administration’s restrictions on the new COVID-19 vaccine.
The FDA limited administration of the 2025-26 formula for the COVID-19 vaccine to individuals 65 and older. However, last week, Hobbs issued an executive order expanding access to anyone over the age of six months old.
The governor claimed she issued the executive order to ensure Arizonans’ health and safety.
In explanations of its August announcement to the media, the FDA explained it recommended limitations on the newest vaccine formula in order to address safety and efficacy concerns.
“The American people demanded science, safety, and common sense,” said Secretary Robert Kennedy. “This framework delivers all three.”
In a May report, FDA Commissioner Marty Makary and FDA Center for Biologics Evaluation and Research Director Vinay Prasad recommended randomized clinical trials to prove the vaccines’ safety and efficacy.
The FDA did recommend allowing immunization to those as young as six months on the condition that they have “at least one underlying condition” rendering them “at high risk for severe outcomes from COVID-19.”
The CDC defines these underlying conditions to include: Asthma; cancers; cerebrovascular disease; chronic kidney disease; chronic lung diseases limited to bronchiectasis, COPD, interstitial lung disease, pulmonary embolism, pulmonary hypertension; chronic liver diseases limited to cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis; cystic fibrosis; diabetes; heart conditions such as heart failure, coronary artery disease, or cardiomyopathies; HIV; mental health conditions limited to mood disorders including depression and schizophrenia spectrum disorders; neurologic conditions limited to dementia and Parkinson’s disease; obesity; physical inactivity; pregnancy; primary immunodeficiencies; smoking, current and former; solid organ or blood stem cell transplantation; tuberculosis; use of corticosteroids or immunosuppressive medications; epilepsy; hemophilia; sickle cell disease; and substance use disorder.
Despite the conflict with FDA recommendations, the Arizona Department of Health Services (ADHS) teamed up with Hobbs to expand eligibility to those as young as six months in Arizona.
ADHS determined outside FDA recommendations that the the Moderna Spikevax is appropriate for children aged six months to 11 years, the Pfizer BioNTech (Comirnaty) is appropriate for children aged five to 11 years, and the Moderna (Spikevax), Novavax (Nuvaxovid), and Moderna (mNEXSPIKE) are appropriate for children 12 years and older.
Dr. Richard Carmona, ADHS Public Health Medical Advisor and former U.S. Surgeon General, indicated the 2025-26 formulation was as safe and effective as prior formulations.
“Vaccines are one of the most important tools we have to protect our communities,” said Carmona. “The COVID-19 vaccine has proven to be safe and effective at preventing severe illness, hospitalization, and death. Vaccines help us limit the spread of disease and reduce pressure on our healthcare system.”
ADHS interim director Sheila Sjolander called the updated FDA recommendations a “confusion” that the governor and ADHS clarified.
“We understand the federal changes have caused confusion about eligibility for vaccination,” said Sjolander. “We are committed to keeping the public updated on our recommendations throughout this respiratory season. ADHS has updated our website with the latest information on what the standing order means for Arizonans.”
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