BAKERSFIELD, Calif. (KERO) — Kern Medical announced it will offer pre-COVID drug EVUSHELD starting Tuesday to patients who qualify.
California designated Kern Medical as the site in Kern County to administer the medication.
“EVUSHELD comprises two long-acting monoclonal antibodies which now have Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to be administered as separate injections given one right after the other during a single visit. Patients should speak to their doctor to evaluate if they qualify for EVUSHELD.“
People who qualify for EVUSHELD must meet specific eligibility criteria and must not have a history of allergic reaction to any component of the medication. Medical professionals are required to fill out a qualifying survey on behalf of the patients. If patients qualify, they will be contacted to schedule an appointment based on eligibility.
The FDA approved EVUSHELD on Dec. 8th, 2021, for people who have a moderate to severely compromised immune system or have a history of adverse reactions to a COVID vaccine or its components. The drug is only for people who aren't currently infected or who weren't recently exposed to someone with COVID.
“Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
FDA steps for Emergency Use Authorization (EUA)
According to the FDA, an issuance of an EUA requires several steps. First, one of the four following determinations must be in place: The Department of Defense secretary issues a determination of military emergency or significant potential for military emergency The Department of Homeland Security secretary determines there's a domestic emergency or a significant potential for a domestic emergency. The Department of Health and Human Services secretary determines there's a public health emergency or a significant potential for a public health emergency. The DHS Secretary determines there's a material threat. After one of the above four determinations is in place, the HHS secretary can issue a declaration to justify issuing an EUA. The declaration is specific to EUAs and is not linked to other types of emergency declarations.