UCA

URGENT CARE ASSOCIATION

FDA Approves Emergency Use Authorization for New Pfizer Oral Therapy

On Wednesday, December 22, 2021 the FDA granted Emergency Use Authorization for PAXLOVID. The new drug is available for immediate distribution and approved partners can begin ordering the new drug on Thursday, December 23, 2021 through the Health Partner Ordering Portal (HPOP). There are only 65,000 doses currently available and those will likely go to state/territorial health departments. If your urgent care center is registered as a “Partner” or “Provider” through HPOP there is a chance that you may be able to order products directly starting Thursday. Distribution is expected to begin early next week.

Last week, UCA leaders met with the HHS therapeutics team to discuss recommendations for urgent care administration of this new therapeutic and most of our concerns were addressed regarding clinician prescribing and administration of the new drug.

 

Healthcare facilities or healthcare providers including urgent care centers are eligible for receiving, administering and prescribing PAXLOVID under the conditions consistent with the EUA. This list of approved prescribers includes: physicians, advanced practice registered nurses and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs.

 

There are limited quantities in the initial phase of distribution. The U.S. government has purchased an initial order of 10 million courses of PAXLOVID with expected delivery by the end of the 2022. However only 65,000 doses are currently available for distribution to state/territorial health departments. Approximately 200,000 doses will be available in January 2022 and Pfizer has already begun to ramp up production of the therapy to meet demands.


For more information please see the UCA FAQ.

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