21
January
2022
|
15:46 PM
America/Chicago

Information on EUA for Two Antiviral Drugs to Treat COVID Cases; Some PCR Tests may not Accurately Detect the Omicron Variant

Pharmacy is working directly with the TDSHS in obtaining both Paxlovid and Molnupiravir. Due to the limited stock, both medications are allocated by state and region. Pharmacy has completed all the forms and provided all the supporting documents to be completed  to be eligible to receive the medication but is waiting further communication from TDSHS as to when we will receive an allocation for our region of the state.

Pharmacy checks the state ordering portals daily and provides updates to the Command Center.

We want to provide you with some quick information, regarding the treatment of COVID-19.

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the use of two antiviral pills to treat COVID-19 cases: Molnupiravir ) from Merck) and Paxloid (from Pfizer).

Pharmacy is working directly with the TDSHS in obtaining both Paxlovid and Molnupiravir. Due to the limited stock both medications are allocated by state and region. Pharmacy has completed all the forms and provided all the supporting documents to be eligible to receive the medication but is waiting further communication from TDSHS as to when we will receive an allocation for our region of the state.

Pharmacy checks the state ordering portals daily and provides updates to the Command Center.

Paxloid

Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. 

Paxlovid is not authorized for the pre-exposure or post exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Click here to read the full FDA news release.

Click here to read an FAQ on the Emergency Use Authorization for Paxlovid for treatment of COVID-19.

Molnupiravir

The FDA also authorized Merck’s molnupiravir, to treat Covid-19 "for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate." Molnupiravir is not authorized for use in patients less than 18 years of age.

Click here to read a fact sheet for health care providers for the EUSA for molnupiravir.

FDA Issues List of PCR tests that may not accurately detect the omicron variant

The following tests are NOT being used by the medical center. This information is to keep you informed.

The FDA recently released a report that states that omicron has mutation that may cause some COVID-19 tests to miss the variant. The FDA states that the tests may not accurately detect the omicron variant and may provide a false negative result.

“The FDA's analysis to date has identified certain EUA-authorized molecular tests whose performance may be impacted by mutations in the SARS-CoV-2 omicron variant. These tests fall into two categories, as described below: those that are expected to fail to detect the SARS-CoV-2 omicron variant, and those that are expected to detect the SARS-CoV-2 omicron variant with a specific gene drop out detection pattern.” the report reads.

Tests expected to fail to detect the SARS-CoV-2 Omicron Variant (as of 12/27/2021)

Due to the inability of these tests to detect the SARS-CoV-2 omicron variant, the FDA recommends that these test should not be used until this issue of these tests’ inability to detect the omicron variant is resolved:

·       Meridian Bioscience, Inc. Revogene SARS-CoV-2

·       Applied DNA Science Linea COVID-19 Assay Kit

Issues Resolved: Tests Previously Expected to Fail to Detect the SARS-CoV-2 Omicron Variant

These tests have been modified or otherwise have addressed the issue of their inability to detect the omicron variant:

·       Tide Laboratories DTPM COVID-19 RT-PCR Test

Click here to read the full report.