FDA Announces Approval for Two COVID Therapeutic Oral Medications

Wednesday, the political FDA approved 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 {LINK}.

Yesterday, the political FDA approved Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing {LINK}.

The White House has been under considerable criticism for their lack of preparedness for the latest COVID variant called Omicron.  The FDA has rushed both oral medications under the Emergency Use Authorization (EUA) process.

FDA Announcement – […]    Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.

[…] Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorized for use for longer than five consecutive days.  (read more)

The White House has also been criticized for not having a program for mass distribution of testing kits in advance of their vaccine or test mandate.  However, we can reconcile the lack of planning for the testing program by accepting the premise that the Biden vaccine, or test mandate, was a pressure point intended to get people to take the vaccine, and they never originally intended enforcement.