The U.S. has confirmed its first cases of the new omicron COVID-19 variant.
Health officials say the confirmed case is in California from a traveler who recently returned from South Africa. On Thursday, the Minnesota Department of Health announced that someone tested positive for the omicron variant in their state.
Here in Michigan, the state has reported more than 16,000 new COVID cases over the last few days -- an average of 8,200 new cases per day on Monday and Tuesday.
An anti-COVID pill made by drugmaker Merck has been under review by officials, and on Wednesday its fate rested in the hands of the Food and Drug Administration (FDA).
On Tuesday, a panel of outside experts narrowly recommended that the COVID pill be granted emergency use authorization, by a vote of 13 to ten. The vote was particularly close because panelists are weighing the risks versus the rewards of the medication.
Read more: US panel backs first-of-a-kind COVID-19 pill from Merck
Merck’s most recent data found that the antiviral medication molnupiravir reduced the risk of hospitalization or death by 30%. But despite that metric, panelists were concerned about the risk of side effects, as well as the drug’s potential to actually increase circulating mutations of the virus.
Molnupiravir is an antiviral drug that can be given orally. The dose would be 800 milligrams twice a day for five days. This drug is only for use after a person is infected with COVID-19 -- it does not prevent infection.
The drug works by mimicking one of the pieces needed to build the virus’ genetic code. The mimic, called NHC< gets added when the virus tries to replicate.
“The incorporation of NHC results in errors of the CoV-2 RNA,” said Dr. Daria J. Hazuda. “The accumulation of errors impacts the ability of Sars-Co-V-2 to replicate in cell culture models, animals models, and in infected patients.”
Such errors break the cycle of spread.
“The drug induces a large number of viral errors in the Sars-CoV-2 genome, ultimately leading to a virus incapable of further replication,” said Nicholas Kartsonis, MD.
While the errors stop replication, this process has some potential downsides. Officials say that, based on animal models, there is some concern about harm to a developing fetus.
“These findings still need to be considered when administering molnupiravir to women of childbearing potential, and we are not recommending use during pregnancy,” said Dr. Kerry Blanchard.
Related: Michigan hospital data: 87% of COVID ICU patients are unvaccinated
Other animal research suggests that the drug may have an effect on developing bones. According to Blanchard, scientists observed “effects on the growth plates of rats” who had received the medication, triggering concern over what may happen if children took the pill.
There was also extensive discussion on the potential for this drug to raise the risk of cancer, as well as questions about whether the medication could increase the risk of producing more variants of the virus, particularly in those with compromised immune systems.
The advisory panel thought these issues all require more study. So what happens next with the drug?
The FDA will decide how to move forward. The administration is not required to follow the recommendation of its advisors, but it usually does.
Several of the experts voiced the opinion that there is a need for a drug like Merck’s for those who are high risk and can’t get monoclonal antibodies -- which are more effective, but also more difficult to administer.
More: Coronavirus coverage