PHILADELPHIA (KYW Newsradio) — The FDA is planning to discuss the first of two antiviral pills to fight COVID-19 on Tuesday. New Jersey-based Merck & Co.'s anti-viral COVID-19 pill is called Molnupiravir.
"They named it after Thor's hammer," said Dr. Richard Lorraine, medical director of the Montgomery County Office of Public Health. Thor's hammer in Norse mythology is Mjölnir.
"I just I love the image of that, because, you know, I think this is a pharmaceutical equivalent of Thor's hammer."
The FDA’s Antimicrobial Drugs Advisory Committee will discuss the drug. Draft questions currently on the FDA website indicate the discussion will focus on using the drug during pregnancy and the possibility of viral mutations and what limits should be considered.
Lorraine says the layers of prevention, including vaccines and other mitigation efforts, and better and more accessible treatments, are all steps needed to move from pandemic to endemic.
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"The more important goal is decreasing the severity of cases, decreasing the hospitalizations and decreasing the deaths. And this is where this medication, the one that's coming from Pfizer, perhaps other ones that are in development — that's going to make that difference."
The pills could be game changers, as they’re much easier to give than other treatments currently available.
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However, Lorraine says, like any drug, it comes down to a risk-benefit assessment, which briefing materials say supports an emergency authorization.
Lorraine says the committee will have to decide if a positive test is required for the drug to be prescribed.
"Because, whatever the risk is, it now outweighs potential benefit. That's why it's really important to confirm that … a potential patient has actual COVID infection before prescribing this," he said.
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Dr. Angie Nicholas, Einstein Medical Center Montgomery's chief medical officer, says there will have to be a balance between getting to people quickly enough for it to be effective, and making sure those people actually need it.
"We want to make sure that we're giving it to the people that actually have COVID to prevent … the replication of the virus and prevent that patient from ending up in the hospital or developing severe symptoms."
The pills would lessen the severity of COVID-19 symptoms if given early enough. Initial estimates said the pills could prevent about 50% of hospitalizations and death if given within a few days of symptom onset. Late last week, Merck adjusted that figure to 30%.
Pfizer says its COVID-19 antiviral pill — which will be similarly vetted by the FDA — is 89% effective.