Effective Against All Coronavirus Variants, The Prospect of a New Drug’s Availability in the US is Hindered by Regulatory Obstacles and Funding Shortages.
Over the past year, the United States has seen a decline in the effectiveness of Covid treatments as new variants of the virus continue to emerge. Currently, many patients are left with only one option, Paxlovid, which is highly effective but has dangerous interactions with other medications. However, a new class of variant-proof treatments may help to restock the country’s arsenal.
Clinical trial, nearly 2,000 patients were given a single injection of a so-called interferon drug, and the results showed a 50% decrease in the patient’s odds of being hospitalized, which rivals the results achieved by Paxlovid.
These interferon shots hold even more promise as they fortify the body’s own defense mechanisms against invading viruses, potentially helping to defend against not only Covid but also the flu and other viruses with the potential to cause future pandemics.
The commercialization of the drug, called pegylated interferon lambda, is uncertain. The Food and Drug Administration (FDA) told the drug’s manufacturer, Eiger Biopharmaceuticals, that it was not prepared to authorize it for emergency use. The reason for this is partly because the clinical trial did not include an American site, but only sites in Brazil and Canada, and was initiated and run by academic researchers rather than the company itself.
The FDA suggested that only a large clinical trial conducted in the United States and with more involvement from the company would suffice, a scenario that would require considerable funding and several years.
These barriers are causing concerns among experts who believe they may also be threatening the development of other next-generation Covid treatments and vaccines. Eiger executives stated that they might seek authorization for the interferon shot outside of the United States, such as in China, which has been looking for new treatment options. Despite the presence of vaccines and previous infections, Covid is still killing roughly 450 Americans daily, and many scientists are frustrated that they cannot already prescribe the shots.
Interferons are a group of proteins that alert neighboring cells to defend themselves after a virus invades. The coronavirus, like other viruses, is effective in reducing the body’s natural interferon response. A drug that delivers extra interferons could potentially help patients overcome the virus. By targeting the patient’s immune response rather than the virus itself, these treatments reduce the likelihood of the virus evolving to resist the drug.
While many monoclonal antibodies have fallen out of use due to their ineffectiveness against new variants, Paxlovid remains effective because it is difficult for the virus to get around. However, new variants could one day render it less useful. The use of interferons as a drug is not easy, as interferons can trigger wide-ranging side effects, including inflammation, which is a risk in Covid cases due to some patients having an overactive immune response.
Previous studies have tested interferon treatments only on patients who were already sick and in the hospital, meaning that the drugs were often administered too late, leading to mixed or disappointing results. However, a recent clinical trial tested the interferon treatment on patients early on in their infection, leading to more promising results.
In conclusion, pegylated interferon lambda offers great promise as a variant-proof treatment for Covid, but its commercialization is uncertain due to regulatory barriers. The drug fortifies the body’s defense mechanisms against invading viruses and reduces the likelihood of the virus evolving to resist the treatment.
Despite the challenges, the development of this and other next-generation Covid treatments and vaccines is crucial in addressing the ongoing toll from Covid and preparing for future pandemic.