Without a vaccine, there’s no assurance that the COVID-19 pandemic will end. A mix of legacy drugmakers and small startups have already stepped forward to develop vaccines or treatments that target the infection caused by the novel coronavirus. People vaccinated by these treatments can protect people against the infection as well as reduce transmission. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, said that finding a vaccine is an “urgent public health priority.”
However, Dale Fisher, chairman of the World Health Organization’s Global Outbreak Alert and Response Network, said that we most likely won’t see a vaccine until the end of 2021. This is because Phase 2 and 3 trials are necessary to guarantee both safety and efficacy and the need to ramp up production and distribution. Nonetheless, the vaccine race is anybody’s game. Johnson & Johnson, for instance, said that they are aiming to start human trials in September. The company is known for developing an Ebola vaccine.
Moderna, a biotechnology company, recently announced that it has released the first batch of mRNA-1273, the company’s vaccine against COVID-19. The vaccine encodes a prefusion stabilized form of the Spike (S) protein. According to PharmaNewsIntelligence, an online site that provides coverage of the pharmaceutical industry, the manufacturing of the vaccine was funded by the Coalition for Epidemic Preparedness Innovations (CEIPI). It will now be used in the planned Phase 1 study in the US.
“I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed. The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification,” Juan Andres, chief technical operations and quality officer at Moderna, said in the announcement.
But, of all treatments said to help us fight COVID-19, remdesivir is the most promising. Last week, Fauci said that remdesivir, an antiviral designed to combat Ebola, has a clear-cut, significant, positive effect in diminishing the time to recovery.
Remdesivir Shows Promise in COVID-19 Clinical Trial
Remdesivir, which was originally developed to treat Ebola and other deadly viruses, was created by the pharmaceutical giant Gilead Sciences. The company is best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease. It has also experience in creating and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP).
Preliminary data from the National Institutes of Health revealed that remdesivir is showing promise in treating adults with COVID-19. The antiviral drug speeds up recovery for some patients who were infected by the virus. The data showed that those who have received remdesivir recovered, on average, four days faster than patients who received a placebo (11 days versus 14 days). “Based on some of the data that has come out in the last couple of days, it seems that remdesivir does show some proven benefit over placebo,” Angela Branche, an assistant professor of in the department of medicine at the University of Rochester Medical Center’s Vaccine Treatment and Evaluation Unit, said.
The promising results of remdesivir weren’t supposed to be known immediately. However, a website leaked the results of Phase 3 clinical trials of the drug at the University of Chicago. According to the New York Times, an American newspaper based in New York City with worldwide influence and readership, most of the 113 patients with severe COVID-19 who were treated with daily infusions of remdesivir were discharged from the hospital in under a week, and only two died.
The results from the preliminary data also suggested a mortality rate of 8% for the group receiving remdesivir versus 11.6% for those in the placebo group. The drug trial involved over 1,000 hospitalized patients in the U.S., Germany, Denmark, Spain, Greece, and other countries. According to CBS News, an online site that covers breaking news, videos, and the latest top stories in world news, business, politics, health and pop culture, the drug works by stopping the replication mechanism of the coronavirus.
"Although a 31% improvement [in a lengthy recovery time] doesn't seem like a knockout 100%, it is a very important proof of concept," Fauci said, noting that "what it is proving is that a drug can block this virus."
Is Remdesivir the Solution to COVID-19?
Recently, the US Food and Drug Administration authorized remdesivir for emergency use to treat COVID-19. Many health experts have had high hopes for the drug, given the positive preliminary results. However, it’s still not clear how effective the drug is at fighting the virus. Dr. Andre Kalil, a principal investigator for the trial, said that he wants to see results that show "meaningful clinical benefits" for patients. "We want to see something that really matters, something that really changed the outcomes of these patients," he said.
While the results are indeed very promising, they are statistically insignificant. Fauci said more research will be needed. "That's important because it's lives saved, but it doesn't save 50%. Remdesivir isn't a game-changer, but it is a positive,” Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner with the US Food and Drug Administration, said.
According to Vox, a liberal-leaning American news and opinion website owned by Vox Media, the data behind the said results haven’t been revealed, let alone published in a peer-reviewed journal. Thus, trials involving this drug haven’t revealed a clear answer about its effectiveness. “It’s difficult to know what to make of that. It’s very unusual to say ‘We’ve found some good news but we can’t tell you what it is’,” John Norrie, a professor of medical statistics at the University of Edinburgh, said.
Experts also clarified that even if the drug does prove useful in the fight against this pandemic, it won’t eliminate the disease. Antivirals like remdesivir are most effective when taken early. While it could make a life-saving difference for some patients, it won’t save everyone. "It is very important to understand that remdesivir and antivirals, in general, are not silver bullets," Aneesh K. Mehta, an investigator at the remdesivir trial site at Emory University, said.
"They do not immediately get rid of an infection. They work by slowly preventing the virus from making more of itself,” Mehta added.