This week’s approval by the US Food and Drug Administration for an Ebola drug is a major milestone in drug development – one that is closely linked to our current efforts to combat COVID-19.
Before COVID-19 spread worldwide, Ebola was one of the most famous viral diseases on the planet. “Everyone was willing to speed up and contribute and do things with Ebola that they don’t do routinely because Ebola is such a terrible situation,” said virologist Daniel Bausch. The Verge’s Justin Calma last August. “There are many bad diseases in the world, but not many that provoke the same kind of reaction and some kind of deck approach to things.”
More than a year later, Ebola experiments have finally paid off in more ways than one. The drug is an antibody treatment called Inmazeb, developed by Regeneron, and has dramatically helped increase survival rates in Ebola patients during an outbreak in the Democratic Republic of the Congo (DRC). In addition to the drug that can cure Ebola, studies have also provided a plan for responding to future viral outbreaks of “all hands on deck.” At the time, researchers were piloting ways to responsibly conduct clinical trials in the midst of deadly outbreaks. Now, some of the same techniques that were piloted during the Ebola epidemic are being used to design clinical trials for the treatment of COVID-19 today.
The Ebola drug trial focuses on four possible treatments. Two of them, remdezivir and ZMapp, did not drastically reduce mortality in Ebola patients – at least not compared to their competitors. The other two performed significantly better, increasing survival rates among some patients to between 89 and 94 percent. Both used laboratory-grown antibodies known as monoclonal antibodies to help cure people infected with the virus. One of the successful drugs, REGN-EB3, later became Inmazeb.
At the time, this was a new way of doing things. During the deadly Ebola epidemic in West Africa between 2013 and 2016, clinical trials were moving too slowly and researchers were unable to obtain enough data to draw conclusions about potential treatments. The scientists knew that Ebola would return, and they wanted to find a way to quickly test the treatment during future outbreaks. The World Health Organization and many other international partners have learned the lessons from the West African outbreak and come up with a framework that can be used to ethically conduct clinical trials during future outbreaks.
Researchers put the plan into action when the outbreak in the DRC began in 2018. They face particularly difficult circumstances, including distrust of government and health officials, unstable power supplies and regional violence. But it still worked. “This test has shown that it is possible to conduct scientifically rigorous and ethically sound research during an outbreak, even in a conflict zone,” the researchers wrote in a report published in New England Journal of Medicine in 2019.
The success of the 2018 Ebola trial and the like is part of what helped COVID-19 research begin so quickly after the virus began to spread. As early as February, researchers had already begun testing treatments, modeling their efforts from Ebola trials in 2018. “What we learned from Ebola is definitely something that helps us be even better during this outbreak.” Andre Kalil, a professor of internal medicine at the University of Nebraska Medical Center, said The Verge’s Nicole Wetsman in February.
There is still a long way to go. We are beginning to see early signs of which drugs may work to treat COVID-19 in certain circumstances and which may not. (Remdesivir received urgent FDA approval in May, but is now on thin ice again). But even at remarkably fast speeds, it still took two years for Ebola treatment to go from clinical trials to full FDA approval. It probably won’t take long to see urgent approval of other COVID-19 treatments, but full approval may still be a distant speck on the horizon – even with all hands on deck.
Here is what happened this week.
Barrington’s Grand Declaration’s strategy for “herd immunity” is a nightmare
This pandemic will last a long time. Many people would like to move forward, and some have suggested quite unethical ways to do so. IN Vox, Brian Resnick explains why the proposed “herd immunity” strategy is a nightmare – and it’s a lot like giving up.
(Brian Resnick /Vox)
A rare complication of Covid-19 has been reported in children. It now appears in adults.
A strange inflammatory syndrome appeared in some children with COVID-19 earlier this year. The condition now occurs in several adults, but still seems rare.
(Erica Edwards /NBC)
“No one has very clear answers about them”: Doctors seek treatment for long carriers covid-19
Researchers and doctors are still trying to figure out how to care for COVID-19 patients with symptoms that simply won’t go away.
(Lenny Bernstein /Washington Post)
The NIH paused the Eli Lilly Covid-19 antibody study for safety reasons
An antibody treatment study was suspended this week due to safety concerns. statistics reported that the NIH discontinued the study because one of the two groups – either placebo or treatment – performed better than the other.
(Damian Garde and Matthew Herper /Statistics)
Johnson & Johnson is pausing the vaccine against COVID-19 due to an unexplained illness
Another trial, a vaccine, was stopped this week. An unexplained illness of a participant led to a pause in the process. This is the second trial of a vaccine against COVID-19 that has been stopped. Two vaccine trials conducted by Pfizer and Moderna are still ongoing in the United States. (Nicole Wetsman /On the edge)
Pfizer says it will not seek permission for the vaccine until mid-November
For a while, Pfizer promised that it would have the results of its vaccination trials by mid-to-late October. Now they say that although they have some data by the end of the month, they will not seek FDA approval until November at the earliest.
(Katie Thomas and Noah Wieland /NOW)
Remdezivir fails to prevent the death of Covid-19 in a huge process
A WHO study of remdezivir found that it did not prevent deaths. The analysis has not yet been reviewed, and some researchers say the test was not designed properly. (Catherine J. Wu /NOW)
In the United States, 50 countries can mean 50 vaccine distribution strategies
Merin McKenna takes us through the potentially messy introduction of a future vaccine against COVID-19.
(Merin McKenna /Cable)
The Guardians of Elmhurst
“Nearly 4,000 people work at Elmhurst Hospital and about 3,000 of them are women.” Mattie Kahn highlights four of the women who helped maintain Elmhurst Hospital during the horrific COVID-19 jump in New York earlier this year.
(Mati Kan / Shine)
More than numbers
For more than 39,393,994 people around the world who have been positive, let your path to recovery be smooth.
For the families and friends of the 1,105,462 people who died worldwide – 218,602 of those in the United States – your loved ones are not forgotten.
Be safe, everyone.