This week’s approval of an Ebola drug from the US Food and Drug Administration is a major milestone in drug development – a closely linked to our current efforts to combat COVID-19.
Before COVID-19 began sweeping the world, Ebola was one of the most high-profile viral diseases on the planet. “Everyone was ready to accelerate and contribute and do things with Ebola that they do not routinely do because Ebola is such a serious situation,” said virologist Daniel Bausch The Verge’s Justine Calma in August last year. “There are many bad diseases in the world, but there are not many that evoke the same kind of reaction and kind of an approach to things from all hands on deck.”
More than a year later, and the Ebola experiments have finally paid off in more ways than one. The drug is an antibody treatment called Inmazeb developed by Regeneron and helped dramatically increase the survival rate of Ebola patients during an outbreak in the Democratic Republic of Congo (DRC). In addition to having a drug capable of treating Ebola, the trials also provided a plan to respond to future ‘outbreaks from all hands on deck’. Researchers at the time were piloting ways to responsibly conduct clinical trials amid deadly outbreaks. Now, some of the same techniques that were tested during the Ebola epidemic are being used to design clinical trials for COVID-19 treatments today.
The trial of Ebola drugs focused on four possible treatments. Two of them, remdesivir and ZMapp, did not dramatically reduce death rates in Ebola patients – at least not compared to their competitors. The other two had far better results, increasing the survival rate among some patients to between 89 and 94 percent. They 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, it was a new way of doing things. During the deadly Ebola outbreak in West Africa between 2013 and 2016, clinical trials moved too slowly and researchers could not get enough data to draw conclusions about potential treatments. The researchers knew that Ebola would return and wanted to find a way to quickly test treatments during future outbreaks of the disease. The World Health Organization and many other international partners took the lessons from the West African outbreak and came up with a framework that could be used to ethically conduct clinical trials during future outbreaks.
The researchers put the plan into action when an outbreak started in the DRC in 2018. They faced particularly challenging circumstances, including distrust of government and health officials, unstable power supply and regional violence. But it still worked. “This experiment showed 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 others like it is part of what helped COVID-19 research get underway so quickly after the virus began to spread. Back in February, researchers had already begun testing treatments and modeling their efforts from the Ebola trials in 2018. “What we learned from Ebola is certainly something that helps us get even better during this outbreak.” Andre Kalil, a professor of internal medicine at the University of Nebraska Medical Center, told 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 under certain circumstances and which may not. (Remdesivir received urgent FDA approval in May, but it 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 very long to see urgent approval of other COVID-19 treatments, but full approval can still be a distant spot on the horizon – even with all hands on deck.
Here’s what else happened this week.
The “herd immunity” strategy of the Great Barrington Declaration is a nightmare
This pandemic will continue for a long time. Many people would like to move on, and some have suggested some rather unethical ways to do so. On Vox, Brian Resnick breaks down why a proposed ‘herd immunity strategy’ is a nightmare – and looks a lot like giving up.
(Brian Resnick /Vox)
A rare Covid-19 complication was reported in children. Now it appears in adults.
A strange inflammatory syndrome occurred in some children with COVID-19 earlier in the year. The condition now appears in a few adults, but it still looks rare.
(Erika Edwards /NBC)
‘Nobody has very clear answers to them’: Doctors are looking for treatments for covid-19 stretchers
Researchers and doctors are still trying to figure out how to care for COVID-19 patients with symptoms that just do not go away.
(Lenny Bernstein /Washington Post)
NIH pauses Eli Lilly Covid-19 antibody trial due to security concerns
An antibody treatment trial was put on hold this week due to safety concerns. State reports that the NIH stopped the trial because one of the two groups – either placebo or the treatment – did better than the other.
(Damian Garde and Matthew Herper /State)
Johnson & Johnson stops COVID-19 vaccine trials due to unexplained illness
Another trial, this one for a vaccine, was halted this week. An unexplained illness in one participant caused the trial to stop. This is the second COVID-19 vaccine trial to be put on hold. Two vaccine trials run by Pfizer and Moderna are still ongoing in the United States. (Nicole Wetsman /Edges)
Pfizer says it will not apply for a vaccination permit by mid-November
For a while, Pfizer promised it would have results from its vaccine trials in mid to late October. Now they say that even though they may have some data before the end of the month, they will not seek FDA approval until November at the earliest.
(Katie Thomas and Noah Wieland /NOW)
Remdesivir avoids preventing Covid-19 deaths in huge lawsuits
A WHO trial of remdesivir showed that it did not prevent death. The analysis has not yet been peer-reviewed, and some researchers say the experiment was not designed correctly. (Katherine J Wu /NOW)
In the United States, 50 states could mean 50 vaccine rollout strategies
Maryn McKenna takes us through the potentially messy rollout of a future COVID-19 vaccine.
(Maryn McKenna /The 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 keep Elmhurst Hospital running under New York City’s horrific COVID-19 tip earlier this year.
(Mattie Kahn / Glamor)
More than numbers
For the more than 39,393,994 people around the world who have tested positive, your path to recovery can be smooth.
To the families and friends of the 1,105,462 people who have died worldwide – 218,602 of them in the United States – your loved ones will not be forgotten.
Rest assured, everyone.