This week’s approval by the US Food and Drug Administration of Ebola is an important milestone in drug development – closely linked to our ongoing efforts to combat COVID-19.
Before COVID-19 began to spread worldwide, Ebola was one of the most widespread viral diseases on the planet. “Everyone was willing to speed up and contribute, as well as do what is not usually done with Ebola, because Ebola is in 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 so many that cause the same reactions and a variety of comprehensive approaches to things.”;
More than a year ago, experiments with Ebola finally paid off in more ways than one. The drug is an antibody treatment called Inmazeb, developed by Regeneron, and has dramatically helped increase the survival rate of Ebola patients during an outbreak in the Democratic Republic of the Congo (DRC). In addition to the drug capable of treating Ebola, the trials also provided a response plan for future viral outbreaks. At the time, researchers were testing ways to responsibly conduct clinical trials in the midst of fatal outbreaks. Some of the same methods that were tested during the Ebola epidemic are now being used to develop clinical trials for the treatment of COVID-19.
Ebola trials have focused on four possible treatments. Two of them, remdezivir and ZMapp, did not significantly reduce Ebola mortality – at least not compared to their competitors. The other two had much better results, increasing survival among some patients to 89-94 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 something. During the deadly Ebola outbreak in West Africa between 2013 and 2016, clinical trials moved too slowly and researchers were unable to obtain enough data to draw conclusions about possible treatments. Scientists knew that Ebola would return, and wanted to find a way to quickly test treatment for future outbreaks. The World Health Organization and many other international partners have learned lessons from the West African outbreak and devised a framework that could be used for ethical clinical trials in future outbreaks.
Researchers implemented the plan when the outbreak in the DRC began in 2018. They faced particularly difficult circumstances, including distrust of government and health officials, unstable energy supplies, and regional violence. But it still worked. “This test has shown that rigorous and ethically sound research can be conducted 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 test and the like is part of what helped the COVID-19 study begin so quickly after the virus began to spread. Back in February, researchers have already begun testing the treatment, modeling their efforts in the 2018 Ebola trials. “What we’ve learned from Ebola definitely helps us be even better during this outbreak.” Andre Kalil, a professor of internal medicine at the University of Nebraska Medical Center, spoke about this 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 emergency FDA approval in May, but is now back on thin ice). But even at extremely fast speeds, it still takes two years for Ebola treatment to move from clinical trials to full FDA approval. It may not take long to see the emergency approval of other COVID-19 procedures, 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.
Barrington’s strategy for a “herd immunity” strategy is a nightmare
This pandemic will last a long time. Many people would like to move on, and some have suggested rather unethical ways to do so. IN Vox, Brian Resnick reveals why the proposed “herd immunity” strategy is a nightmare – and seems like a rejection.
(Brian Resnick /Vox)
Rare complications of Covid-19 have been reported in children. Now it appears in adults.
A strange inflammatory syndrome appeared in some children with COVID-19 earlier this year. This condition is now found in several adults, but still seems rare.
(Erica Edwards /NBC)
“No one has clear answers to them”: Doctors are looking for treatments for long-term 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 has suspended testing of Eli Lilly Covid-19 antibodies due to safety concerns
Antibody testing was suspended this week due to safety concerns. Stat reports that the NIH suspended the trial because one of the two groups – either placebo or treatment – worked better than the other.
(Damian Garde and Matthew Herper /Become)
Johnson & Johnson discontinues trial of COVID-19 vaccine due to unknown disease
Another test for the vaccine was discontinued this week. The participant’s unexplained illness caused a pause. This is the second suspended trial of the COVID-19 vaccine. Two vaccine trials by Pfizer and Moderna are still ongoing in the United States. (Nicole Watsman /Facet)
Pfizer says it will not require vaccine registration until mid-November
For a while, Pfizer promised that the results of its vaccine trials would be available by mid-to-late October. Now they say that while they may have some data by the end of the month, they are not going to require FDA approval until at least November.
(Katie Thomas and Noah Wieland /NOW)
Remdesivir failed to prevent the death of Covid-19 during a huge trial
A WHO trial of remdezivir has shown that it does not prevent mortality. 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 states can mean 50 vaccine distribution strategies
Merin McKenna is leading us through the potentially dirty release of a future vaccine against COVID-19.
(Merin McKenna /Wired)
“Nearly 4,000 people work at Elmhurst Hospital, and about 3,000 of them are women.” Mattie Kahn highlights four women who helped support Elmhurst Hospital during the horrific COVID-19 jump in New York City earlier this year.
(Mattie Kahn / Glamor)
More than numbers
More than 39,393,994 people around the world who have passed positive tests, let your path to recovery be smooth.
The families and friends of the 1,105,462 people who died worldwide – 218,602 of those in the United States – do not forget about your loved ones.
Be safe, everyone.