This week’s US Food and Drug approval of 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 began to ravage the world, Ebola was one of the most popular viral diseases on the planet. “Everyone is ready to speed up and contribute and do things with Ebola that they do not do regularly because Ebola is a very difficult situation,” said virologist Daniel Bausch The Verge’s Justine Calma in August. “There are many bad diseases in the world, but there are not many that provoke the same kind of response and kind of an approach at all.”;
More than a year has passed, and Ebola experiments have finally paid off in more ways than one. The drug is an antibody treatment called Inmazeb developed by Regeneron, and has greatly helped to increase survival rates in Ebola patients during the outbreak of the Democratic Republic of the Congo (DRC). In addition to having the drug capable of treating Ebola, the tests also provided a plan for responding to future ‘all-hands-on-deck’ viral outbreaks. Researchers at the time pioneered ways to responsibly conduct clinical trials in the midst of a deadly outbreak. Today, 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 trial for Ebola drugs focuses on four possible treatments. Two of them, remdesivir and ZMapp, did not significantly reduce mortality rates in Ebola patients – at least compared to their competitors. The other two have better outcomes that increase survival rates among some patients between 89 and 94 percent. They both use lab-grown labs known as monoclonal antibodies to help cure people infected with the virus. One of the successful drugs, REGN-EB3, later became Inmazeb.
At that time, it was a new way of doing things. During the deadly Ebola outbreak in West Africa between 2013 and 2016, clinical trials were too slow, and researchers were not getting enough data to come to conclusions about potential treatments. Scientists know that Ebola will return, and want to find a way to quickly test treatments during the future outbreak. The World Health Organization and many other international partners have taken lessons from the West Africa outbreak and have developed a framework that can be used to conduct ethical clinical trials on future outbreaks.
Researchers carried out the plan when a DRC outbreak began in 2018. They faced specific challenges, including mistrust of government and health officials, unstable power supplies, and violence in region. But it still works. “This test has shown that it is possible to conduct scientific rigorous and ethical 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, was part of what helped COVID-19 research that took place quickly after the virus started to spread. Back in February, researchers began testing treatments, modeling their efforts on Ebola trials in 2018. “What we learned from Ebola is definitely something that helps us to be better with the weather. of this outbreak. ” Said Andre Kalil, a professor of internal medicine at the University of Nebraska Medical Center The Verge’s Nicole Wetsman in February.
There is still a long way to go. We are beginning to see early signs of what drugs might work to treat COVID-19 under certain circumstances, and which ones do not. (Remdesivir received emergency approval in May but is on ice again). But even at very fast speeds, it still took two years for Ebola treatment to go from clinical trials to full FDA approval. It may not take long to see the emergency approval of another COVID-19 treatment, but full approval can still be a distant particle on the horizon – even if all hands are on deck.
Here’s what else happened this week.
The Great Barrington Declaration’s “flock of immunity” approach is a nightmare
This pandemic is set to continue for a long time. Many people want to keep going, and some have suggested some relatively unethical ways to do this. Sa Vox, Brian Resnick breaks down why a proposed ‘flock of immunity’ approach is a nightmare – and it looks like giving.
(Brian Resnick /Vox)
A rare complication of Covid-19 has been reported in children. Now, it shows up in adults.
A strange inflammatory syndrome appeared in some children with COVID-19 earlier this year. The condition is now showing up in some adults, but it still seems to be rare.
(Erika Edwards /NBC)
‘No one has clear answers for them’: Doctors looking for treatment for covid-19 long-haulers
Researchers and doctors are still trying to figure out how to treat COVID-19 patients with symptoms that do not go away.
(Lenny Bernstein /Washington Post)
The NIH will suspend Eli Lilly Covid-19 antibody trial due to safety concerns
An antibody treatment trial was paused this week amid safety concerns. Stat It was reported that the NIH paused the trial because one of the two groups – either placebo or treatment – was better than the others.
(Damian Garde and Matthew Herper /Stat)
Johnson and Johnson will pause the COVID-19 vaccine test for an unexplained illness
Another test, this one for a vaccine, was stopped this week. An unexplained illness in one participant caused the test to be stopped. This is the second COVID-19 vaccine test postponed. Two vaccine trials, administered by Pfizer and Moderna, are still ongoing in the US. (Nicole Wetsman /The Verge)
Pfizer Says It Will Not Seek Vaccine Permit Before Mid-November
Moments later, Pfizer promised it would have results from vaccine tests from mid to late October. Now, they say that even if they have some data at the end of the month, they will not ask for FDA approval before November at the earliest.
(Katie Thomas and Noe Wieland /NOW)
Remdesivir Failed to Prevent Covid-19 Deaths in Massive Trial
A WHO trial on remdesivir found that it did not prevent death. The review has not been reviewed by both, and some researchers say the test is not well-designed. (Katherine J Wu /NOW)
In the US, 50 States Can Mean 50 Vaccine Rollout Strategies
Maryn McKenna will take us to the potentially chaotic launch of a COVID-19 vaccine in the future.
(Maryn McKenna /Wired)
The Guardians of Elmhurst
“About 4,000 people work at Elmhurst Hospital, and almost 3,000 of them are women.” Mattie Kahn highlights four of the women who helped keep Elmhurst Hospital running during New York City’s frightening COVID-19 spike this year.
(Mattie Kahn / Glamor)
More than numbers
Of the more than 39,393,994 people worldwide who tested positive, may your road to recovery be smooth.
To the families and friends of 1,105,462 people who died worldwide – 218,602 of those in the US – your loved ones will never be forgotten.
Stay safe, everyone.