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Still wanted: a treatment for the coronavirus


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In the early days of the coronavirus pandemic, there was hope that existing drugs may help cure people infected with the new virus.

But six months and a few false starts later, those hopes have been dashed. There have been just a handful of medicines approved or recommended since the World Health Organization (WHO) declared the coronavirus outbreak a pandemic in March, mostly to treat hospitalized people with severe Covid-19, the disease caused by the virus.

“We have very few tools now that have proven to be effective,” Mariangela Simao, WHO assistant director general for access to medicines, vaccines and pharmaceuticals, said this week.

She is hopeful, however, that some of the numerous ongoing large-scale tests of potential therapies will bring good news by the end of the year.

Researchers are in the process of conducting trials on almost 330 drugs, with some 150 of them already being tested on people, according to Policy Cures Research, a global health think tank. Out of those, almost 60 are in the late stages of testing.

The promise — and drawbacks — of biotherapies

Policy Cures Research CEO Nick Chapman told POLITICO that in the most optimistic scenario, a couple of so-called monoclonal antibodies, which could both prevent people from getting Covid-19 and treat the disease, could be approved by the end of the year.

The U.S. National Institutes of Health describes these antibodies as laboratory-made versions of proteins naturally produced by the immune system in response to invading viruses or other pathogens. “Monoclonal antibodies may provide short-term protection from SARS-CoV-2 and could serve as important components of the Covid-19 pandemic response until vaccines become available,” the NIH said.

Drugmakers Eli Lilly; Regeneron and Roche; and CSL Behring and Takeda are some of the companies working on such therapies, according to Chapman and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

There are some 70 of them under development for the treatment and prevention of Covid-19, according to the nonprofit scientific organization IAVI. They have already been used to treat different types of cancer and autoimmune disorders, with more than 100 licensed over the past 30 years, said a report released in August by IAVI and the global health foundation Wellcome.

These so-called biotherapies are the most promising class of drugs that really take on the virus, Chapman said. But they also have drawbacks.

Most of them are injectable, which poses challenges even in testing them — people don’t like to get shots, said Simao of the WHO.

Scaling up production to make millions of doses of the biotherapies will also be a big challenge, because there is limited capacity for that kind of manufacturing in the developing world, the WHO Chief Scientist Soumya Swaminathan said this week.

Finally, they are much more expensive than regular drugs, Chapman said, which could dramatically limit their potential impact.

Fulfilled and dashed hopes

“Most likely, there will not be a single effective treatment, there will not be the magic bullet to tackle and contain Covid-19,” the IFPMA director general Thomas Cueni told reporters in early September.

“We will need different treatments for different patient groups for different stages of disease,” he said.

Besides antibody therapies, the industry is also working on antivirals and drugs with anti-inflammatory effects to treat people with Covid-19, according to Cueni.

Gilead’s remdesivir, which received an emergency use authorization from the U.S. Food and Drug Administration in the spring and conditional marketing from the European Medicines Agency in the summer, is part of the antiviral category. A large study run by the NIH showed that it helps hospitalized people who are severely ill recover more quickly. Earlier this month, the FDA allowed it to also be used in other groups of hospitalized patients who are less ill. But it is not yet clear whether it prevents deaths.

Gilead CEO Daniel O’Day said the drug is still being tested in some 36 clinical trials. Among other things, they are looking to assess whether it works better at fighting the coronavirus in combination with other drugs — in a cocktail similar to the way medicines are combined to treat people with HIV, for example. The company is also testing whether the drug works when inhaled instead of injected, as is the case now, to make it easier to administer.

Remdesivir would not, however, work as a pill, because of the way it’s metabolized in the body, he said. Gilead has not been able to meet global demand for the drug so far, but it expects to be able to sometime in October, O’Day said.

Chapman, of Policy Cures Research, said it’s important to develop a pill form of treatment of coronavirus to ensure widespread use.

An experimental drug code-named EIDD-2801, which is being developed by Ridgeback Biotherapeutics and Merck & Co, could be that pill, he said. The drug inhibits the replication of multiple RNA viruses including SARS-CoV-2, Ridgeback said. In animal studies of coronaviruses that cause SARS and MERS, the drug has been shown to improve pulmonary function, decrease body-weight loss and reduce the amount of virus in the lung.

In early September, the WHO recommended the use of so-called corticosteroids to treat inflammation caused by coronavirus in people in severe or critical condition. Dexamethasone, which was found to be effective in people receiving breathing assistance, is one example. These cheap drugs have long been used to treat other conditions like asthma, allergies, lupus and rheumatoid arthritis.

Politicians have raised high hopes for treatments to fight the coronavirus, but some of the most-hyped therapies have also been the biggest busts. The most notorious: the drug hydroxychloroquine, which has been heavily promoted by U.S. President Donald Trump, among others.

The FDA gave hydroxychloroquine an emergency use authorization, only to retract it a few months later, after a clinical trial in hospitalized patients showed the drug had no benefit for decreasing the likelihood of death or speeding recovery. On the contrary, it could lead to serious health issues such as heart rhythm problems and blood disorders, the FDA warned.

In Japan, outgoing Prime Minister Shinzo Abe placed his bets on a drug sold under the brand name of Avigan to treat influenza. Testing of Avigan’s effects on coronavirus is expected to be complete this month in Japan, according to media reports, although an interim report in May was not promising.

Cueni, from global drug lobby IFPMA, said the industry has come a long way since the beginning of the pandemic, “but we have to honestly admit some hopes were dashed. Some hopes were fulfilled, and there’s more hope to come,” he said.

What is needed is a transformational therapy to fight the virus, Chapman from Policy Cures Research said. This is going to come later than some people may have hoped, he said.

The fixation on existing drugs as a potential virus cure, rather than on more promising medicines in earlier stages of development, “did set things back for sure,” he said.

COVID VACCINE RACE LATEST

AstraZeneca’s vaccine trial pause: Just as the U.S. was fretting about Trump rushing out a vaccine that had not been yet proven to be safe and effective, the testing for one of the most advanced candidate vaccines was paused due to safety concerns. A participant in the clinical trial has fallen ill, and a team is now investigating whether that was caused by the vaccine. AstraZeneca CEO Pascal Soriot said Thursday that the pause was not unusual in such trials. He did not confirm media reports that the participant has come down with transverse myelitis, an inflammatory illness that affects the spinal cord. If the company can resume the trial soon, it should know before the end of the year if the vaccine works to protect people against coronavirus infection, he said.

Vaccines need to prove more than efficacy to effectively fight the pandemic: Out of the eight front-running vaccine candidates, only one — produced by China’s CanSino — requires one dose for full immunization, Policy Cures Research says in a new analysis. And at least three of them — those being developed by Moderna; Pfizer/BioNTech; and AstraZeneca and Oxford University — do not meet the minimum product stability and storage criteria set by the WHO, according to the analysis. The think tank cautions that “for a broader public health impact, and to effectively mitigate the COVID-19 pandemic will require a vaccine which is appropriate in diverse contexts, including resource-limited settings and different age groups.”

Vaccine confidence before the pandemic: Mistrust and outright opposition to vaccination have long been an issue, and the current debate around a future coronavirus vaccine may make matters worse. A new report published on Thursday shows where the world was on trust in vaccines just before the virus took over.

Between November 2015 and December 2019, the “confidence in the importance, safety, and effectiveness of vaccines fell in Afghanistan, Indonesia, Pakistan, the Philippines, and South Korea,” says the report, led by Professor Heidi Larson from the Department of Infectious Disease Epidemiology at the London School of Hygiene & Tropical Medicine. She is also the founding director of the Vaccine Confidence Project. There were signs that confidence has improved between 2018 and 2019 in some European Union countries like Finland, France, Ireland, and Italy, “with recent losses detected in Poland.”

GLOBAL HEALTH SNAPSHOTS

North America: Excerpts from a Trump February interview with veteran journalist Bob Woodward have dominated the news cycle in the country because of the U.S. president’s admission that he was playing down the virus while knowing that it was more deadly than the flu. But some health journalists on Twitter have also picked up on something else Trump said and that the WHO has resisted to over the past few months: that the virus is airborne, and thus not only transmitted during contact between an infected person and a healthy one.

Latin America: Robot eases loneliness of Mexican coronavirus patients.

Asia: India reported a new record spike of some 95,000 cases of coronavirus infection in one day. The country has overtaken Brazil, becoming the second one in the world, after the U.S., in terms of number of cases — some 4.4 million as of September 10.

Europe: Teachers in a Bosnian village build an open-air classroom to protect children from Covid-19.

Middle East: Community transmission of coronavirus is widespread in war-torn Syria, the U.N. says.

Africa: Nigerian resident doctors suspended their strike to allow the government to deal with their demands for better pay and working conditions amid the pandemic.

Oceania: People in New Zealand are experiencing more depression and anxiety since the coronavirus lockdown, despite the country being seen as a success story in the global fight against the pandemic.

Global: Covid-19 could reverse decades of progress toward eliminating preventable child deaths, U.N. agencies warn.

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