info@businessghana.com
With COVID-19 cases worldwide hitting the 2 million mark and continuing to grow, scientists are pushing forward with efforts to develop vaccines and treatments to slow the pandemic and lessen its damage.
Some of the earliest treatments will likely be drugs that are already approved for other conditions or have been tested on other viruses.
“People are looking into whether existing antivirals might work or whether new drugs could be developed to try to tackle the virus,” said Dr. Bruce Y. Lee, a professor at the City University of New York Graduate School of Public Health & Health Policy.
HEALTHLINE’S CORONAVIRUS COVERAGE
Stay informed with our live updates about the current COVID-19 outbreak. Also, visit our coronavirus hub for more information on how to prepare, advice on prevention and treatment, and expert recommendations.
The antiviral drugs were a topic of a March 18 White House briefing on the COVID-19 outbreak.
President Trump said he was pushing the Food and Drug Administration (FDA) to eliminate barriers to get treatments to people with coronavirus.
A few days later, the FDA issued an emergency use declaration for the anti-malaria drugs hydroxychloroquine and chloroquine.
About 30 million doses of hydroxychloroquine and 1 million doses of chloroquine were donated to the nation’s Strategic National Stockpile.
The medications can be distributed and prescribed by doctors for adults and teens hospitalized with the COVID-19 illness when a clinical trial isn’t available.
However, the following week officials from the European Union said there is no evidence that hydroxychloroquine was effective in treating COVID-19.
The use of these medications was also questioned in an opinion piece Trusted Sourcein the journal Annals of Internal Medicine.
The authors raised questions about recent studies done on the anti-malaria drugs and whether there has been a “rush to judgement” on getting them through the approval pipeline.
Indeed, don’t expect these two drugs to be available at your pharmacy any time soon.
FDA officials have stated it could still be a year before any drugs are available to the general public for coronavirus treatment because the agency needs to make sure the medications are safe for this particular use and what the proper dosage should be.
Indeed, there’s only so much that vaccine and drug development can be sped up, even with improvements in genetic sequencing and other technologies.
“Even though technological advances allow us to do certain things more quickly,” Lee told Healthline, “we still have to rely on social distancing, contact tracing, self-isolation, and other measures.”
Here’s a rundown of the latest COVID-19 vaccine and drug developments.
CORONAVIRUS UPDATES
Get updates on COVID-19, plus support for managing your health
Discover ways to take care of your physical and mental health while staying on top of the latest news and updates.
Your privacy is important to us
Treatment
Several companies are developing or testing antivirals against the virus that causes COVID-19.
Antivirals target the virus in people who already have an infection. They work in different ways, sometimes preventing the virus from replicating, other times blocking it from infecting cells.
Lee says antivirals work better if you administer them sooner, “before the virus has a chance to multiply significantly.”
And also before the virus has caused significant damage to the body, such as to the lungs or other tissues.
Dr. Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and a former chief medical officer at the Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR), says both antivirals and vaccines will be valuable tools in combating COVID-19.
However, he told Healthline that “antivirals are likely to be developed and approved before a vaccine, which typically takes longer.”
Drug development is sometimes described as a pipeline with compounds moving from early laboratory development to laboratory and animal testing to clinical trials in people.
It can take a decade or more for a new compound to go from initial discovery to the marketplace. Many compounds never even make it that far.
That’s why antivirals being eyed as treatments for COVID-19 are drugs that already exist. They include:
Remdesivir. Developed a decade ago, this drug failed in clinical trials against Ebola in 2014. But it was found to be generally safe in people. Research with MERS showed that the drug blocked the virus from replicating. It’s now being tested in five COVID-19 clinical trialsTrusted Source. The first results should be available in April.
Kaletra. This is a combination of two drugs that work against HIV. Clinical trials are planned to see whether it works against the virus that causes COVID-19.
Chloroquine. Initial laboratory studiesTrusted Source show that this antimalarial drug may work against the COVID-19 virus by blocking infection. A small clinical trial of this drug in France suggests it may work as a treatment for COVID-19. However, the study wasn’t randomized, so larger clinical trials will be needed. Researchers at the University of Queensland in Australia expect to start a clinical trial of chloroquine and an HIV drug soon. The drug, along with hydroxychloroquine, were granted emergency use designation by the FDA on March 29. In a study published in mid-April, French researchers said it appears hydroxychloroquine didn’t help people hospitalized with COVID-19. They added there were also side effects involving heart health complications.
Favipiravir. This drug is approved in some countries outside the United States to treat influenza. Some reports from China suggest it may work as a treatment for COVID-19. These results, though, have not been published yet.
Scientists are also looking at other ways to target the virus or treat the complications of COVID-19, such as:
Monoclonal antibodies. These drugs trigger the immune system to attack the virus. Vir Biotechnology has isolated antibodies from patients who survived SARS. The company is working with Chinese firm WuXi Biologics to test them as a treatment for COVID-19. AbCellera has isolated 500 unique antibodies from a person who recovered from COVID-19 and is set to start testing them.
Blood plasma transfers. Along the same lines, the FDA has announcedTrusted Source a process for medical facilities to conduct trials on an experiment treatment that uses blood plasma from people who have recovered from COVID-19. The theory is that the plasma contains antibodies that will attack this particular coronavirus. On Friday, the New York Blood Center began collecting plasma from people who have recovered from COVID-19.
Stem cells. Athersys Inc. released preliminary data last year showing that its stem cell treatment could potentially benefit people with acute respiratory distress syndrome (ARDS). This condition occurs in some people with severe COVID-19. MesoblastTrusted Source tested its stem cell product in a small group of people with COVID-19 with positive results.
Immune suppressants. In some people with COVID-19, the immune system goes into overdrive, releasing large amounts of small proteins called cytokines. Scientists think this “cytokine storm” may be the reason certain people develop acute respiratory disease syndrome (ARDS) and need to be put on a ventilator. Several immune suppressants are being tested in clinical trials to see if the drugs can quell the cytokine storm and reduce the severity of ARDS. These include baricitinib, a drug for rheumatoid arthritis as well as CM4620-IE, a drug for pancreatic cancer, and IL-6 inhibitors. The FDA has also approved a device that filters cytokines out of the blood of patients.
While a lot of the focus is on developing new treatments for COVID-19, improvements in how doctors care for patients using existing technology are also crucial.
“The things that we have to worry about with the novel coronavirus is that it can cause pneumonia and acute respiratory distress syndrome,” Lee said. “There are ways of treating those things that can reduce the effects, so doctors are trying to use those as well.”
No company has offered a timeline for when its drug might be used more widely to treat COVID-19. This isn’t an easy thing to estimate.
After laboratory and animal testing, drugs have to pass through several clinical trial stagesTrusted Source before they can be approved for widespread use in people.
It’s also difficult to speed things up, because scientists have to enroll enough people in each stage to have useful results. They also have to wait long enough to see whether there are harmful side effects of the drug.
However, drugs can sometimes be given to people outside a clinical trial through the Food and Drug Administration’s “compassionate useTrusted Source” program. For this to happen, people must have an “immediately life-threatening condition or serious disease or condition.”
Doctors at the University of California, Davis were able to secure this type of approval for a woman with severe COVID-19 to receive remdesivir. They report that she’s now doing well.
Many will take this as a sign that the drug works. But because the drug was given outside of a clinical trial to just one person, it’s not possible to know for certain. Also, other people may not have the same response to the drug.
Clinical trial stages
Phase I. The drug is given to a small number of healthy people and people with a disease to look for side effects and figure out the best dose.
Phase II. The drug is given to several hundred people who have the disease, looking to see whether it works and if there are any side effects that weren’t caught during the initial testing.
Phase III. In this large-scale trial, the drug is given to several hundred or even up to 3,000 people. A similar group of people take a placebo, or inactive compound. The trial is usually randomized and can take 1 to 4 years. This stage provides the best evidence of how the drug works and the most common side effects.
Phase IV. Drugs that are approved for use undergo continued monitoring to make sure there are no other side effects, especially serious or long-term ones.
Vaccine
A vaccine is designed to protect people before they’re exposed to a virus — in this case, SARS-CoV-2, the virus that causes COVID-19.
A vaccine basically trains the immune systemTrusted Source to recognize and attack the virus when it encounters it.
Vaccines protect both the person who’s vaccinated and the community. People who are vaccinated can’t become infected with a virus, which means they can’t pass it to others. This is known as herd immunity.
Many groupsTrusted Source are working on potential vaccines for SARS-CoV-2, with several backed by the nonprofit Coalition for Epidemic Preparedness Innovations (CEPI).
Several of these groups started their work shortly after Chinese scientists shared the genetic sequence of the virus. These include:
Moderna. This week, the company began testing its messenger RNA (mRNA) vaccine in a phase I clinical trial in Seattle, Washington. The study includes 45 healthy volunteers, ages 18 to 55. The company has developed other mRNA vaccines before. Those earlier studies showed that their platform is safe, which allowed the company to skip certain animal testing for this specific vaccine.
Inovio. When COVID-19 appeared in December, the company had already been working on a DNA vaccine for MERS, which is caused by another coronavirus. This allowed the company to quickly develop a potential vaccine for the COVID-19 virus. The company is expected to start clinical trials for its new vaccine next month.
University of Queensland in Australia. Researchers are developing a vaccine by growing viral proteins in cell cultures. They expect to start clinical trials later this month.
Pharmaceutical companies. Johnson & Johnson and Sanofi are both working on a vaccine of their own.
Advances in genetic sequencing and other technological developments have sped up some of the earlier laboratory work for vaccine development.
However, Dr. Anthony FauciTrusted Source, director of the National Institute of Allergy and Infectious Diseases, told reporters last week that a vaccine won’t be available for widespread use for at least another 12 to 18 months.
This is the timeline to complete the phase III clinical studies.
Meanwhile, some clinical trials are under way in the Netherlands and Australia to see if existing vaccines for tuberculosis might also protect against the COVID-19 virus.
The polio vaccine is another possible option. Scientists think these vaccines might boost the immune system just enough to fight off the coronavirus, although there is no evidence yet to confirm this theory.
There’s no guarantee any of the vaccine candidates will work.
“There’s a lot of uncertainty with vaccine development,” Lee said. “Naturally, you have to make sure the vaccine is safe. But you also have to make sure the vaccine will elicit enough of an immune response.”
Like drugs, potential vaccines have to pass through the same clinical trial stagesTrusted Source. This is especially important when it comes to safety, even during a pandemic.
“The public’s willingness to back quarantines and other public-health measures to slow spread tends to correlate with how much people trust the government’s health advice,” Shibo Jiang, a virologist at Fudan University in China, wrote in the journal NatureTrusted Source.
“A rush into potentially risky vaccines and therapies will betray that trust and discourage work to develop better assessments,” he said.
