What to Know
- As the novel coronavirus, known as COVID-19, spreads around the country and the globe, sickening more than 100,000 people and killing about 3,000 worldwide, many are wondering: how close are we to a cure?
- The short answer: possibly more than a year away since a vaccine cannot be developed overnight given that the process is intensive, time-consuming and regulated
- Testing a vaccine has to proceed in stages -- not only to make sure that it indeed works but to make sure it is safe to use on people
As the novel coronavirus disease, known as COVID-19, spreads around the country and the globe, killing over 5,000 worldwide and sickening more than 150,000, many are left wondering: how close are we to a cure?
THE SHORT ANSWER: We are possibly more than a year away since a vaccine cannot be developed overnight given that the process is intensive, time-consuming and regulated.
LATEST NEWS: On Tuesday, March 24, the state of New York will start conducting trials of an experimental COVID-19 treatment with the malaria drug hydroxychloroquine and the antibiotic Zithromax, Gov. Andrew Cuomo said.
A clinical trial evaluating a vaccine designed to protect against the new coronavirus also began last week, March 16.
A government official says the first participant in the trial will receive the experimental vaccine that day. The National Institutes of Health is funding the trial that is taking place at a Kaiser Permanente research facility in Seattle. Testing will begin with 45 young, healthy volunteers with different doses of shots co-developed by NIH and Moderna Inc. Public health officials say it will take a year to 18 months to fully validate any potential vaccine.
On March 30, Johnson & Johnson announced it selected a lead vaccine candidate and says it expects to begin Phase 1 human clinical trials by September at the latest.
"We're very excited about the announcement that we're making this morning about the partnership we're doing with Barta, the government agency responsible for pandemics and vaccines and what we're doing to accelerate our development but also our production for something against COVID-19," Johnson & Johnson CEO Alex Gorsky said during an interview.
"We expect to have results, interim results from our trials likely in December at the latest early January. That should put us in position early in 2021 to have hundreds of millions of doses available and by the end of the year up to 1 billion. That's our plan," Gorsky went on to say.
THE LONG ANSWER: Testing a vaccine has to proceed in stages -- not only to make sure that it indeed works but to make sure it is safe to use on people. This is a process that can take months, if not over a year, according to Dr. Anthony Fauci of the National Institutes of Health.
While there is currently no vaccine to prevent coronavirus disease 2019, the World Health Organization said on March 6 that it has received applications for 20 vaccines in development and many clinical trials of therapeutics are underway.
Earlier in the week, President Donald Trump met with pharmaceutical companies to talk about progress toward a vaccine.
Trump and members of his Cabinet met at the White House with executives of 10 pharmaceutical companies to discuss ways to speed the development of a vaccine for the coronavirus.
There are no proven treatments for COVID-19. In China, scientists have been testing a combination of HIV drugs against the new virus, as well as an experimental drug named remdesivir that was in development to fight Ebola. In the U.S., the University of Nebraska Medical Center also began testing remdesivir in some Americans who were found to have COVID-19 after being evacuated from a cruise ship in Japan.
It's not clear how quickly such studies will answer whether any of the drugs help. Many patients recover without needing any treatment. The biggest concern is how to help the fraction who become severely ill.
Testifying before the Senate on Tuesday, Fauci made it clear that neither a coronavirus treatment nor a vaccine can be ready quickly. Fauci indicated potential treatments may come before a vaccine.
Based on data from China, Fauci said about 80% of people who get infected "do really quite well" and recover without any medical treatment. But about 10% to 15% get seriously ill, particularly those in high-risk groups such as the elderly or patients with other medical problems.
While a treatment may be identified in a matter of months, Fauci said a vaccine would take at least a year to a year-and-a-half.
"We’d be giving this to normal people to prevent infection, so you must be sure," said Fauci, director of the National Institute of Allergy and Infectious Diseases.
Pharmaceutical company Gilead is testing a potential treatment and Fauci said, "We’ll know in a few months if it works."
A Gilead spokesperson said that the pharmaceutical company "is supporting two clinical trials of remdesivir in China led by Chinese authorities and a global clinical trial led by the U.S. National Institute of Allergy and Infectious Diseases (NIAID). Gilead has donated drug and provided scientific input for these studies, with results from studies in China expected in April. Gilead also is initiating two Phase 3 clinical trials of remdesivir in Asia and other countries globally with high numbers of confirmed COVID-19 cases."
According to Gilead, the trial led by NIAID will test patients in Washington state, which has been one of the states hardest hit by the coronavirus. Gilead has asked the FDA to take the "orphan drug" status off remdesivir, as other drug companies had objected to the orphan drug statute out of fear it would lead to price gouging and keep generic brands off the market longer.
In the process of obtaining a cure, the CDC has grown the COVID-19 virus in cell culture, which is necessary for further studies, including for additional genetic characterization and has sent it to the NIH's BEI Resources Respiratory for use by the larger scientific community.
"One important way that CDC is supporting global efforts to study and learn about the virus that causes COVID-19 in the laboratory is growing the virus in cell-culture so that researchers in the scientific and medical community can use the virus in their studies," the CDC informs on its website.
Once BEI expands the material that they received from the CDC, the CDC’s SARS-CoV-2 isolate (the virus the leads to the COVID-19 disease) can be requested by public and academic institutions that maintain appropriate facilities and safety programs, as well as have the appropriate expertise, as required by BEI, according to the CDC.
Some areas of COVID-19 research that public and academic institutions may study, according to the CDC, include:
- Antiviral research: This includes research aimed at testing the ability of existing or experimental antiviral medications to treat or prevent infection with SARS-CoV-2.
- Pathogenesis research: This includes research to determine the various ways the virus can be transmitted to a host, the severity of illness it causes in a host, how much virus is produced in the body, and what organs the virus can spread to within the body.
- Virus stability research: This is research that indicates how long the virus can survive under certain conditions, such as how long the virus can remain viable and infectious on surfaces, and the temperatures at which it can survive.
At two renowned Manhattan locations -- Mt. Sinai and at Columbia University -- experts are at the forefront of research that could potentially protect us from coronavirus.
Dr. David Ho is an internationally acclaimed researcher at Columbia University who is leading a team funded by the richest man in China, Jack Ma, to develop drugs and antibodies to combat the coronavirus.
"We've been working day and night, including weekends, for close to a month or so," Ho said.
The doctor believes his know-how from developing treatments for HIV and SARS in the 90s can help the team do the same for coronavirus.
"In the long run, I'm optimistic. The question is one of timing," Ho said.
Meanwhile, radiologists at Mt. Sinai -- the first in the country to analyze a series of CAT scans from coronavirus patients in China -- have identified patterns in the lungs that show how the disease affects people over the time, leading them to believe that the data can help with quicker diagnosis.
All the potential research is vital in successfully learning how to treat, prevent and even eradicate the disease.
Over time, if a promising vaccine is identified, it will undergo scrupulous laboratory testing, including careful examination and testing of the vaccine and its ingredients all in an effort to evaluate the vaccine's safety and how well it prevents a disease.
The general stages of the development cycle of a vaccine, as outlined by the CDC, are:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
As the CDC explains, clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and the vaccine is given to individuals who have certain characteristics such as age and physical health similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Additionally, many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
While there is currently no vaccine to prevent COVID-19, the CDC and the World Health Organization (WHO) maintain that the best way to prevent the illness is to avoid exposure to the virus and taking certain everyday actions to help prevent respiratory diseases, including:
- Avoid close contact with people who are sick;
- Avoid touching your face, including eyes, nose and mouth;
- Stay home if you feel ill;
- Cover your cough or sneeze with a tissue and then throw it away in the trash;
- Clean and disinfect frequently touched objects;
- Wash your hands with soap and water for at least 20 seconds;
- If water and soap are unavailable, use an alcohol-based hand sanitizer with at least 60 percent alcohol to cleanse your hands.
The new virus, first detected in China, has infected hundreds of thousands of people globally and caused tens of thousands of deaths.