MAITLAND, Fla. — Rapid testing could provide a vaccine and treatment for COVID-19 as early as 2021.
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The Food and Drug Administration Monday said it is expediting reviews of tests to combat COVID-19.
“Our role is to determine if the tests developed by others provide accurate and reliable results, even when some would prefer that we let tests on the market without evidence that they work,” the FDA said.
It is not known what exactly will work as a vaccine or treatment for COVID-19.
Pharmaceutical companies are currently working with existing products and creating new mixes to see what may pass clinical tests and prove viable.
Carlos Orantes is CEO of Amplify Clinical, the company that owns Meridien Research and NeuroStudies in Central Florida.
The company is among thousands now working to be involved in clinical testing of potential vaccines and treatments for COVID-19.
“Right now, more than ever, we need everybody to be collaborating, to accelerate, to do it right and do it fast,” Orantes said. “Research is done right, but not fast because there’s so much risk involved and time involved, but right now we don’t have the time, we have to act quickly.”
Orantes said treatments and medications can typically take 7 to 10 years -- vaccines typically take 1-2 years -- and more than $1 billion to develop.
“(Treatment solutions are) sometimes a single product or a cocktail of products on the market, and the other pathway is vaccine, which there are none,” Orantes said. “Right now, there is tremendous work with pharmaceutical and biotechnology companies, first trying to understand the DNA makeup of COVID-19.”
Johnson & Johnson announced Monday it has made strides in developing a vaccine for COVID-19, which could be available by early 2021. The National Institute of Allergy and Infectious Diseases also started a clinical trial of a potential vaccine.
Orantes estimates many of the nation’s 75,000-80,000 clinical trial firms in the United States could have a role in testing potential vaccines and treatments.
“Treatment, depending on the severity of symptoms, treatment is limited,” Orantes said. “We will be preparing to test any vaccine candidates that come down.”
Sunday, the Food and Drug Administration issued an emergency authorization allowing hydroxychloroquine and chloroquine to be used for potential coronavirus treatment. The drugs have long been used for malaria.
Clinical trials often happen in phases.
In this case, pharmaceutical companies may experiment to come up with various treatments or vaccines, which companies like Amplify will then put through clinical trials.
Phase I is the very start of a test phase with a small group of human volunteers.
“That’s when it’s first introduced to humans to assess its safety, and once that is assessed, next is whether the vaccine does what it is supposed to do,” Orantes said. “Does it build up immunity, does it allow your body to fight the virus in the future?”
Each phase of the clinical can take months to conduct and analyze, with each round using a larger pool of volunteers.
Orantes said often finding people is the hardest challenge of a clinical research trial.
“Not a single drug can go to the market without having research done on participants,” Orantes said.
Orantes said he is hopeful his companies will be involved in direct clinical trials, expected to begin in several months, which will include the need of participants from across Central Florida.
It is not yet clear what kind of individuals would qualify for the trial, as Orantes said that would be determined by the guidance of the FDA and the specific vaccine or treatment being tested.