Then shortly after, a surprisingly quick response from the researchers at the San Diego lab. It took them just three hours to come up with an experimental vaccine for the coronavirus — a weapon against the illness which has infected thousands of people worldwide.
The vaccine has been shown to be very intriguing according to scientists who hope the vaccine will work like a piece of biological software, giving the human body instructions to launch a targeted attack in the form of T-cells and antibodies against the virus. So far, Inovio’s coronavirus vaccine has been tested on mice and guinea pigs. A clinical trial in humans will come next, perhaps as soon as this summer, which the company describes as a record time for trial to real-world use vaccination. The scientists say they feel a sense of urgency to get a vaccine to the public.
Even if all the Corona virus vaccine testing proves successful, it would still take time to manufacture enough to treat those who have been infected. Federal regulations require approval before bringing a new cure to market which could slow the process even further.
Clinical researchers will need to work fast. Since the first patient was identified in Wuhan on Dec. 31, the number of coronavirus cases has increased to over 10,000 in mainland China alone as of Friday morning, up from 800 reported the week before. These numbers are based on figures provided by the Chinese government which, could potentially be much higher than reported. While the new virus appears to be less deadly than the 2003 SARS outbreak, which sickened over 8,000 people and killed almost 800, it’s spreading much faster.
The next step is a preclinical toxicology study that assesses whether a drug is safe to use and is tested on animals, Bottazzi said. That usually takes three to six months depending on the study’s design, she said. If the evaluation is successful, scientists will then look to begin the first human trials, also known as phase 1 clinical trials, said Dr. Maria Bottazzi, co-director of Texas Children’s Hospital Center for Vaccine Development.
The center for disease control website shows the trial phases required for all new vaccines. These regulations are for the protection of the public and assuring vaccines have been thoroughly tested.
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
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 vaccine is given to people who have 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.
Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
As of today, United States health officials are working to fast track a coronavirus vaccine. The hope is to start human trials within the next three months, bringing the vaccine to market by summer time. Even during a fast-track, researchers getting a vaccine for the current outbreak could take up to a year, said Peter Hotez, co-director of Texas Children’s Hospital Center for Vaccine Development. That’s assuming a best-case scenario where researchers can immediately find something that works, the animal trials confirm it works and there are absolutely no complications in the upcoming human trials. “In the coronavirus, both the original SARS virus and Wuhan virus it’s called the receptor-binding domain of the spike protein, we would therefore use that as our ideal vaccine candidate.” said another lab scientist.
Last Tuesday, the World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said there is currently no vaccine or proven therapeutics to treat coronavirus, but global experts are collaborating to help stop the spread of the deadly virus, using a blueprint developed after the West African Ebola outbreak.