The race against time is on as the world scrambles to find a vaccine to end the coronavirus pandemic, and everyone can finally return to their normal lives without fear of getting in contact with other people.
An unapproved coronavirus vaccine might have to be released by regulators.
Fauci's Timeline for a COVID-19 Vaccine
But when the US National Institute of Allergy and Infectious Disease (NIAID) director, Dr. Anthony Fauci, said that a COVID-19 vaccine is "on track" and will be released in 12 to 18 months, many were not as hopeful.
When looking at the average time, experts find a vaccine for diseases, a 12 to 18-month timeline looks impossible.
For one, the rotavirus vaccine was only approved after 26 years of testing and development.
That is because after a pharmaceutical company submits proof that the vaccine works after years of testing, the US Food and Drug Administration (FDA) will have to take at least a year to approve a vaccine.
With that, Quartz reported that in order to meet Fauci's timeline, a coronavirus vaccine might have to be released to the public without being formally approved.
The FDA has told the news outlet that they are considering the same authorization process for a COVID-19 vaccine as the treatments and tests that have been made available for the patients of this pandemic.
What this means is that a vaccine might be granted emergency use authorization (EUA) that allows various companies to distribute medications or tests to patients based on the submission of limited validation data.
Sinovac is Moving to Phase III
Meanwhile, the Chinese drugmaker of one of the leading coronavirus vaccine candidates, Sinovac Biotech Ltd., is currently in talks with regulators in different countries as well as the World Health Organization (WHO) to launch the third phase of their human clinical trials.
According to Bloomberg, the Beijing-based company is planning on doing their clinical trials in regions around the world where the novel coronavirus is fast spreading.
"To evaluate whether the vaccine can give protection, we need to study the relation between disease incidence and vaccination," Sinovac Biotech's CEO Yin Weidong said. "You can't do that when there are no cases."
Nevertheless, Yin did not specify which countries they are targeting but did hint that the US is an ideal location.
What Happens During This Stage?
During phase III, the company will have to use the vaccine with a group of volunteers, who will be monitored alongside a control group, or a group of people who will remain unvaccinated.
By doing this, they will be able to know whether the vaccine did help those who are vaccinated get immunity from the viral infection brought by SARS-CoV-2, or the novel coronavirus.
Sinovac Biotech is one of the three Chinese companies that are in the lead when it comes to finding a COVID-19 vaccine, along with the state-owned company China National Biotech Group Co. as well as CanSino Biologics Inc.
These companies each have leading candidates for a possible vaccine that can stop the novel coronavirus, which has already infected more than 3.8 million people around the world.
Yin confirmed that they have the vaccine ready, and if any country approves the clinical testing, they will immediately launch it.
