Coronavirus Vaccine Development, Explained
Experts warn COVID-19 outbreaks could be a cyclical event
Apr 15, 2020
While some infectious disease experts argue over the time it would take to develop a coronavirus (COVID-19) vaccine, others assure that the cure could be produced within the next 12 to 18 months, as concern grows that the infection could resurface even after vaccination.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and a key member of President Donald Trump’s coronavirus task force, previously dismissed the president’s claim that the vaccine could be out within four months.
Fauci, who is currently in Trump’s bad graces for criticizing the administration’s delayed call to action to contain the spread of COVID-19, had stated that “it will take at least a year to year and a half to have a vaccine we can use.”
Dr. José Morey, chief medical innovation officer at Liberty BioSecurity, also known as the Intergalactic Doctor, discussed with THE WEEKLY JOURNAL the process to develop a vaccine and the possibility of generating durable immunity to the infection.
According to the Puerto Rican innovator, the clinical development of a vaccine is a three-stage process.
During the first phase, which typically takes two to four months, scientists take a small group and inject some with the vaccine and others with a placebo. Then, they determine the percentage of people who actually receive and respond to the vaccine.
“What we are looking for is for the vaccine to cause no negative side effects. In an average study, the first phase will only have around 20 to 40 people. In this situation it is slightly different because we have an emergency,” Morey explained.
Phase II requires a larger group of people and aims to determine if the vaccine is effective at tackling the virus.
After the development and distribution stages, it will take some additional time for people’s immunological systems to respond accordingly. The Centers for Disease Control and Prevention (CDC) point out that during this phase the vaccine is given to people who have characteristics, such as age and physical health, similar to those for whom the new vaccine is intended.
Lastly, during phase III, the shot is given to thousands of people and then tested for efficacy and safety, after which the vaccine would undergo regulatory review and approval, manufacturing and quality control. Even after the vaccine is administered, it takes some time for it to work.
“It takes several weeks, sometimes months, for the immunological system to create the antibodies against a virus. And sometimes… it may require more than one vaccine, like with children; sometimes you have to vaccinate them one time and then give them another vaccine,” Morey said.
He added, “something that can happen within the next six to 12 months, if we want good results, is that we may be able to use the data that we are obtaining to create vaccines for people in high-risk situations, such as doctors, nurses and people who are in the front lines.” However, Morey noted that this remedy would not be available to patients with preexisting medical conditions because it would require more studies.
Morey noted that, in some cases, phases I and II are conducted simultaneously based on preliminary data. This strategy is currently being implemented by CanSino Biologics Inc., a China-based global vaccine company which kicked off its first in-human trial with volunteers in the city of Wuhan, where the virus originated, roughly three weeks after its emergence.
Meanwhile, Moderna, a Massachusetts-based biotech company, and the first to start testing a COVID-19 vaccine on humans, claims that it could enter phase II in the spring or early summer.
The need for a vaccine has become increased as countries continue to grapple with the pandemic. The U.S. recently became the country with the most cases of coronavirus, with more than half a million confirmed cases and over than 22,000 deaths at the time of this writing, for a mortality rate of roughly 4 percent.
Morey said that these numbers should be taken “with a grain of salt,” given that there is no real number on how many people are actually infected or have died from the virus because there haven’t been enough tests performed. In addition, Morey stated that some reports have indicated that 20 to 30 percent of results are false negatives, akin to the HIV/AIDS outbreak in the late 20th century.
COVID-19 Could Reemerge Seasonally
After observing coronavirus outbreaks in other nations as they enter their colder seasons, such as Southern African countries, health experts contend that this could be an indication that COVID-19 will be a seasonal infection, just like other viral respiratory diseases like influenza (flu). Fauci himself spoke about this scenario.
“There is a possibility that this is something that we will be seeing just like influenza, that we will see it every winter whenever the cold season comes. When humidity drops, we may see that this will continue to come,” Morey said.
He added, “but this could be just like the flu, that we can create a vaccine and people are also going to be able to develop a herd immunity simply by being around the virus; that eventually, we are going to be able to conquer it at some level. Maybe it won’t be completely eradicated, but we will be able to manage and control it so that it doesn’t have the effect it is having now.”