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As the death toll from the coronavirus nears 300,000 worldwide, doctors and scientists are scrambling to develop multiple vaccines to stop the pandemic. But it’s not a competition. It might actually require several different vaccines manufactured and distributed by different labs in order to effectively eradicate COVID-19 from the planet, according to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Disease, who co-authored a paper about vaccines published May 11 in the journal Science.
Most health experts say that the virus won’t stop spreading until 60% to 70% of the world’s population is immune. Others say the only way to reach that level of immunity without a monumental death toll is through vaccines. Such is the opinion of Carl T. Bergstrom, a biology professor at the University of Washington and Natalie Dean, an assistant professor of biostatistics at the University of Florida, in a joint editorial published in the New York Times.
There are currently over 100 vaccines reportedly under development, with seven reportedly already in clinical trials earlier this month. That means there are more scientists working harder and faster on finding a vaccine than ever before in the history of pandemics. But even if one or more of the vaccines now in the works turns out to be effective, the FDA approval process typically takes a year or longer.
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It’s still too early to make predictions, but here’s what we know so far about the race to develop a coronavirus vaccine that may help usher in an end to the current pandemic.
One more note before we get underway. This article is intended to be a resource to help you understand current coronavirus vaccine research. It isn’t intended to serve as medical advice. If you’re seeking more information about coronavirus testing, here’s how to find a testing site near you (and here’s another way for Apple Maps users). Here’s how to know if you qualify for a test and why there aren’t any coronavirus at-home test kits yet. This story is updated frequently as new information comes to light.
Vaccine 101: What it is, how it works and how long to make one?
A vaccine is a medical treatment that protects you against a disease like the coronavirus or smallpox. For a deeper dive into how vaccines work, check out this in-depth coronavirus treatment explainer by CNET’s Science Editor Jackson Ryan. The short and sweet of it is that a vaccine tricks your body into thinking it’s already had the disease, so your body’s natural defense — the immune system — builds antibodies against it. Then, if you were to become infected, your body would call upon the antibodies to fight the virus before you feel sick.
Vaccines typically take about 10 to 15 years to develop. That’s in part because any new medical treatment needs to be thoroughly tested for safety before it can be distributed to millions or billions of people. The mumps vaccine took four years, which is widely considered the fastest vaccine approval in the history of infectious disease.
This month, the FDA fast-tracked a vaccine developed by Massachusetts-based biotech company Moderna, which is currently in Phase 2 clinical trials. The fast track process expedites FDA approval by opening more lines of communication between developers and regulators. It also parses out the review process incrementally, so the lab doesn’t have to complete and submit all sections of the application at once.
Vaccines, antibody tests, treatments: The science of…
The current coronavirus vaccine landscape
This April, the White House began organizing “Operation Warp Speed,” according to Bloomberg, a sort of coronavirus vaccine task force that has identified 14 vaccine projects that it will focus on fast-tracking. The “Warp Speed” project itself, which the White House acknowledged during an April press briefing, has a stated goal of readying 300 million doses of vaccine to be available by January 2021. That’s a bit faster than the 12- to 18-month estimated timeline proposed by Fauci, the NIAID director.
As of this writing there are over 100 vaccines under development in countries around the world, including the US, UK, Germany, Japan and China. Twelve are either already in clinical trials or starting in the next few months. Out of those 12, one particular standout seems to be Oxford University. Scientists there say their vaccine could be ready by the fall of 2020.
How good are the odds for finding a vaccine?
Statistically, only about 6% of vaccine candidates ever make it through to market, according to a Reuter’s special report, and not just because they don’t work. There’s a whole litany of problems that could cancel even a promising candidate. Take, for example, what happened when scientists tried to develop a vaccine for SARS — it backfired and actually made people more susceptible to the disease. The same thing happened with a vaccine for Dengue fever. To make matters worse, coronaviruses are a large class of viruses and so far there are no vaccines for any of them.
However, this particular coronavirus, SARS-CoV-2, has some unique traits that may help researchers working on a vaccine. For example, some viruses, like the flu, mutate quickly and often, which is why there’s a new flu vaccine every year. Early evidence suggests that the coronavirus doesn’t appear to do that. Although some researchers have hypothesized that a more highly-contagious strain has recently developed, others aren’t so sure. Either way, it’s thought that the virus has not yet mutated significantly enough to disrupt vaccine development, nor is it expected to, though it’s too soon to say for certain, and there are still many unknowns about the virus’ behavior.
Fighting coronavirus: COVID-19 tests, vaccine research, masks, ventilators and more
What steps does a vaccine have to go through to get approved?
Rules and regulations vary by country, but, generally speaking, most industrialized nations have similar protocols for approving a vaccine. The following path is how vaccines are approved in the US under the Food and Drug Administration:
- Before clinical trials can begin: Once a laboratory has researched and developed a potential vaccine, which includes testing it in animal models and working out manufacturing and quality control processes, it can apply to the FDA to start clinical trials.
- Phase 1 clinical trials: The vaccine is tested for safety and effectiveness in a small number (dozens) of closely monitored subjects.
- Phase 2 clinical trials: Various dosages of the vaccine are tested on hundreds of human subjects.
- Phase 3 clinical trials: Thousands of subjects are enrolled to measure the overall effectiveness of the vaccine.
- If a vaccine passes all three phases: The lab must then apply to the FDA for a license to produce and distribute the vaccine. That application is reviewed by both FDA and non-FDA scientists.
- If approved: The lab begins producing the vaccine while the FDA closely monitors production.
- Phase 4: Although at this point the vaccine may be released to the market, many vaccines continue with what’s called Phase 4 studies, during which the FDA continues to review the safety and efficacy of the vaccine.
What happens if we never find a coronavirus vaccine?
The longer we go without a vaccine, the more likely focus will shift toward treatments, such as the experimental antiviral drug remdesivir, which has reportedly shown promising results. With effective therapeutic treatments, many viruses that used to be fatal are no longer death sentences. Patients with HIV, for example, now can expect to enjoy the same life expectancy as non-HIV-positive individuals, thanks to tremendous advances in treatment.
Without a coronavirus vaccine, the road back to normal may be harder and longer, but not necessarily impossible. Coronavirus testing, including antibody testing, and contact tracing efforts would probably need to intensify.
Lockdown measures are already lifting slowly, although depending on people’s behavioral practices and a potential resurgence of infections, cities and states may bring back certain quarantine measures, including requiring face masks and social distancing. Eventually, the global population may reach the 60% to 70% rate required for herd immunity to protect those who aren’t immune.