Experts are hopeful that a vaccine against the SARS-CoV-2 virus will become available sooner rather than later.
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Coronavirus cases are still increasing in a third of US states, according to new data reported over the weekend — from South Carolina and Florida to Arizona and Illinois — raising concern that a second wave of the virus could soon be building up momentum. For people in the US who’ve grown weary of lockdowns, social distancing and the polarizing issue of face masks, a vaccine can’t arrive soon enough.
In the meantime, some or all of the measures meant to curb the spread of COVID-19 could return, even as schools begin to open and sports tentatively resume. (Although large-scale events like music festivals, tech conferences and the Olympics continue to be on hold.) What will it take to get a coronavirus vaccine?
The answer, unfortunately, is time. Vaccines typically take years — sometimes even decades — to develop, approve, manufacture and distribute globally. That said, there have never been so many doctors and scientists working this hard and fast at it. Just six months since SARS-CoV-2 was first discovered, at least half a dozen vaccine development projects are already reporting encouraging progress, with many more in development.
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Director of the National Institute of Allergy and Infectious Disease Dr. Anthony Fauci said he expects the US will have “hundreds of millions of doses” of vaccine ready to deploy by early 2021 in a June 2 interview with Journal of the American Medical Association editor in chief Howard Bauchner.
Fauci said he is personally working with four or five different vaccine projects that are either in human trials or about to be. One of those projects, spearheaded by Massachusetts-based biotech company Moderna, has announced it will enter broad Phase 3 clinical trials this July, which could include as many as 30,000 human participants, according to Fauci. Other vaccine candidates, including those from Oxford University and AstraZeneca, Pfizer and Chinese vaccine developer Sinovac aren’t far behind.
One more note before we get underway. This article is updated frequently as new information comes to light, and is intended to be a general overview, not a source of medical advice. If you’re seeking more information about coronavirus testing, here’s how to find a testing site near you. Here’s how to know if you qualify for a test and how to get an at-home coronavirus test.
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The presumed frontrunners: Moderna and Oxford University
Moderna has been making headlines for its coronavirus vaccine development — both positive and negative. Early reports that Moderna’s first trials showed promise for immunity caused Moderna’s stock to soar. Soon after, however, scientists cast doubt on the company’s data, causing the same stocks to falter.
Moderna is a beneficiary of the US Food and Drug Administration’s program to fast-track vaccines. The fast-track process expedites approval by allowing select labs to submit their review process by phases, rather than submitting all sections of the application at once, which is the usual way. The company ran Phase 1 clinical trials and reported preliminary data that it says supports the move to a larger Phase 2 trial, which is currently ongoing. Phase 3 is reportedly slated for July. You can learn more about Moderna’s vaccine candidate, mRNA-1273.
Another vaccine is under development at Oxford University in the UK. Scientists there say that vaccine could be ready by the fall of 2020. Oxford is working with pharmaceutical giant AstraZeneca. Their vaccine candidate is slated to begin simultaneous Phase 2 and Phase 3 trials this month.
Scientists say in a paper that results from Oxford’s trials on mice and rhesus monkeys are mixed, however, speculating that humans who eventually take the vaccine might still be able to spread the virus. You can read more about this effort, called ChAdOx1 nCoV-19, at AstraZeneca’s website.
Will there be just one vaccine for everyone?
We won’t know for a long time, but Fauci has suggested that it might take several different vaccines made and distributed by different labs in order to effectively eradicate COVID-19 from the planet. Fauci co-authored a paper about vaccines published May 11 in the journal Science.
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Vaccines: How long it usually takes to make them
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.
However, talking to JAMA editor in chief Howard Bauchner, Fauci said the US government is backing efforts to start manufacturing doses while clinical trials are still ongoing. That means, if and when those vaccines do get approved, there will already be a store of doses ready to distribute nationally.
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Why a vaccine may be key to ending the pandemic
Most health experts predict that the virus won’t stop spreading until 60% to 70% of the world’s population is immune, and they 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.
What else is happening with coronavirus vaccine development
There are currently over 100 vaccines reportedly under development in countries around the world, including the US, UK, Germany, Japan and China, with 13 reportedly already in clinical trials as of last 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.
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, which coincides with Fauci’s estimation.
Scientists from around the world are working toward developing a vaccine. So far 12 projects have either started or will soon start clinical trials.
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 Reuters 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 contagious strain has 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.
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What steps do vaccines 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 FDA:
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.
Until there’s a vaccine, expect safety precautions like face masks and social distancing to be a part of everyday life.
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, can now 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 life” may be harder and longer, but not necessarily impossible. Coronavirus testing, including antibody testing, and contact-tracing efforts would need to intensify, experts say.
Lockdown measures are already lifting throughout the world, although with a potential second wave of coronavirus infections, cities could 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.