Newcases are on the rise across the US. This has prompted at least 21 state governments to pause or roll back their reopening plans in an effort to curb the emergence of a . Many experts say the only way to bring an end to the pandemic is through an effective vaccine. For people in the US who’ve grown weary of , and the , it can’t come soon enough.
So, how close are we to a vaccine for COVID-19? Possibly closer than you think.
Vaccines usually take years — sometimes decades — to develop, approve, manufacture and distribute globally. However, there have never been so many doctors and scientists working this hard and fast on one. Just seven months since SARS-CoV-2 was first discovered, 19 vaccine candidates are already in human trials, with 130 more still being developed. Here’s what’s happening now.
This article updates frequently and is intended to be a general overview, not a source of medical advice. If you’re seeking more information about coronavirus testing,near you. Here’s and .
Latest COVID-19 vaccine news
- A COVID-19 vaccine developed at Oxford University has already been given to 10,000 volunteers in the UK, where coronavirus cases are declining. It began large-scale Phase 3 human trials in Brazil July 1 and is set to start a similar trial in South Africa soon after, where infection rates are surging.
- US biotech company Moderna has delayed Phase 3 trials of its vaccine candidate, which were supposed to start in early July, but says trials will still begin before August.
- A vaccine candidate in Singapore might create immunity to the coronavirus, and could potentially treat active infections. Trials are set to begin in August.
- New minimum standards set by the FDA includes the requirement that a vaccine must be at least 50% better than a placebo at preventing COVID-19 in order for it to be approved.
- Pharmaceutical giant Pfizer released encouraging preliminary data on its coronavirus vaccine on July 1, causing Pfizer’s stock to jump.
- A vaccine candidate has been approved for use by the military in China, even though Phase 3 trials haven’t started yet.
- Scientists tracking the coronavirus genome report that, unlike other viruses such as the flu, this coronavirus doesn’t change quickly, which means mutations are unlikely to slow the development of a vaccine.
What is Operation Warp Speed?
Operation Warp Speed is a sort of coronavirus vaccine task force that has identified 14 vaccine projects to focus on fast-tracking. The Warp Speed project has a stated goal of readying 300 million doses of vaccine to be available by January 2021, which coincides with Fauci’s estimation.
Talking to JAMA Editor in Chief Howard Bauchner in June, Fauci said Operation Warp Speed is financially 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.
Thanks to the Operation Warp Speed vaccine acceleration program, Fauci said he expects the US will have “hundreds of millions of doses” of the vaccine ready to deploy by early 2021. However, if a significant percentage of Americans refuse a coronavirus vaccine, the US might not reach the critical level ofneeded to end the pandemic, he said during an interview posted on YouTube on June 28.
The presumed frontrunners: Oxford University and Moderna
Scientists at Oxford University in the UK say that a vaccine being developed there could be ready by the fall of 2020. Oxford is working with pharmaceutical giant AstraZeneca. Phase 3 trials are currently underway in the UK and Brazil and are set to begin in South Africa soon.
Scientists say in a paper that the 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. However, Oxford vaccinologist Sarah Gilbert has assured British Parliament she is optimistic that the Oxford vaccine will be effective and give patients lasting immunity. You can read more about this effort, called ChAdOx1 nCoV-19, at AstraZeneca’s website.
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 its stock to soar. Soon after, however, scientists cast doubt on the company’s data, causing the same stocks to falter. Moderna announced in a July tweet that Phase 3 trials have been delayed, but are still expected to begin in July.
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 in 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.
Coronavirus reopenings: How it looks as lockdowns ease around the world
See all photos
Will there be just one vaccine for everyone?
We won’t know for a long time, but Fauci co-authored a paper about vaccines published May 11 in the journal Science that suggests it might take several different vaccines made and distributed by different labs in order to effectively eradicate COVID-19 from the planet.
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 outby 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 — . 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. 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.
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, 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.
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.
Fighting coronavirus: COVID-19 tests, vaccine research, masks, ventilators and more
See all photos
However, this particular coronavirus,, 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.
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.
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, 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., including , and efforts would need to intensify, experts say.
Lockdown measures are already, although with a potential , cities could bring back certain quarantine measures, including requiring and . Eventually, the global population may reach the 60% to 70% rate required for to protect those who aren’t immune.