International- There are several dozen ongoing research efforts to develop a coronavirus vaccine, as the World Health Organization listed 35 candidates in a recent report.
- A top US health official has said it will take at least 12 months to 18 months to determine if any vaccine is safe and effective against this ongoing outbreak, which has killed more than 4,000 people and infected upwards of 114,000.
- A range of life sciences players are involved in the vaccine research, including massive pharma companies like Johnson & Johnson and Sanofi, tiny biotech companies, and academic research labs.
- We went through each effort to compile a timeline of what to watch for in coronavirus vaccine developments throughout 2020 and beyond. At least seven vaccines could begin human testing by the end of this year.
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There are several dozen research efforts to develop a coronavirus vaccine, ranging from pharmaceutical giants and tiny biotechs to academic centers and nonprofit groups.
Vaccine development has historically been a challenging multiyear process, requiring hundreds of millions of dollars to test a vaccine for safety and effectiveness. While this current epidemic is the third coronavirus outbreak of the 21st century - the first two being SARS and MERS - we still don't have any approved vaccines for coronaviruses.
The drug industry and health officials are now racing to respond to an ongoing outbreak that has killed more than 4,000 people and infected upwards of 114,000. Anthony Fauci, the longtime head of the National Institutes of Health's infectious disease unit, has repeatedly said it will take at least 12 months to 18 months to determine if a vaccine is safe and effective.
The World Health Organization (WHO) lists 35 vaccine candidates in the very first stages of research for this novel coronavirus. Here is a chronology of what to expect in the coming months for a potential coronavirus vaccine, from companies and organizations that have disclosed development timelines.
Spring 2020: The first trials begin in people
Once a group believes it has a viable potential vaccine, it usually begins human testing. The first clinical trials, called Phase 1 studies, are primarily focused on making sure the vaccine is safe and tolerable in a small sampling of healthy volunteers. These tests can also measure the vaccine's ability to induce an immune response.
The biotech upstart Moderna appears to be poised to be first to start trials of its potential vaccine in people. Its candidate, dubbed mRNA-1273, will be tested in 45 healthy adults at the Kaiser Permanente Washington Health Research Institute. The study, run by the National Institutes of Health, will test three dose levels: 25 micrograms, 100 micrograms, and 250 micrograms.
Kaiser researchers have already begun recruiting volunteers.
Two other vaccine developers - Inovio Pharmaceuticals and Novavax - have also stated they expect to start clinical testing this spring. Both are small biotechs that have no approved vaccines despite each being around for more than 30 years.
"Our plan is to start the US-based clinical trials for COVID-19 vaccine in April of this year," Inovio CEO Joseph Kim said at a March 2 White House roundtable meeting, "followed by, shortly thereafter, a trial in China, in South Korea."
That first study will test 30 healthy volunteers in the US, according to Inovio.
At the same White House meeting, Novavax CEO Stanley Erck said his biotech is aiming to start human testing of a coronavirus vaccine in May or June.
A German drugmaker called CureVac is aiming to start a Phase 1 trial at the beginning of June. Like Moderna, CureVac uses a messenger RNA platform that instructs cells how to make proteins. Altimmune, a tiny biotech based in Gaithersburg, Maryland, has also put out a timeline for a first human trial starting in August to test a vaccine delivered through the nose as a single-dose spray.
Summer 2020: We get our first look at whether the vaccines are safe
Over the summer, by Fauci's timeline, the first human data should become available for Moderna's experimental vaccine. Once that first study gets going, the NIH's Fauci said it should take roughly three months for data to accumulate to see if the vaccine is safe.
If it is, Moderna's vaccine could move into the next phase of clinical testing. This typically includes selecting one dose to bring forward, and then testing it in hundreds or even thousands of people instead of a few dozen.
More clinical results on safety could begin to trickle in in the second half of 2020. If companies like Inovio, Novavax, and CureVac deliver on their timelines to start Phase 1 testing in the coming months, that should lead to safety data by the fall, depending on how quickly these trials can enroll people.
Fall and Winter 2020: Johnson & Johnson plans to start a vaccine trial
Inovio, for instance, has said it plans to publish and present the initial data on its vaccine in the fall. By the end of 2020, the company has said it can produce 1 million doses of a vaccine candidate for future studies or emergency use.
Johnson & Johnson, the largest healthcare company in the world, has also stated it is aiming to bring a vaccine candidate into the clinic in November. Paul Stoffels, J&J's chief scientific officer, said the first versions of a potential vaccine are currently being tested in animals with positive results.
Another experimental vaccine from University of Queensland researchers is also on track to start human testing in the second half of 2020, according to a February 21 release.
2021 and beyond
At the most optimistic end of Fauci's timeline, a vaccine candidate could have data showing it's safe and effective at stopping the coronavirus in the first few months of 2021.
In Moderna's case, that means a potential data readout of its second human trial. Looking this far into the future, though, the unknowns mount quickly.
Typically, the US Food and Drug Administration requires an additional study to confirm a vaccine works, often in tens of thousands of people. It's unclear if there could be enough clinical evidence and urgency to deploy a vaccine as quickly as possible to forego such a test. That could be weighed against the need to ensure a vaccine works if it will be given to millions of healthy people.
J&J's Stoffels said the drugmaking giant plans to have early safety data on a vaccine in early 2021.
Other companies have also released timelines to start clinical testing in early 2021, including the French pharmaceutical giant Sanofi.
A small Danish biotech called ExpreS2ion Biotechnologies aims to start human trials within a year, after receiving just under $1 million from the European Union to accelerate development of a COVID-19 vaccine.
- Read more:
- The US is sprinting to develop a coronavirus vaccine or treatment. Here's how 9 top drugmakers are racing to tackle an outbreak that's spreading around the world.
- 'Crazy hours, short nights': The inside story of how a buzzy biotech upstart developed a potential coronavirus vaccine in record time
- We don't have any good treatments for the novel coronavirus right now, but scientists are racing to change that
- The $95 billion biotech Gilead just announced plans to test a promising potential coronavirus treatment in 1,000 people
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