- There are to develop a coronavirus vaccine, and at least 28 are expected to start human testing in 2020.
- Ten vaccine candidates are now being tested in healthy volunteers around the world. Eighteen more programs are aiming to start clinical trials this year, a Business Insider review found.
- While these vaccines are progressing with historic speed, the biggest challenges lie ahead. Drugmakers will have to prove a candidate works in humans, ramp up manufacturing, and ultimately distribute the serum to the world.
- The research efforts range from massive pharma companies like Johnson & Johnson and Sanofi to tiny biotechnology companies and academic laboratories.
- Here's what to expect in 2020, with a timeline compiled of all the development efforts. By year's end, nearly 30 experimental vaccines are expected to have entered the clinic.
- Visit Business Insider's homepage for more stories.
There are 125 coronavirus vaccine projects in the works, according to .
2020欧洲杯足彩外围appResearch has progressed quickly into human testing, with 10 leading vaccine candidates now being tried on humans in clinical trials around the world.
A Business Insider review found this is just the tip of the iceberg: at least 18 additional vaccines are expected to enter the clinic in 2020. Dozens of additional programs have yet to disclose development timelines.
Vaccine development is historically a challenging multiyear process, aimed at ensuring a candidate is safe and effective before giving it to millions of healthy people.
While early research is moving with unprecedented speed, the three biggest challenges lie ahead. Those are generating human data that show a vaccine works, ramping up production to produce gigantic quantities, and distributing a vaccine across the world.
Top health officials, including Anthony Fauci, the top infectious disease experts in the US, have estimated it will take at least 12 to 18 months to fully develop and test any vaccine. Some vaccinologists and industry analysts are "deeply skeptical" of that timeframe.
2020欧洲杯足彩外围appHere's a chronology of what to expect in the coming months for potential coronavirus vaccines, from companies and organizations that have put forward development timelines.
Spring 2020: The first human trials start, while most research remains in labs
The vast majority of the 100-some vaccine projects are still in laboratory testing. Ten vaccines are now being tested in humans.
The three US-based trials are testing vaccines from Moderna, Pfizer, and Inovio Pharmaceuticals.
Moderna's vaccine was the first to produce early human results, starting its clinical trial on March 16. People given Moderna's vaccine registered levels of antibodies that may suggest protection against the virus, but more testing will be needed. Moderna to soon start a second human trial, randomizing 600 people to receive either the vaccine or a placebo.
The pharma giant Pfizer and German biotech BioNTech have teamed up to speed up the work on BioNTech's messenger RNA (mRNA) vaccine, with early human testing underway in Germany and the US.
mRNA is the same platform that Moderna and a few other biotechs are using to quickly develop vaccines. The technology holds tremendous promise in relying only on the genetic code of a virus rather than samples of the particle. But it remains unproven, with no approved mRNA vaccines on market.
Inovio is testing a DNA-based vaccine, entering the clinic on April 62020欧洲杯足彩外围app. The Maryland biotech Novavax in Australia on May 25.
China leads the world with five vaccine candidates now being tested in humans. CanSino Biologics has the most advanced effort, entering mid-stage clinical trials in April. The first human data2020欧洲杯足彩外围app was released on May 22 in The Lancet, a top medical journal. While the results support additional trials, they also showed most participants registering some level of side effects, with about 8% suffering from a severe fever. CanSino's Phase 2 trial is not testing the strongest dose used in the small safety study, likely because of the increased rate of side effects.
2020欧洲杯足彩外围appIn the UK, a vaccine developed by University of Oxford researchers is , with half receiving the experimental drug and half given a control vaccine. The British pharma giant AstraZeneca has joined that program, taking the led on a global development and production strategy.
2020欧洲杯足彩外围appCureVac is another German biotech working on an mRNA vaccine. The company is aiming to start human trials in June. Its vaccine candidate showed it can yield a strong immune response in laboratory testing, the company
The UK government is financially backing another vaccine program beyond U-Oxford. Researchers at Imperial College London have received funding from the government that will help advance their coronavirus vaccine into initial human studies in June, .
The tiny biotech Stabilitech Biopharma has also stated it plans to start human testing of an experimental vaccine pill by June. But the British biotech is also to support that research.
Summer 2020: More results roll in, presenting a critical test for early efforts
Beginning in June, expect a flurry of early human results to start coming in. None of these trials are designed to definitively test if a vaccine works or not, as these small studies are more focused on making sure it is safe enough to then start testing in larger human populations.
Moderna anticipates providing additional data with longer follow-up in more people, about 100, throughout the summer. Its second trial in 600 people should also provide early safety data by July, potentially allowing the biotech to start a late-stage efficacy trial in July.
Moderna isn't waiting for positive results to ramp up its production capacity, having inked a nearly $500 million deal with the US government to do so. Moderna also with a Swiss manufacturer to pump out more vaccine batches beginning in July, with the goal of building annual production capacity up to 1 billion doses.
Inovio's vaccine expects early safety data in June. If positive, those results could support an efficacy-focused trial beginning this July or August, .
2020欧洲杯足彩外围appThe AstraZeneca-Oxford program will also produce safety and preliminary efficacy data in the next few weeks. This study has an adaptive design, where it can quickly expand to enroll up to 5,000 people over the course of 2020. The US is also planning to launch its own 30,000-person study with AstraZeneca's vaccine sometime this year, if early data is positive.
Pfizer's collaboration with BioNTech should also bring early human data in late May or early June. The companies are testing four vaccine constructs in its early testing, so the early results should help identify the most promising candidate to take forward.
Novavax is also expecting safety and immunogenicity data in July from its first study in Australia. The biotech plans to start a second portion of this study in July with more volunteers across multiple countries including the US. This latter portion will test if the vaccine can actually reduce the disease.
While those leading efforts advance into late-stage clinical trials, many small programs will be entering the clinic around the globe this summer. These efforts face massive uncertainties on how they will be able to rapidly scale up manufacturing, given a lack of resources and experience in mass-producing vaccines.
2020欧洲杯足彩外围appIn Australia, University of Queensland researchers have outlined plans to start human testing as soon as July.
A trio of three tiny European biotechs — Reithera, Leukocare, and Univercells — have banded together on a vaccine program with the goal of starting this summer a human safety trial in Italy.
The San Francisco biotech VaxArt is preparing a potential oral vaccine taken as a tablet instead of a traditional injection, which could start a safety trial this summer.
2020欧洲杯足彩外围appDr. Patrick Soon-Shiong's biotechs ImmunityBio and NantKwest also have an adenovirus-based vaccine that should start human testing this year, likely by the summer and potentially as early as June.
The Canadian company Medicago is after its vaccine showed it could produce antibodies in mice after one dose.
Singapore's government is working with Arcturus Therapeutics, a small San Diego biotech, on an mRNA vaccine expected to start human trials this summer in Singapore.
Fall and Winter 2020: The earliest vaccine efforts eye the potential for emergency use
Three leading vaccine programs are aiming for potential emergency use authorization this fall. This regulatory OK would likely make the vaccine available to limited populations at high risk of infection or severe disease, such as healthcare workers and the elderly.
The US FDA has never allowed emergency use of a vaccine before, and it is unclear what exactly would be required to make that happen. But the vaccine programs of Moderna, AstraZeneca, and Pfizer are all gunning to be ready this fall if needed.
2020欧洲杯足彩外围appSome of the world's other largest drugmakers are hoping to bring their vaccines into the clinic later this year, forming a second round of vaccine development.
2020欧洲杯足彩外围appThis includes a collaboration between two of the world's largest vaccine businesses, Sanofi and GlaxoSmithKline. This duo is aiming to bring a protein-based vaccine from Sanofi combined with GSK's adjuvant, which could boost an immune response, into human testing in the second half of 2020. They forecast it could be widely available in the second half of 2021.
Sanofi has an additional collaboration with a tiny Massachusetts biotech for an mRNA vaccine aiming to start human trials in the fourth quarter of 2020.
Johnson & Johnson, the world's largest healthcare company, is also aiming to start testing its coronavirus vaccine in humans in September. Paul Stoffels, J&J's chief scientist, told Business Insider2020欧洲杯足彩外围app a first trial would likely enroll a few hundred people and produce data before year's end.
Merck, another giant in the vaccines business, unveiled two vaccine candidates2020欧洲杯足彩外围app on May 26 it plans to bring into the clinic before year's end.
2020欧洲杯足彩外围appFinally, a few small biotechs are aiming to start human testing in the second half of 2020: the Gaithersburg, Maryland-based AltImmune, Italy's Takis Biotech, Europe's ExpreS2ion Biotechnologies, and the French biotech Valneva.
2021 and beyond
By the time 2021 starts there will likely be nearly 30 vaccines being tested in humans.
We still won't fully know how well they work or how safe they are in humans. Regulators will face difficult decisions in the face of a pandemic on how much data is enough to allow them to be used beyond clinical trials.
2020欧洲杯足彩外围appJ&J says its vaccine could be available for emergency use in early 2021. University of Queensland researchers have also stated their vaccine could be used in healthcare workers or vulnerable populations in early 2021.
Sanofi and GSK's vaccine is aiming to be available in the second half of 2021.
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