- By the end of this year, there will likely be at least 50 coronavirus vaccine candidates in human testing, a Business Insider review found.
- There are 176 ongoing research efforts to develop a vaccine, according to the World Health Organization.
- Thirty-two vaccine candidates are now being tested in healthy volunteers around the world. And at least 15 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, Sanofi, and Pfizer to tiny biotechnology companies and academic labs.
- Here’s what to expect in 2020, with a timeline compiled of all the development efforts.
There are 176 coronavirus vaccine projects in the works, according to the World Health Organization.
Research has progressed quickly into human testing, with 32 vaccine candidates now being tried on humans in clinical trials around the world. A handful are in the final stage of testing, which could show if these vaccines work or not before the end of 2020.
There’s an urgent need for a vaccine, particularly in the US where the pandemic has not been brought under control. As of September 3, the US had recorded more than 6.3 million infections and about 190,000 deaths attributed to the virus.
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. Governments and nonprofits have given billions of dollars to drugmakers to expedite this process and do multiple steps of testing in parallel.
A Business Insider review found at least 15 more experimental vaccines are expected to enter the clinic in 2020. That means there will likely be around 50 coronavirus vaccines in human testing by the end of the year.
While research is moving with unprecedented speed, the biggest challenges still lie ahead in generating data showing a vaccine works, ramping up manufacturing, and distributing a shot around the world.
A leader of the US government’s vaccine efforts recently told BI he expects a shot will be widely available to Americans in April, May, or June of 2021.
Here’s the current state of play and what to expect in the coming months in the race for a vaccine.
The current state of play: 32 vaccines in human testing with results rolling in
By BI’s count, there are 32 vaccine candidates that have already started dosing clinical trial volunteers.
The research spans the globe, with vaccine studies recruiting and innoculating people in countries such as the US, UK, China, Russia, Germany, and India. The 100-some other vaccine projects remain in laboratory testing.
The frontrunners have already produced early human results and started the final stage of testing, called phase-three studies.
These trials recruit tens of thousands of volunteers and randomly give either an experimental shot or a placebo to determine if the shots prevent infection or disease. The speediest programs are all in phase-three trials and are led by Moderna, Pfizer, AstraZeneca, and CanSino Biologics.
Moderna and Pfizer both launched 30,000-volunteer trials in July to test vaccines based on messenger RNA (mRNA), a promising yet unproven technology that relies on the genetic code of the virus rather than samples of the particle. While there are no approved mRNA vaccines on market, several vaccines now in human testing are based on mRNA, including programs from the German biotech CureVac, Imperial College London, and Arcturus Therapeutics.
A key accelerant for several vaccine programs has been Operation Warp Speed, the US government’s effort to speed up and fund vaccine research. That initiative is backing six vaccines: Moderna, Pfizer, AstraZeneca, Novavax, Johnson & Johnson, and Sanofi/GlaxoSmithKline.
China has its own slew of domestically developed vaccine candidates now in human testing. CanSino Biologics has the most advanced effort and was approved in June for use by the Chinese military. Early data showed immune responses that were limited, as about half the volunteers had pre-existing immunity to the virus CanSino uses to deliver the vaccine.
The other Chinese vaccines were developed by the biotech Clover Biopharmaceuticals, the state-owned pharma Sinopharm, the private biotech Sinovac, the Chinese Academy of Medical Sciences, Chongqing Zhifei Biological Products, the Yunnan Walvax Biotechnology Company, and the West China Hospital of Sichuan University.
Many other countries have supported their own, homegrown vaccine candidates into human trials. These include the South Korean biotechs Genexine and Medytox, Japan’s Takara Bio, Russia’s Gamaleya research institute and consumer rights watchdog Rospotrebnadzor, Australia’s University of Queensland, Italy’s ReiThera, Canada’s Medicago, and India’s Zydus. All these programs have started human studies.
Fall 2020: The leading vaccines aim for emergency use authorization
The summer headed into the fall will be marked by a flurry of early human results for these vaccine programs. The vast majority of these studies will simply be determining if the shots are safe and promising enough to test in larger groups of people.
And more vaccines will start to be dosed in humans in September or October, including ones developed by United Biomedical’s subsidiary Covaxx, the San Francisco biotech VaxArt, Taiwan’s Medigen Vaccine Biologics, and a Kazakhstan research center.
As fall begins, the leading vaccine candidates could produce pivotal data that determine whether or not they actually prevent infection or disease. If positive, this could support US regulators to issue an emergency use authorization (EUA). This would likely allow a vaccine to be used in smaller groups of high-risk people, like healthcare workers or the elderly.
The three leading vaccine programs — led by Moderna, AstraZeneca, and Pfizer — are all aiming for an EUA this fall. AstraZeneca says it could have efficacy results as early as September, and similar best-case scenarios are to have data from Pfizer and Moderna as soon as October.
The speed of these trials depends on how quickly they enroll people and if they can focus recruitment on areas with high infection rates. Moderna and Pfizer both expect to finish enrolling 30,000 volunteers in September.
Advisory groups to the Centers for Disease Control and Prevention and the National Academy of Sciences are now determining how limited quantities of a vaccine would be distributed. Most experts anticipate people at highest risk of becoming sick, such as frontline workers, will be prioritized. Final recommendations are expected later this fall.
Winter 2020: More pivotal data from other top vaccines
While Moderna, Pfizer, and AstraZeneca form the first wave of potential vaccines, several more candidates are expected to quickly follow with crucial trial results.
Novavax and Johnson & Johnson both expect to start phase-three trials in September for their vaccines. Depending on fast these studies progress, both vaccines could produce pivotal data this winter, potentially before year’s end.
Sanofi and GlaxoSmithKline also started initial human testing in September for their joint vaccine project. The pharmas are two of the largest players in the vaccine space, and they hope to start a phase-three trial in December. They forecast it could be widely available as soon as the first 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.
Another of the world’s largest vaccine businesses has been relatively quiet in the early days. Merck, another giant in the vaccines business, unveiled two vaccine candidates on May 26. One has started a small trial while the other is set to enter the clinic before year’s end.
Finally, a few small biotechs are aiming to start human testing before the end of 2020: the Gaithersburg, Maryland-based AltImmune, Italy’s Takis Biotech, Europe’s Expre2sion Biotechnologies, the French biotech Valneva, Aegis Life, HDT Bio, NantKwest/ImmunityBio, and VBI Vaccines.
2021 and beyond
By the time 2021 starts there will likely be over 50 vaccines being tested in humans. There’s a decent chance there will be phase-three results from a few of the leading vaccine candidates.
But it’s unclear how regulators will react to that data. They will face difficult decisions in the face of a pandemic on how much data is enough to allow widespread use. Vaccine experts have already flagged the risk of political pressure, particularly in an election year, that could threaten the public’s confidence in an eventual vaccine.