The US is gearing up to test the first coronavirus treatments and vaccines. Here's how 6 top drugmakers are racing to tackle an outbreak that's spreading around the world.

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  • As the coronavirus outbreak has exploded into a global public-health emergency, leading drugmakers have begun researching treatments and vaccines to stop the virus.
  • The small biotech Moderna has leaped to the front of the race, sending a vaccine candidate to US health officials to start testing in people. Pharma giants like Johnson & Johnson and Sanofi are also in the early stages of advancing vaccine candidates.
  • The National Institutes of Health is running a trial to test a drug from Gilead Sciences as a treatment for the virus that causes the disease known as COVID-19.
  • The virus’ rapid spread has instilled urgency in developmental efforts, which are set to test how quickly these companies can identify and mass-produce effective treatments.
  • Here’s a rundown of the latest on the companies’ development strategies, which include repurposing existing drugs as well as creating new vaccines based on the genetic understanding of the novel virus.
  • Visit Business Insider’s homepage for more stories.

As a coronavirus outbreak that originated in Wuhan, China, has now killed more than 2,700 and infected upwards of 81,000 people, multiple drug companies are working with US health authorities to develop treatments.

The companies — including industry giants like Johnson & Johnson, Sanofi, and Gilead Sciences — are taking a variety of approaches. Some are developing vaccines from scratch using info about the virus’ genetic code. Others are testing existing drugs as near-term treatment options.

While drug development is typically a multiyear process that faces significant hurdles, US health officials have been pushing speedy testing timelines. Anthony Fauci, the director of the National Institutes of Health’s (NIH) infectious disease center, said he hoped to start testing vaccine candidates in humans by mid-April.

 

That urgency stems from an outbreak that was recently declared a global public-health emergency by the World Health Organization. While the vast majority of infections have happened in China, the virus has spread to more than two dozen countries, including the US.

Here’s how six leading drugmakers are attempting to fight the virus.

Moderna is leading the vaccine race and in-human trials could start by April

While other leading drugmakers have a long history in developing drugs and bringing them to market, the buzzy biotech Moderna is testing a new technology platform against this public-health threat. 

The $10 billion biotech went public in 2018 based on the promises of its novel genetic approach to therapeutics. And under the pressure of this outbreak, Moderna has responded in record time, at least initially.

The platform, called messenger RNA, is being used to develop a vaccine candidate with financial support from the NIH and the Coalition for Epidemic Preparedness Innovations. 

The first batch of its coronavirus vaccine, dubbed mRNA-1273, has been shipped to NIH officials, who will lead the first clinical trial, the company said in a February 24 statement. 

That first study of Moderna’s drug will test three doses of the vaccine in health adults, studying to see if the vaccine is safe and creates an immune response. The NIH’s Fauci has repeatedly said testing could begin by mid-April, pending any setbacks, with initial human data coming a few months after that. 

The trial is currently estimated to start on March 6 and enroll 45 people, according to a clinicaltrials.gov posting.

The biotech believes its technology can accelerate the process and quickly produce a vaccine against the coronavirus.

“It’s really a big step forward compared to traditional vaccines,” Moderna CEO Stephane Bancel told Business Insider, adding that drugmakers typically invent a manufacturing process almost from scratch for each vaccine.

Gilead Sciences wants to repurpose an existing virus-fighting drug

The California biotech Gilead is looking into repurposing an antiviral drug that was previously tested against Ebola.

Multiple clinical trials in China and the US are now underway testing that drug, called remdesivir. US health officials said on February 25 that a study had started based at a medical center in Omaha, Nebraska.

The NIH’s infectious disease unit is leading the US study, which will randomly assign patients to either Gilead’s drug or a placebo.

The study is only open to patients with a laboratory-confirmed infection of the coronavirus that is severe enough to require a ventilator or supplemental oxygen. People with mild, cold-like symptoms from the coronavirus will not be included in the study, according to the NIH.

The studies in China are aiming to enroll more than 700 patients, but the strict eligibility criteria has limited initial enrollment, The Wall Street Journal reported on February 18.

A single case reported in The New England Journal of Medicine initially stirred excitement about remdesivir’s potential, but experts have stressed that clinical trials are needed to validate those findings. 

“Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” NIH’s Fauci said in a February 25 statement. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Gilead also said the drug has shown activity in animals against similar viruses like MERS and SARS.

Johnson & Johnson is testing 5 ideas for a vaccine

The largest healthcare company is testing five ideas in hopes of finding an effective vaccine against the coronavirus, a leading research-and-development executive told CNBC on January 27. 

“We are comfortable that we can create a vaccine and scale it up,” Paul Stoffels, the chief scientific officer at Johnson & Johnson, said in a recent television interview.

The pharmaceutical firm is no stranger to developing vaccines for emerging crises. In the past, it has used its platforms to develop an investigational Ebola vaccine that has now been given to thousands of people in Africa, as well as vaccine candidates for HIV and respiratory syncytial virus.

Additionally, the company donated 350 boxes of Prezcobix, its HIV therapy, to Chinese hospitals and health officials. J&J said the motivation for the donations stemmed from anecdotal accounts that a certain type of antiviral has worked against similar coronaviruses in the past, such as SARS, or severe acute respiratory syndrome.

The pharma is also working with the US Biomedical Advanced Research and Development Authority (BARDA) to screen a range of antiviral medicines as treatments. BARDA expanded its partnership with J&J on February 18. 

Sanofi looking to build on top of SARS vaccine candidate 

Sanofi has also started work with BARDA to progress a coronavirus vaccine. 

“We are confident in working with BARDA, together we will be able to address this faster than going at it alone,” David Loew, Sanofi’s global head of vaccines, said on February 18.

In particular, the French pharma giant is hoping it can speed up its efforts by using vaccine research related to the 2002-2003 SARS outbreak. Sanofi has a SARS vaccine candidate it can work with to counter COVID-19. 

But that experimental vaccine has yet to be tested in humans, and Sanofi executives said it would take about 12-18 months to begin human testing in this case.

Read more: Pharma giant Sanofi is developing a vaccine to fight the deadly coronavirus outbreak using its previous research on SARS

Regeneron is pursuing 2 routes to find a coronavirus treatment

Regeneron and the US Department of Health and Human Services on February 4 added the coronavirus to an agreement to develop antibodies against the leading public-health threats.

With that expansion, the biotech-industry leader has started its efforts to counteract the virus.

A coronavirus treatment could enter a clinical trial in a matter of months, George Yancopoulos, Regeneron’s chief scientific officer, said Thursday.

“We’re already scaling up one set of potential antibody treatments that could be available for testing or for compassionate use in patients within a few months, as well as a new set of treatments that could be available soon thereafter,” Yancopoulos said. 

Regeneron, which is based in Tarrytown, New York, worked with US health officials in developing a treatment that showed some success in countering Ebola.

For this new coronavirus, Regeneron is exploring two routes, a company spokesperson told Business Insider on February 4.

First, Regeneron researchers will work to discover new antibodies against the disease. To speed up early testing, the biotech plans to test the drug candidates in genetically engineered mice that have immune systems similar to people.

Regeneron approached Ebola in a similar way. It took about six months for the company to develop the new treatment and validate its effectiveness in animals and then another six months to become ready for use in humans, a company spokesperson said.

The second approach is to test existing antibodies against the virus, such as a previous treatment Regeneron developed for MERS, or Middle East respiratory syndrome. The new coronavirus has shown differences with MERS, so the likelihood of success on this front may not be particularly high, the spokesperson said.

GlaxoSmithKline is offering up tech to help others working on vaccines

The British drugmaker isn’t developing its own vaccine, but supporting others’ efforts with its capabilities.

GlaxoSmithKline said on February 3 it would supply some of its technology to aid other vaccine efforts in coordination with the Coalition for Epidemic Preparedness Innovations (CEPI), a group that has been backing efforts to find vaccines.

Read more: A coalition backed by Bill Gates is funding biotechs that are scrambling to develop vaccines for the deadly Wuhan coronavirus

In particular, GSK will offer up its pandemic vaccine adjuvant platform. Adjuvants are added to vaccines to boost immune responses and typically help build a stronger, longer-lasting effect. That also allows for smaller doses to be used per person, making vaccines available to more people, CEPI said.

A small China-based biotech called Clover Biopharmaceuticals announced on February 24 it is using GSK’s adjuvant to supplement its own preclinical coronavirus vaccine. 

Small biotechs say they’re working on vaccines too, but they lack the resources of bigger firms

With more than 500 publicly traded companies, the long tail of the biotech industry has also gotten involved in developing treatments against the coronavirus.

These companies haven’t brought any drugs to market and have significantly limited resources compared with industry-leading pharma and biotech companies, particularly in terms of their ability to run trials in many people or manufacture vaccines or drugs.

In addition to Moderna, CEPI is also working with and awarded funding to vaccine development efforts by Inovio, a small Pennsylvania biotech, and CureVac, a German drug developer also looking at a messenger RNA therapeutic approach.

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