CREDIT: ANGELLODECO / SHUTTERSTOCK
As the novel coronavirus continues to spread across the globe, pharmaceutical giants and smaller biotech companies worldwide are racing to develop effective vaccines and treatments to stem the pandemic. To date, there are no approved vaccines to prevent infections by this coronavirus, or specific drugs to treat them, so speed in development, testing and approval of vaccines and treatments for the disease is critical.
The urgent search for a solution to the coronavirus crisis has companies working on three primary fronts – developing a vaccine to provide immunity to the disease, creating new medicines specifically to treat or prevent coronavirus infections, and repurposing existing drugs to be used as a treatment for patients with COVID-19, the disease caused by the virus.
Companies that are working on experimental vaccines are leveraging a range of innovative technologies, such as DNA, mRNA and adenovirus vector vaccine platforms, that allow for a faster and lower-cost vaccine development process in response to a viral outbreak.
Three of the most promising vaccines are being developed by U.S. biotech firm Moderna, China’s CanSino Biologics, and Johnson & Johnson. CanSino jumped ahead of others in the race to develop a coronavirus vaccine when it announced plans last week to start a Phase 2 clinical trial of its experimental vaccine in China.
The vaccine candidates being developed by Moderna and Johnson & Johnson are among those that have been fast-tracked by the U.S. Department of Health and Human Services (HHS). The Biomedical Advanced Research and Development Authority (BARDA), a division of HHS, will help foot the bill, speed up clinical trials, and provide expertise for the selected companies working with the agency.
Cambridge, MA-based Moderna saw its experimental vaccine enter human trials in record time on March 16, just nine weeks after Chinese authorities released the genetic sequence of SARS-CoV-2, the novel coronavirus. The company, which went public in 2018 in the largest-ever biotech IPO, specializes in an innovative messenger RNA (mRNA) vaccine technology. This approach delivers the virus’s genetic code into the body, which then instructs the cell machinery to create the proteins needed to fight off the virus itself.
Johnson & Johnson, the world's biggest pharmaceutical company, announced that its Janssen unit has identified a lead vaccine candidate utilizing the same technologies used to make its experimental Ebola vaccine. J&J will jointly contribute $1 billion toward its COVID-19 vaccine effort in partnership with the federal government's BARDA, with the goal of supplying one billion vaccine doses worldwide for emergency pandemic use by early 2021.
Companies such as Eli Lilly and Regeneron Pharmaceuticals are working on developing entirely new treatments for COVID-19, while also attempting to repurpose drugs originally designed for other diseases, such as arthritis, malaria and HIV, to treat coronavirus patients. Already approved drugs could provide the fastest path to fighting COVID-19 since doctors already know what are the expected side effects and how safe they are for people, whereas researchers creating new drugs are starting from scratch.
The decades-old generic malaria drug hydroxychloroquine has made headlines in recent weeks for its potential to help with treating COVID-19 based on earlier anecdotal reports from China and France. However, there’s no solid evidence yet that hydroxychloroquine works in treating or preventing the disease. A recent small-scale Brazilian research trial of chloroquine, which is related to hydroxychloroquine, was abruptly halted for safety reasons after putting some COVID-19 patients at a higher risk of potentially fatal heart complications.
In the U.S., a nationwide trial is underway around hydroxychloroquine as a potential therapy for COVID-19. The drug has yet another opportunity to prove its effectiveness against the disease in the World Health Organization’s (WHO) unprecedented large-scale global trial, called Solidarity, which was unveiled last month to test the most promising treatments, including hydroxychloroquine and chloroquine.
When will a coronavirus vaccine or treatments for the disease be ready?
Developing new vaccines and drug treatments takes time and a vast amount of money. Extensive testing in clinical trials is needed to see if new vaccines and drugs are both safe and effective before they can gain regulatory approval.
The vaccine development process has traditionally been measured in years and even decades. But, progress in vaccine development is now occurring at an unprecedented speed, and new technological advances have taken years off the traditional development timeline.
Some experts predict that an approved coronavirus vaccine could be 12 to 18 months away. However, the most promising option for quickly finding a way to manage the COVID-19 global health emergency is repurposing existing drugs, with a number of them now in late-stage clinical trials to test their efficacy for COVID-19.
A number of pharmaceutical giants such as Pfizer and GlaxoSmithKline are teaming up with smaller biotech firms to accelerate development, testing and manufacturing capabilities by providing funding and sharing expertise and technologies. These private company partnerships can be crucial to putting a vaccine or treatment on the market as quickly as possible.
Government agencies and international organizations are also collaborating with companies to tackle the pandemic, including the WHO, BARDA, the National Institute of Allergy and Infectious Diseases (NIAID), and the Coalition for Epidemic Preparedness Innovations (CEPI), an Oslo-based nonprofit founded in 2017 by the governments of Germany, Japan and Norway, the Bill and Melinda Gates Foundation, and others to address a gap in vaccine development funding after the Ebola and Zika virus outbreaks.
One of the largest public-private efforts is being coordinated by CEPI. The organization has invested almost $30 million to date in eight projects and companies, including Moderna, Inovio Pharmaceuticals, and CureVac. All three companies are working on innovative genetic vaccines that are potentially faster to develop than traditional vaccine processing, which requires the laborious production of viral proteins or actual viruses. But, it is still an unproven technology. There are no FDA approved mRNA or DNA vaccines for any disease, so the coronavirus crisis is an opportunity for these technologies to be tested far more quickly than they would have otherwise
“Nature has invented mechanisms to activate our immune system against infectious diseases. With our unique messenger RNA technology, we mimic nature and give our body the information how to fight against the virus,“ said Dr. Mariola Fotin-Mleczek, CureVac’s chief technology officer.
It’s a crowded race with dozens of companies across the globe working on vaccines and drugs, as the coronavirus pandemic continues to ravage the world around us. The number of cases worldwide has passed 2,000,000 and deaths are approaching 130,000, according to John Hopkins University.
The jury is still out on which vaccines and drugs will cross the finish line. While a vaccine is the best way to prevent disease spread since healthy people are protected from becoming infected in the first place, the option that is most likely to save lives in the shortest amount of time is to repurpose existing drugs for other diseases, or develop new drugs to treat and prevent infection.
Here is a list of 26 companies that are working on some of the most talked-about efforts to treat or prevent COVID-19 based on our review of the current research and development efforts. The companies are listed in order of which treatments and vaccines are furthest along in the development pipeline based on the latest information, starting with those in Phase 2/3 clinical trials, followed by Phase 1 clinical trials, and then preclinical development efforts.
Gilead Sciences (Foster City, CA)
Type: Treatment (remdesivir), an antiviral drug
Stage: Several Phase 3 clinical trials started in March. Results are expected in the next few weeks
Additional information: Remdesivir, an antiviral drug that was developed as a drug to treat Ebola and other infectious diseases, is the furthest along of any potential treatment for COVID-19. It is being studied in several large-scale clinical trials in the U.S., U.K., China and other European countries.
Fujifilm Toyama Chemical (Tokyo, Japan)
Type: Treatment (favipiravir), an antiviral drug
Stage: Phase 3 clinical trial started in early April in Japan. On April 9, the company announced a Phase 2 trial in the U.S.
Additional information: Avigan (generic name is favipiravir) was approved in Japan in 2014 as an influenza antiviral drug. Clinical trials of favipiravir in China showed that the drug was effective in treating COVID-19 patients, according to Chinese officials.
Roche (Basel, Switzerland)
Type: Treatment (Actemra), an anti-inflammatory drug
Stage: Phase 3 clinical trials expected to start in April 2020 in different parts of the world, including the U.S.
Additional information: Actemra has been FDA-approved since 2010 to treat various types of arthritis. It also received FDA-approval in 2017 to treat cytokine release syndrome, a life-threatening immune response from certain cancer treatments. Researchers are studying Actemra to see if it could have a similar effect in taming the body’s immune response in severely ill COVID-19 patients. Roche received $25M from BARDA to accelerate its Phase 3 trial.
Sanofi (Paris, France) and Regeneron Pharmaceuticals (Tarrytown, NY)
Type: Treatment (Kevzara), an anti-inflammatory drug
Stage: Phase 2/3 clinical trials started on March 30 in Italy, Spain, Germany, France, Japan, Canada and Russia, and on March 15 in the U.S.
Additional information: Kevzara, the FDA-approved rheumatoid arthritis drug made by Regeneron and Sanofi, could be used to calm an overactive immune response in the lungs seen in severely ill COVID-19 patients. Similar to Roche’s Actemra, Kevzara inhibits a key cytokine called IL-6. In a separate effort, Sanofi has teamed up with Translate Bio on a mRNA vaccine that they hope to have ready for clinical trials by the end of 2020 or early 2021.
Novartis (Basel, Switzerland) and Incyte (Wilmington, DE)
Type: Treatment (Jakafi), an anti-inflammatory drug
Stage: Phase 3 clinical trial initiated on April 2; no start date announced yet
Additional information: Novartis and Incyte are evaluating the use of Jakafi, a JAK inhibitor, to treat a type of severe immune overreaction, called a cytokine storm, that can cause life-threatening respiratory complications in COVID-19 patients. Jakafi is FDA-approved to treat certain bone marrow disorders that that affect your body's ability to produce blood cells.
Mesoblast (Melbourne, Australia)
Type: Treatment (remestemcel-L), an anti-inflammatory treatment
Stage: Phase 2/3 clinical trial initiated; no start date announced yet
Additional information: Mesoblast recently received FDA approval to run a randomized trial with NIIH researchers using its experimental stem cell treatment, remestemcel-L, for patients with acute respiratory distress syndrome due to COVID-19. The theory is that the stem cells could reduce inflammation and strengthen the immune system of COVID-19 patients.
CytoDyn (Vancouver, WA)
Type: Treatment (leronlimab), an anti-inflammatory drug
Stage: Phase 2 clinical trial in the U.S. approved on March 31
Additional information: CytoDyn’s experimental drug, leronlimab, has shown promise as a treatment for patients with a certain type of metastatic breast cancer and HIV. The drug may work to calm the body’s immune response and potential over-response to the virus seen in COVID-19 patients.
Apeiron Biologics (Vienna, Austria)
Type: Treatment (APN01), a dual action recombinant human ACE2
Stage: Phase 2 clinical trials were approved on April 2 to start in Austria, Germany and Denmark
Additional information: Apeiron's drug candidate, APN01, can potentially block the novel coronavirus from entering cells and reduce lung injury, which is one of the most serious complications of COVID-19. It’s previously shown clinical trial success against other lung ailments such as ARDS and pulmonary arterial hypertension.
Eli Lilly (Indianapolis, IN)
Type: Treatments - LY127804, a monoclonal antibody treatment, and baricitinib, an anti-inflammatory drug
Stage: Phase 2 clinical trials expected to start in late April 2020 in the U.S.
Additional information: Eli Lilly is advancing two drugs into clinical trials. Its experimental LY127804 treatment will be tested in COVID-19 patients who are at a higher risk of getting ARDS. Eli Lilly has also partnered with the NIH to study baricitinib, its FDA-approved rheumatoid arthritis drug, as a potential treatment for COVID-19 patients, and will begin its first trial in COVID-19 patients in the U.S. in late April.
CanSino Biologics (Tianjin, China)
Type: Vaccine (Ad5-nCoV), adenovirus vector vaccine
Stage: Phase 2 clinical trial expected to start soon in China
Additional information: CanSino’s vaccine candidate is being developed with China’s Academy of Military Medical Sciences. CanSino said it is moving its vaccine from a Phase 1 to Phase 2 clinical trial after only 3 weeks. Its vaccine uses a common cold virus as a “vector” to deliver the gene for the coronavirus spike protein into cells to trigger an immune response.
Moderna (Cambridge, MA)
Type: Vaccine (mRNA-1273), mRNA vaccine
Stage: Phase I clinical trials started on March 15 in the Seattle and Atlanta in collaboration with the U.S. NIAID
Additional information: Moderna became the first biopharma to start a human trial of an investigational vaccine against COVID-19, setting an industry record of 42 days to move from vaccine design to human testing. BARDA will collaborate with Moderna to prepare for Phase 2 and 3 clinical trials of the vaccine, with the hope of entering Phase 2 trials this spring or early summer.
Inovio Pharmaceuticals (Plymouth Meeting, PA)
Type: Vaccine (INO-4800), DNA vaccine
Stage: Phase 1 clinical trials started on April 6 in the U.S.
Additional information: Inovio approach uses DNA-based technology to activate targeted immune responses that kill virus-infected cells. It has partnered with Beijing Advaccine Biotechnology on the development of its vaccine, and aims to produce one million doses of the vaccine by the end of 2020 for additional clinical trials or emergency use.
BioNTech (Mainz, Germany) and Pfizer (New York, NY)
Type: Vaccine (BNT162), mRNA vaccine
Stage: Preclinical – Phase 1 clinical testing expected to start by late April 2020
Additional information: BioNTech signed a deal with Shanghai-based Fosun Pharmaceutical to co-develop its vaccine candidate BNT162 in China. On March 17, Pfizer announced it had teamed up with BioNTech to co-develop and distribute the vaccine outside of China.
Novavax (Gaithersburg, MD)
Type: Vaccine (NVX-CoV2373), recombinant protein nanoparticle vaccine
Stage: Preclinical – Phase 1 clinical trial expected to start by mid-May in Australia. Results of the trial are expected around July 2020.
Additional information: In preclinical trials, NVX-CoV2373 was able to generate antibodies that could fight off the coronavirus that causes COVID-19. Novavax plans to combine its vaccine candidate with an adjuvant, a substance that enhances the effectiveness of vaccines, to boost immune response in humans.
CureVac (Tübingen, Germany)
Type: Vaccine (mRNA vaccine)
Stage: Preclinical – Phase 1 clinical trials expected to start in June or July 2020 in Europe
Additional information: CureVac, a clinical stage biopharmaceutical company that specializes in mRNA-based drugs vaccines and therapeutics, has selected the best vaccine candidates in preclinical testing and expects to have a vaccine candidate ready for a Phase 1 clinical trial in early summer 2020.
Regeneron Pharmaceuticals (Tarrytown, NY)
Type: Treatment (REGN3048-3051), monoclonal antibody treatment
Stage: Preclinical – Phase 1 clinical testing expected to start by the end of August 2020
Additional information: Regeneron said in March that it’s identified hundreds of virus-neutralizing antibodies from its genetically engineered mice and patients who have recovered from Covid-19, and will choose the best two with which to create a 'cocktail' treatment. The company used the same technology to develop a drug for the Ebola virus, which is under review by the FDA.
Vir Biotechnology (San Francisco, CA) and GlaxoSmithKline (London, UK)
Type: Treatment ((VIR-7831 and VIR-7832), monoclonal antibody treatment
Stage: Preclinical – Phase 1 clinical trials expected to start in July – Sept. 2020
Additional information: Vir said two of its antibody drugs appear to be effective against the COVID-19. GSK announced on April 6 that it’s investing $250M in Vir and will collaborate on the development of potential antibody treatments for COVID-19. Vir has also partnered with Biogen, Chinese biotech company WuXi Biologics, and Alnylam Pharmaceuticals on coronavirus treatments.
Emergent BioSolutions (Gaithersburg, MD)
Type: Treatment (plasma-based treatment)
Stage: Preclinical – Phase 1 clinical trials expected to start this summer
Additional information: Emergent announced on March 11 that it’s working on two different plasma-based treatments (one using horse plasma and the other human plasma) using antibodies from recovered COVID-19 patients. The company announced on April 3 that it received $14.5M in federal funding from BARDA to speed the development of its treatment candidates.
Johnson & Johnson (New Brunswick, NJ)
Type: Vaccine (adenovirus vector vaccine)
Stage: Preclinical – Phase 1 clinical trial expected to start by Sept. 2020 at the latest
Additional information: J&J’s subsidiary, Janssen Pharmaceutica, began developing its vaccine in February with BARDA support using the same vaccine platform used to develop its experimental vaccine for Ebola. On March 30, J&J announced a lead vaccine candidate. Its goal is to provide a global supply of more than one billion doses of its vaccine, with the first batches available for emergency use in early 2021. J&J said it’s committed to providing an affordable vaccine to the public on a not-for-profit basis.
Pfizer (New York, NY)
Type: Treatment (Protease inhibitor antiviral drug)
Stage: Preclinical – Phase 1 clinical trial expected to start as early as August
Additional information: Pfizer announced on April 9 that it identified a lead coronavirus drug candidate, which research shows blocks the new corona virus from replicating. The findings so far indicate that the drug candidate could slow or stop the spread of the virus in COVID-19 patients with mild to moderate symptoms.
Vaxart (San Francisco, CA)
Type: Vaccine (oral recombinant vaccine)
Stage: Preclinical - Phase 1 clinical trial expected to start early in the second half of 2020
Additional information: Vaxart is developing an oral recombinant vaccine that’s given by tablet rather than by injection. On March 31, Vaxart said it has produced five COVID-19 vaccine candidates for testing in its preclinical models, and expects to advance the best performing vaccine to manufacturing for clinical trials.
Clover Biopharmaceuticals (Chengdu, China) and GlaxoSmithKline (London, UK)
Type: Vaccine (COVID-19 S-Trimer), recombinant protein subunit vaccine
Stage: Preclinical – data from collaborations over the next few months will be used to determine the next steps for clinical development of a vaccine candidate
Additional information: GSK announced a partnership on Feb. 24 with Chinese biotech firm Clover Biopharmaceuticals to combine GSK’s adjuvants with Clover’s protein-based COVID-19 vaccine candidate. Clover has also partnered with Berkeley, CA-based Dynavax Technologies in March to use Dynavax’s proprietary adjuvants to support development of Clover’s vaccine.
Amgen (Thousand Oaks, CA) and Adaptive Biotechnologies (Seattle, WA)
Type: Treatment (antibodies from recovered COVID-19 patients)
Additional information: The companies announced a partnership on April 2 to develop a therapeutic to prevent or treat COVID-19 on an accelerated basis. Adaptive will use its platform to screen blood samples from recovered COVID-19 patients to identity the specific antibodies that neutralize the novel coronavirus.
Sources: The Wall Street Journal, The New York Times, The Washington Post, Bloomberg News, Stat News, Clinical Trials Arena, PhRMA, FiercePharma, FierceBiotech, Science, BioSpace, Contract Pharma and company press releases.
All data and statistics are based on publicly available sources as of April 12, 2020. Due to the unprecedented and rapidly changing nature of the coronavirus pandemic, some information may be out of date.