3 Leaders in the Race for a COVID-19 Vaccine

With more than 20 million cases of the coronavirus worldwide, the question isn’t if there will be a vaccine; it’s when will the vaccine be available—and who will be the first to market.

It appears that Russia may actually have a leg up on the competition. You may have heard that Russia recently approved the world’s first COVID-19 vaccine. And, in a nod to Russia’s surprise launch of the world’s first satellite, the vaccine has been dubbed Sputnik-V.[1]

Interestingly though, the vaccine hasn’t been tested in Phase-3 clinical trials. Here in the U.S., Phase-3 trials are the final trial before a biotech or biopharmaceutical company can seek FDA approval, as a Phase-3 trial scientifically measures a drug’s effectiveness and safety in thousands of patients.

So, there are many questioning Russia’s vaccine… might it be more aptly dubbed the Kursk II?

It’s more likely that the first FDA-approved COVID-19 vaccine will come from one of three, now well-known biotechs: Moderna, Inc. (MRNA), Pfizer, Inc. (PFE) or Novavax, Inc. (NVAX). All three companies are participating in the U.S.’s Operation Warp Speed, which is funneling billions of dollars into research and clinical trials for a COVID-19 vaccine. The goal of the program is to provide 300 million doses of the vaccine by January 2021.

Will the U.S. be able to reach this goal? Considering that Moderna, Pfizer and Novavax have all started or are on the verge of starting Phase-3 clinical trials with their vaccine candidates, we’re cautiously optimistic that a COVID-19 vaccine could be available in the near future. To be honest, we’ve seen a lot of drugs with promise fail Phase-3 trials over the years, however. It’s really impossible to have an informed opinion (even the researchers developing the drug don’t know for certain), but what one can always have is hope.

Moderna appears to be the frontrunner right now. The company’s Phase-1 trials ignited an immune response with normal side effects. Think headaches, achiness, fatigue and chills. Moderna then initiated a Phase-3 trial of its vaccine candidate in early August. The trial includes 30,000 adult patients who will participate at 89 clinical research sites in the U.S.

At the moment, Pfizer’s COVID-19 vaccine candidate is neck-in-neck with Moderna’s candidate. In a collaboration with BioNTech SE (BNTX), Pfizer entered into a Phase-2/3 trial in early August. Its vaccine candidate is being tested at 120 sites around the world. Early clinical trial results saw an immune response with “mild to moderate” side effects.

Pfizer and BioNTech are hoping to receive emergency authorization from the FDA in October, which would ensure that the vaccine would be available later this year.

Novavax is trailing Moderna and Pfizer, as the company expects to start Phase-3 clinical trials in September. Recent data from the company’s Phase-1 trial showed high levels of antibodies and an immune response. Side effects were slightly more severe but only lasted about two days.[2]

Clearly, it’s a tight race for a COVID-19 vaccine, and Moderna, Pfizer, and Novavax aren’t the only runners in the race. Sanofi (SNY) is partnering with GlaxoSmithKline (GSK), and the two will start a Phase-1/2 trial in September. Johnson & Johnson’s (JNJ) subsidiary, Jansen Research & Development, expects to start a Phase-3 trial in late 2020. And AstraZeneca (AZN) is collaborating with Oxford University, with its vaccine candidate expected to begin Phase-3 trials in September.[3]

At the moment, it’s anyone’s guess who will cross the finish line first. But, based on early clinical trial data and the start of several Phase-3 trials, current hope is that a vaccine could be available later this year or early next year.

In the meantime, there are also more than 550 drugs in development programs to determine if they are potential treatments for COVID-19.[4] One such treatment has received emergency use authorization (EUA) from the FDA.

Back in May, the FDA authorized Gilead Sciences, Inc. (GILD) to use its antiviral remdesivir for the treatment of patients with severe COVID-19. Remdesivir is still an investigational drug, and it is also in clinical trials to determine its optimal treatment duration. Gilead donated 1.5 million doses of the treatment, or about 140,000 treatment regimens.[5]

Just this week, Gilead submitted a New Drug Application (NDA) to the FDA for remdesivir under the brand name Veklury. The application comes on the heels of positive Phase-3 clinical studies where Veklury was well-tolerated and led to clinical improvement in patients.[6]

Under the FDA’s Coronavirus Treatment Acceleration Program (CTAP), there haven’t been any medications approved for the treatment of COVID-19 yet. Gilead’s Veklury is the frontrunner in the race for viable treatment options right now, and we should know soon if it receives FDA approval.

Overall, there are certainly positive developments happening in the race for a COVID-19 vaccine and treatments. Until we have more clarity on the best ways to combat the disease, we continue our cautious stance in the management of all of our portfolios.

If you would like to learn more, please give me a call.

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[1] https://www.cnn.com/2020/08/11/europe/russia-coronavirus-vaccine-putin-intl/index.html

[2] https://www.cnn.com/2020/08/06/health/covid-19-vaccines-explainer/index.html

[3] https://www.usatoday.com/story/news/health/2020/08/08/feds-spending-more-than-9-billion-covid-19-vaccine-candidates/5575206002/

[4] https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap

[5] https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19

[6] https://www.gilead.com/news-and-press/press-room/press-releases/2020/8/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-veklury-remdesivir-for-the-treatment-of-covid19