Health and Healthcare

3 COVID-19 Vaccine Trials Are Now in Phase 3, With More on the Way

Jon C. Ogg

Published: September 1, 2020 8:46 am

The societal impact of the coronavirus that sparked the COVID-19 pandemic has been a society-changing event. The world went from the longest economic expansion on record to the fastest recession and fastest bear market of our lives. Due to illness and death, families, workplaces, retail and all forms of entertainment have greatly changed. They have not changed for the better. Hope may be closer than ever.

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24/7 Wall St. has been tracking the COVID-19 outbreak with its own maps and its own data for months, but there is also an angle of the business side of this equation. Multiple biotechnology and pharmaceutical corporations are seeking their stake in treating COVID-19. Many advancements now have happened around various aspects of testing for active COVID-19 and for the antibodies. The real victory that awaits is for those companies that can develop a successful vaccine or a follow-on treatment that will cure patients or greatly minimize the impact of COVID-19.

Where the best news, outside of an outright success and approval by the U.S. Food and Drug Administration (FDA), stands right now is that there are three U.S. vaccine trials in Phase 3 studies. All three appear to have some serious benefits, but none are approved yet, and it may be weeks to months before approval and availability. That’s assuming these vaccine candidates perform better in larger studies.

AstraZeneca

AstraZeneca PLC (NYSE: AZN) announced late on Monday that it has begun enrolling up to 30,000 people who are 18 years old and older across approximately 100 trial centers inside and outside of the United States with its AZD1222 specifically for the prevention of COVID-19. The company has said that AZD1222’s advancement has been supported by safety and immunogenicity across all adult age groups and this U.S. trial funded by the Biomedical Advanced Development Authority (BARDA) under the U.S. Department of Health and Human Services and the National Institutes of Health.

While led by AstraZeneca, AZD1222 was co-invented by the University of Oxford and a spinout company called Vaccitech. The treatment is said to use a chimpanzee viral vector based on a weakened version of a common cold and also contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, and according to the most recent release, a surface spike protein is produced and this sets the immune system to attack the SARS-CoV-2 virus if it later infects the body.

As for the great hope prior to AstraZeneca advancing this into Phase 3, it was back in July of this year that the publication The Lancet posted data from interim results from an ongoing Phase 1/2 trial showing that AZD1222 was tolerated and that it generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants. In May of 2020, AstraZeneca received more than $1 billion in support from BARDA to advance this vaccine, and the current Phase 3 study is part of that BARDA funding agreement.

Again, the big issue now is whether these results show the same tolerability and efficacy in larger groups. AstraZeneca is not alone in its quest to defeat COVID-19, as two additional Phase 3 vaccines are underway that also have government funding.

Moderna Inc. (NASDAQ: MRNA) recently announced that its COVID-19 vaccine candidate (mRNA-1273) is showing signs of working and inducing an immune response in adults aged 56 and older at similar rates to in younger patients. Moderna is one of five biotech or pharmaceutical stocks that have been selected under Operation Warp Speed to develop a COVID-19 vaccine, and its existing Phase 3 clinical trial is being analyzed for its efficacy to prevent infection of COVID-19. The U.S. government recently gave an order, subject to the vaccine being approved of course, to purchase 100 million initial doses of the vaccine candidate for a sum of up to $1.525 billion.

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Moderna’s stock has been the subject of many analyst reports calling for substantial upside, but a recent patent ruling within the United States went in favor of Arbutus Biopharma Corp. (NASDAQ: ABUS), which may have implications for Moderna’s coronavirus vaccine frontrunner status. The U.S. Patent Trademark Office ultimately rejected arguments made by Moderna that an Arbutus patent should be revoked because it described obvious concepts. This patent relates to lipid nanoparticle technology that allows the human body to make its own therapeutic proteins.

Pfizer

The next Phase 3 COVID-19 study comes from Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX). A recent update showed that their mutual vaccine candidate was well tolerated and it is on track for regulatory review as early as October. If those targets are hit, the two companies have plans to supply up to 100 million does worldwide by the end of 2020 and roughly 1.3 billion does by the end of 2021.

Pfizer and BioNTech previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, as compared to the BNT162b1 candidate.

And Others

What investors have been looking forward to is at least one vaccine. That said, it has been widely reported that one vaccine is deemed to be not enough to control the pandemic adequately. It is very possible that true vaccination might not be 100% effective in prevention, similar to a flu shot even when the powers that be get their strain predictions right that year. It is also possible that more than one of the vaccines prove to be far more effective in treating COVID-19 over time.

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The three studies that are in Phase 3 also will have some continued interest. Johnson & Johnson (NYSE: JNJ) is said to be kicking off its own trial, which could be more than 60,000 patients globally as soon as late September. The company began its first human study of its Ad26. COV2. S vaccine back in July in the United States and Belgium.

Another company in the hunt to supply COVID-19 vaccines is Novavax Inc. (NASDAQ: NVAX). It recently announced that it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of its NVX-CoV2373 COVID-19 vaccine. That candidate is currently under an advance purchase agreement, but Novavax has this in multiple Phase 2 clinical trials and it is not scheduled for delivery until as early as the second quarter of 2021. This purchase arrangement also will be subject to licensing of the Novavax vaccine by Health Canada.

These are far from the only COVID-19 vaccine candidates being studied. 24/7 Wall St. also has featured other companies that are in the hunt for the cure, but those stages of studies can change rapidly.

One thing is certain. The financial markets are expecting at least one of these vaccine candidates to be effective enough for FDA approval. The stock market at all-time highs, with unemployment still at 10% or higher and with valuations looking rather stretched, just becomes much harder to rationalize if the economy of 2020 is going to be stuck in the same mud for another year or two.