Health and Healthcare

As CDC Issues Notice, Stock Market Bets Which Company Gets First COVID-19 Vaccine FDA Approval

Jon C. Ogg

Published: September 2, 2020 7:27 pm

America and the rest of the world is getting ready for a vaccine that will help protect public health against the COVID-19 pandemic. The societal impact of the coronavirus has changed many lives, and it has led to more than 6 million cases and over 184,000 deaths in the United States alone. The coronavirus has wrecked the economy, led to millions of layoffs and furloughs, closing down countless businesses and impacted millions of Americans paychecks who are still working. If a vaccine is approved the economic impact will be countable in the trillions of dollars.

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While 24/7 Wall St. has been tracking the COVID-19 outbreak with its own maps and its own data for months, the stock market surged again on Wednesday and the S&P 500 and NASDAQ both hit new all-time highs. There are many issues which drive stocks higher, and the stock market has been lining up bets that a COVID-19 vaccine is going to arrive. The question is now becoming to “When” rather than “If” a vaccine gets approved.

Multiple biotechnology and pharmaceutical corporations are seeking fortunes to get a vaccine and treatment out to win the war against COVID-19. As of this week, there are now three companies leading the fight with vaccine studies in Phase III trials. News on Wednesday was out that the Center for Disease Control and Prevention (CDC) has notified public health officials in all 50 states to prepare to distribute a coronavirus vaccine as soon as late in October or at the start of November.

As a result of this news and based on three studies having entered late-stages, the stock market is making bets on which of the vaccine leaders is going to get approval first. First and foremost, there is no assurance at all that an the U.S. Food & Drug Administration (FDA) is going to approve any of these three vaccine candidates. There are also no assurances that these three Phase 3 trials are going to be a success. And one more consideration is that the CDC’s first distribution appears to be targeting healthcare workers and high-risk groups first.

All three of the furthest-along vaccine candidates appear to have some serious benefits in creating antibodies to help prevent COVID-19. There are also many debates and many differing opinions about how effective and how safe these vaccines will actually be. And while it may be weeks or months before approval can be awarded, it could take even longer before availability is widespread.

It is far too early to make any predictions about which of the Phase 3 trials will win approval first, and again IF they get approval at all, but the stock market’s bets as of Wednesday seem to be favoring the Phase 3 from Moderna, Inc. (NASDAQ: MRNA) and the Phase 3 under Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) over the newly-started Phase 3 under AstraZeneca PLC (NYSE: AZN). Making this statement is absolutely not meant to be a prediction at all, but it’s an observation of the known data today.

And here is how the stock market bench-marked its bets on Wednesday. There was a 0.94% gain on AstraZeneca’s ADSs to $55.90, still down from a 52-week high of $64.94. Shares of Moderna closed up 2.2% at $64.72. BioNTech’s share price rose 7.2% to $61.99 and Pfizer’s stock rose by about 0.9% to $37.20. Pfizer’s market cap is the largest of the lot at $206 billion, followed by AstraZeneca’s ADSs valued at about $150 billion. BioNTech is valued at close to $14.7 billion and it has only been listed in the U.S. since October of 2019, and Moderna has a $25.5 billion value and has been public only since the end of 2018.

It is also urgent for investors to consider that other public companies are still in the running, and it’s widely expected that the global market has room for multiple COVID-19 vaccines. There may also be a need for the public to be vaccinated more than once, and it’s very possible that there could be a recommendation that multiple vaccines taking different tracks to prevent or treat COVID-19 will be needed.

As a reminder, the FDA has laid out that it will not approve a COVID-19 vaccine or treatment if it is not proven to be effective, but the FDA has also laid out the path that could lead to an even more rapid approval if the data make it approvable. China and Russia have already indicated that they would begin their vaccines ahead of the traditional approval process.

Here is how the data stacked up as of this week for each company.

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.

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 front-runner 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.

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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.

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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.

Pfizer and BioNTech already announced in July that they have a pre-order for their vaccine for nearly $2 billion. Their Phase 3 trial started in late July as well.

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.

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 competition very soon. 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. Shares of J&J rose by 1.5% to $153.83 on Wednesday.

Another company in the hunt to supply COVID-19 vaccines is Novavax Inc. (NASDAQ: NVAX). While its stock was down 2% at $102.90 in Wednesday’s trading, the stock was higher in the after-hours after it published additional positive Phase 1 study data. Novavax 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.