Data source: Yahoo! Finance.

Big losses in the vaccine area

Opportunity abounds

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post With COVID-19 variant threats rising, why are vaccine stocks falling? appeared first on The Motley Fool Australia.

What happened

Shares of coronavirus vaccine maker Novavax (NASDAQ: NVAX) tanked by 37.7% in May, according to data provided by S&P Global Market Intelligence. The collapse was a result of the company's repeated delays with the manufacturing of its coronavirus vaccine as well as its announcement that it won't file for the candidate's regulatory approval before the third quarter.

So what

The combination of delays with regulatory filings and manufacturing delays means that Novavax won't be able to deliver its contractually obligated doses to the European Union before 2022. In short, certain raw materials needed for the vaccine are in scant supply. Furthermore, the company will be even further behind other vaccine makers like Pfizer and Moderna, which are already on the market and in wide distribution.

In the long run, however, these issues probably won't harm the company's revenue making potential. Even amid the delays, Novavax is still signing new sales agreements with groups like the Gavi Vaccine Alliance, which agreed to buy 350 million doses of its vaccine on May 6. Likewise, Novavax still has commitments to make more than 1.1 billion doses in conjunction with its manufacturing collaborators. So, while May's losses might be frustrating, they probably don't reflect much genuine destruction of shareholder value. It's likely that the stock will rebound once sales revenue starts to be reflected in earnings reports.

Now what

While investors are unlikely to have much patience for further delays, Novavax is still proceeding with its plans to commercialize its coronavirus vaccine globally, and it will almost certainly continue to succeed in doing so. Notably, in early May it also reported that its candidate is effective against at least one viral variant, which should keep it competitive with the currently marketed vaccines. But shareholders will need to wait a bit longer before the full impact of the revenue is reflected in the company's quarterly earnings reports.

Beyond that, the company is also pursuing its combination vaccine project, which could inoculate people against both influenza and the coronavirus in a single jab. On May 10, it published preliminary evidence from preclinical studies that suggests the combination vaccine could be effective.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

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Novavax Inc (NASDAQ: NVAX) shares gained more than 2,600% last year as the clinical-stage biotech became one of the front-runners in the race to develop a coronavirus vaccine -- and was awarded $1.6 billion from the United States Government to support its efforts.

That was a genuinely amazing performance, and as 2021 begins, Novavax still has a lot on its agenda. Here are three things investors should be looking for from the company this year.

1. A possible coronavirus vaccine -- and revenue

Novavax has a late-stage clinical trial for its coronavirus vaccine candidate, NVX-CoV2373, well underway in the United Kingdom, and could be ready to report interim data from it early in the current quarter. If that data is positive, the company will use it to support its submissions to various major healthcare regulators.

Regulatory agencies granted emergency use authorizations for the COVID-19 vaccines of Pfizer Inc (NYSE: PFE) and Moderna Inc (NASDAQ: MRNA) within weeks of their phase 3 interim reports. If Novavax's fortunes are similar, the company could begin generating vaccine revenue in the first half of 2021. NVX-CoV2373 would be its first marketed product -- a huge step for the company.

2. A NanoFlu regulatory submission

Last spring, Novavax reported that its flu vaccine candidate met all primary endpoints in a pivotal trial. Later in the year, the company assembled a team of experts to shepherd NanoFlu through the regulatory approval process.

Novavax hasn't said when it will submit its application for NanoFlu to the Food and Drug Administration. But it did say it would apply to have that vaccine reviewed under the FDA's accelerated approval pathway. It's possible a submission could happen at some point this year.

3. Progress on a combined coronavirus/flu vaccine

In October, Novavax said it would begin exploring the possibility of producing a single shot that combines both its coronavirus and flu vaccines. The company said any such dual-purpose product would be for post-pandemic use. Novavax didn't provide other timeline details. But we could imagine that it may report preclinical data or other early details on this project this year.

Positive results on any of the fronts listed above could provide a catalyst for Novavax's shares. So even though its 2020 stock price gain was massive, there's room for additional good news to drive this biotech company even higher.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

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Sure, 2020 will forever be known as the year of the COVID-19 pandemic. But 2021 just might be memorialized as the year the pandemic was defeated. Two COVID-19 vaccines have already received emergency use authorization (EUA) in the United States with a third vaccine also authorized in the United Kingdom.

The big stories in the new year, though, could come from vaccines that haven't made it to market yet. It's possible that the stocks of the companies developing these experimental vaccines will deliver tremendous gains over the next 12 months. Here are three coronavirus stocks that are especially poised to soar in 2021.

1. Novavax

Novavax Inc (NASDAQ: NVAX) ranked as the top-performing coronavirus stock of 2020 with a staggering gain of close to 3,000%. Can the biotech stock deliver another sizzling performance this year? Don't be surprised if it happens.

The company expects to report results from a late-stage study of COVID-19 vaccine candidate NVX-CoV2373 conducted in the UK in early 2021. Novavax initiated another late-stage study in the US and Mexico last week. Look for results from this study sometime in the second quarter. 

If all goes well with these studies, billions of dollars will pour into Novavax's coffers. The company has deals in place with several countries (including the US, UK, Australia, Canada, and New Zealand) to supply close to 300 million doses of NVX-CoV2373. 

This cash influx will help Novavax further explore the development of a COVID-19/flu combo vaccine. The biotech already has a promising flu vaccine candidate called NanoFlu that's on track for regulatory submissions. 

2. Vaxart

Vaxart Inc (NASDAQ: VXRT) trailed behind only Novavax to become the No. 2 coronavirus stock of last year. It generated a sizzling return of around 1,600%. At one point in 2020, Vaxart's shares were up more than 4,700% year to date. I think the stock could have a lot more room to run in 2021.

The company is currently evaluating its COVID-19 vaccine candidate VXA-CoV2-1 in a phase 1 clinical study. Results from the study are expected this month. Vaxart hopes to quickly advance its experimental vaccine into phase 2 testing if the phase 1 results are positive.

VXA-CoV2-1 stands out from the leading coronavirus vaccines. It's a single-dose tablet instead of an injection. That makes Vaxart's vaccine more convenient to take and to distribute and store. The experimental vaccine also appears to promote mucosal immunity (immune system responses that occur in mucosal membranes in the eyes, nose, and elsewhere). 

Despite its impressive performance last year, Vaxart's market capitalisation remains below $700 million. With the advantages offered by VXA-CoV2-1, the biotech will be worth a lot more than that if its clinical studies of the COVID-19 vaccine candidate go well.

3. Altimmune

Altimmune Inc (NASDAQ: ALT) finished 2020 with its shares up close to 500%. By late July, the stock has soared more than 1,600% year to date. It's possible that Altimmune could regain those highs this year.

The biotech's COVID-19 vaccine candidate AdCOVID shares several things in common with Vaxart's experimental vaccine. It only requires a single dose. It can be stored at room temperature for extended periods. And it appears to provide mucosal immunity. The major twist is that AdCOVID is an intranasal vaccine.

There's one glaring problem for Altimmune right now, though. The US Food and Drug Administration (FDA) placed a clinical hold on a planned early stage clinical study of AdCOVID because it wants changes to the study's protocols and additional manufacturing data.

I suspect that Altimmune will be able to quickly address the FDA's concerns and move forward with its study of AdCOVID. The company even stated that it doesn't expect the clinical hold will significantly change its overall timeline for the development of the vaccine. If AdCOVID delivers on its potential, Altimmune could be an under-the-radar COVID vaccine stock that skyrockets in 2021.

Remember the risks

Keep in mind that all three of these stocks are very risky. While their experimental COVID-19 vaccines look promising right now, there's always a chance that they'll disappoint in clinical testing. Novavax, Vaxart, and Altimmune are poised to soar in 2021, but they could easily sink instead. 

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

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Since the beginning of the COVID-19 pandemic, high hopes have been placed on the potential for a vaccine. The U.S. government established Operation Warp Speed, a program with the goal of accelerating the development of safe and effective novel coronavirus vaccines. Biopharmaceutical companies both large and small shifted resources to focus on COVID-19 vaccine research.

Today, these efforts are closer to paying off than ever before. But what's the real state of the coronavirus vaccine race? Here are seven key things you'll want to know.

1. Who the leaders are right now

There are currently 180 COVID-19 vaccine programs in development, according to the World Health Organization (WHO). Thirty-five of those vaccine candidates are being evaluated in clinical studies with the rest in preclinical testing. Nine of the 35 clinical-stage COVID-19 vaccine candidates are in late-stage testing.

Chinese drugmakers Cansino Biologics, Sinopharm, and Sinovac Biotech are developing four of the late-stage coronavirus vaccine candidates. Russia is already allowing a COVID-19 vaccine developed by Moscow's Gamaleya Research Institute of Epidemiology and Microbiology to be administered to some individuals, although the vaccine is still in late-state testing.

There are 4 late-stage COVID-19 vaccine candidates targeting the U.S. market:

• Pfizer (NYSE: PFE) partnered with BioNTech (NASDAQ: BNTX) to develop BNT162b2, a vaccine that uses modified messenger RNA (mRNA) to spur the body to produce antibodies to the novel coronavirus SARS-CoV-2.
• Moderna (NASDAQ: MRNA) is also developing an mRNA vaccine candidate, mRNA-1273. 
• AstraZeneca (NYSE: AZN) teamed up with the University of Oxford to develop AZD1222, which delivers genetic material from the SARS-CoV-2 spike protein using a weakened version of the adenovirus (a common cold virus).
• Johnson & Johnson (NYSE: JNJ) is starting its late-stage testing of Ad26.COV2.S this month.

2. When a vaccine will likely be available

There's no way to be completely sure when a COVID-19 vaccine will be available. It's possible that problems could arise in clinical studies. For example, AstraZeneca recently paused its late-stage clinical trial of AZD1222 due to a serious adverse reaction in a participant.

However, the chances appear to be reasonably good that a coronavirus vaccine will receive FDA emergency use authorization (EUA) before the end of 2020. Pfizer and BioNTech expect to seek authorization for BNT162b2 in October if late-stage testing goes well. AstraZeneca and Moderna might not lag too far behind.

It's possible that there will be a phased roll-out of early COVID-19 vaccines. One potential scenario would be for healthcare workers and high-risk individuals to receive the vaccine first, followed by the rest of the population.

3. How safe and effective the vaccines will be

We won't know how safe and effective individual COVID-19 vaccines will be until they've completed late-stage testing. However, to secure an EUA the FDA must determine that the benefits of the vaccine outweigh the risks. The agency has stated that it will review "the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product" before granting an EUA. 

To win full FDA approval, a COVID-19 vaccine will have to demonstrate at least 50% efficacy in a placebo-controlled clinical study. It will also need to meet the general safety requirements for previously approved vaccines for infectious diseases. 

4. How many doses will be required

Most of the coronavirus vaccines in late-stage testing require two doses, typically administered four weeks apart. Johnson & Johnson's investigational COVID-19 vaccine, however, requires only one dose.

5. How much a coronavirus vaccine will cost

Coronavirus vaccines will be provided to all Americans at no cost. Healthcare providers, though, could charge insurers for the cost of administering the vaccines.

6. Which vaccines could be in the second wave

Three COVID-19 vaccines are currently in phase 2 clinical testing, according to the WHO. These include vaccines developed by Novavax (NASDAQ: NVAX), German biotech CureVac (NASDAQ: CVAC), and Chinese drugmaker Anhui Zhifei Longcom. Inovio Pharmaceuticals (NASDAQ: INO) is awaiting FDA approval to begin phase 2 testing of its coronavirus vaccine candidate as well.

7. Which stocks are poised to win the most

Any of the stocks of companies that win FDA EUA or approval for their respective COVID-19 vaccines will likely perform well. However, the smaller biotech stocks would almost certainly enjoy bigger gains than the big pharma stocks. This could mean that BioNTech and Moderna could be the biggest winners among the leaders in the coronavirus vaccine race.

Keep in mind, though, that there's still a risk that the vaccine candidates will stumble in clinical testing. The safer stocks to buy, therefore, will be those of large drugmakers such as AstraZeneca and Pfizer since the companies have enough product diversification to withstand a setback in their COVID-19 vaccine programs.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

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One or more drugmakers with COVID-19 vaccines in development could make a fortune very soon. The global market for vaccines against the novel coronavirus could reach $20 billion next year.

When companies make fortunes, their investors can too. How should you invest in coronavirus vaccine stocks? Here are three simple steps to take.

1. Determine your risk tolerance

You want to make as much money from your investment as possible, but there's a key principle to be aware of with investing: To achieve higher returns, you must accept a higher level of risk. Before investing in coronavirus vaccine stocks, determine what your risk tolerance is.

Every stock has risks, but the ones you'll have to buy to profit from a coronavirus vaccine come with more uncertainty than most. That's especially true for small biotechs with no approved products on the market yet. Any setback can cause these biotech stocks to plunge.

The earlier a given drugmaker's pipeline candidates are in the clinical development process, the riskier its stock. For example, a COVID-19 vaccine candidate that's in preclinical testing has a much higher chance of failure than one that has sailed through to late-stage clinical testing in humans. Also, the more pipeline candidates that a company has, the less risky it tends to be. 

Buying shares of large pharmaceutical companies presents a lower risk level. These drugmakers already have multiple approved products on the market and generate significant revenue. Many of them are quite profitable. Although a stumble for their COVID-19 vaccine candidates would cause their shares to fall, it probably wouldn't result in the stock crashing. 

2. Identify stocks that fit your investing style

Once you've objectively assessed how much risk you're willing to take on, the next step is to identify the stocks that best fit your investing style. Below are some ideas based on three risk-tolerance levels.

Lower risk tolerance

The following three big pharma stocks are developing COVID-19 vaccine candidates and are worthy of consideration by investors with low risk tolerance levels:

Data sources: Yahoo! Finance and company press releases. Market caps as of Sept. 3, 2020.

Pfizer is developing COVID-19 vaccine candidate BNT162b2 with its partner, BioNTech. The companies expect to seek emergency-use authorisation for the vaccine from the Food and Drug Administration in October 2020.

More risk tolerance

The following drugmaker stocks have at least one pipeline candidate in late-stage testing (lowering their risk), but don't yet have approved products on the market (increasing their risk):

Data sources: Yahoo! Finance and company press releases. Market caps as of Sept. 3, 2020.

Among these three biotechs, Moderna has raked in the most external funding for its COVID-19 vaccine candidate, including up to $2.48 billion from the US government.   

Highest risk tolerance

Here are two clinical-stage biotech stocks with no late-stage programs that only investors with the highest risk tolerance might consider:

Data sources: Yahoo! Finance and company press releases. Market caps as of Sept. 3, 2020.

Vaxart has one of the most intriguing COVID-19 vaccine candidates because it is administered in tablet form, rather than via injection.

3. Evaluate the companies' other opportunities and challenges

Finally, make sure you check out other business opportunities and challenges for any coronavirus vaccine stock you're considering. For example, all of the companies mentioned have other pipeline candidates.

You might find that there could be compelling reasons to think about buying a stock even if its COVID-19 vaccine flops. AstraZeneca is a case in point. The big drugmaker claims several blockbuster franchises with strong growth prospects, plus a pipeline loaded with potential winners.

Buy and watch

Once you've completed these three steps, you're ready to invest. Keep in mind, though, that coronavirus vaccine stocks require monitoring. Their prospects change frequently with clinical study results and news of government reimbursements. Some might very well prove to be stocks you can buy and hold for years, but you need to watch them closely.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

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This data comes from Commonwealth Bank of Australia (ASX: CBA)'s CommSec platform, which is the most widely used broker in Australia. As such, I think it gives us a pretty good idea of what the broader trends are. So without further ado, here are the top US shares Aussies were trading last week (10–14 August).

Most popular US shares:

1) Tesla Inc. (NASDAQ: TSLA)

You just can't keep Elon Musk's baby in a corner. Tesla, an electric car and battery manufacturer, was once again in the spotlight last week. A likely catalyst for this renewed interest was the company announcing a 5-for-1 stock split, which will see the price of Tesla shares cut 5 ways when it goes through later this month. Seeing as one Tesla share will set an Aussie investor back around $2,540 today (US$1,835), the move to split the shares was evidently welcomed. This company's share price is now up 327%, year to date. Next stop, Mars?

2) Apple Inc. (NASDAQ: AAPL)

Apple is our second most popular US stock for Aussies this week and I'm sensing a theme here. Apple is another company that has just announced an August stock split — this time 4-for-1. It won't have the dramatic results of the Tesla share split, seeing as Apple shares were most recently trading for US$458. Still, it wasn't getting in the way of Aussies picking up shares of the iPhone maker last week.

3) Microsoft Corporation (NASDAQ: MSFT)

No stock split news from Microsoft last week, but that didn't stop Australian investors giving this giant the bronze medal. Microsoft has been high in demand this year, despite its gargantuan market capitalisation (currently US$1.59 trillion). Microsoft has several facets that are deemed to be 'pandemic proof', such as its Xbox gaming division and successful remote working software Teams. It's traditional products like Office and Windows are also remarkably resilient and give this company a massive stream of recurring revenue. No wonder Aussies are keen to have this giant in their portfolios.

4) Nio Inc. (NYSE: NIO)

Nio is actually a Chinese company that is only listed on the New York Stock Exchange as an ADR (American Depositary Receipt). Even so, it hasn't stopped Aussies from wanting a slice of this Tesla rival. Nio is China's answer to Tesla and is striving to showcase a growing portfolio of electric vehicles of its own. It's been a bit of a rollercoaster for Nio shareholders over the past year, with Nio shares fluctuating between US$1.19 and US$16.44 at various points. Talk about a bumpy road!

5) Novavax Inc. (NASDAQ: NVAX)

Our final US share this week is this Maryland-based vaccine manufacturer. Looking at this company's share price over 2020 so far is enough to give you a headache – Novavax shares are up more than 3,500% since the start of 2020. Speculation that this company will play a large role in the rollout of a coronavirus vaccine seems to be behind the optimism for this company. Hopefully, it comes to pass — otherwise, it's Novavax investors who might end up getting a jab.

The post Here are the top 5 US shares ASX investors have been buying appeared first on The Motley Fool Australia.

COVID-19 cases and deaths continue to rise in the United States. Some states are being hit especially hard. While researchers and physicians have learned a lot about the disease caused by novel coronavirus SARS-CoV-2, there seems to be no end in sight to the ongoing pandemic.

The good news, though, is that a frantic – and massive – effort is under way to develop vaccines that could potentially prevent the spread of COVID-19. Here's everything you need to know about the coronavirus vaccine race.

How many vaccine candidates are being developed?

As of July 31, 2020, there are 165 novel coronavirus vaccine candidates in development, according to the World Health Organization. However, 139 of these candidates are in preclinical testing. Many of these candidates might not advance into clinical testing in humans. The good news is that 26 COVID-19 vaccine candidates are already in clinical testing. 

Which vaccine candidates are in the lead?

Clinical testing of vaccines includes three phases. Candidates must successfully complete phase 1 testing to go on to phase 2 and then must successfully complete phase 2 testing to advance into phase 3.

There are currently five COVID-19 vaccine candidates in phase 3 testing, also commonly referred to as late-stage testing. Chinese drugmaker Sinopharm claims two of these candidates. Another Chinese company, Sinovac Biotech, also has a COVID-19 vaccine candidate in phase 3 testing. The other two late-stage candidates are AZD1222, which is being developed by AstraZeneca (NYSE: AZN) and the University of Oxford, and Moderna's (NASDAQ: MRNA) mRNA-1273.

In addition, Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) recently began a phase 2/3 clinical study evaluating COVID-19 vaccine candidate BNT162b2.

How do the leading vaccine candidates differ?

The vaccine candidates from Sinopharm and Sinovac use inactivated (dead) coronavirus cells that are introduced to the body. AstraZeneca and the University of Oxford are using what's called a non-replicating viral vector. This approach uses a weakened version of an adenovirus (which causes the common cold) to deliver genetic material from the SARS-CoV-2 virus. 

Moderna and the Pfizer/BioNTech partnership use a messenger RNA (mRNA) approach. While DNA contains all of the instructions for building proteins, mRNA carries those instructions to ribosomes, which serve as the body's protein-making factories. The COVID-19 vaccine candidates developed by Moderna and Pfizer/BioNTech modify mRNA to cause ribosomes to produce spike proteins that are identical to those found in SARS-CoV-2.

The ultimate goal of all of these vaccines is to cause the body to develop antigens that remain in the blood and help fight off future viral attacks. 

Which vaccines not among the leaders could be winners?

Two COVID-19 vaccine candidates currently in clinical testing have received significant funding and appear to be especially promising. 

Novavax (NASDAQ: NVAX) received $1.6 billion from the U.S. government for developing COVID-19 vaccine candidate NVX-CoV2373. Johnson & Johnson (NYSE: JNJ) also was awarded $456 million in funding for its coronavirus vaccine candidate. 

There's also an experimental COVID-19 vaccine that hasn't advanced into clinical testing that scored a major U.S. government funding deal recently. Sanofi (NASDAQ: SNY) and GlaxoSmithKline (NYSE: GSK) were awarded $2.1 billion for up to 100 million doses of a preclinical coronavirus vaccine candidate. 

How soon might a vaccine be available?

In the past, it's taken years for vaccines to advance through clinical testing and win regulatory approvals. However, the normal timeline is being accelerated greatly as a result of the COVID-19 pandemic.

Opinions vary as to how soon a coronavirus vaccine will be available. Some CEOs of companies making vaccine candidates think their COVID-19 vaccine candidates could be ready by the end of this year. Others believe that early 2021 is more likely. However, there are also some less optimistic predictions that it could take much longer before a safe and effective COVID-19 vaccine is ready.

What are the chances that no vaccine will be safe and effective?

You'll probably be happy to learn that the chances that none of the COVID-19 vaccine candidates in development will be safe and effective are quite low. Nearly three out of four vaccines that entered phase 3 testing between 2006 and 2015 went on to win FDA approval, according to biopharmaceutical industry organization BIO. 

Since there are currently six coronavirus vaccine candidates in late-stage testing or close to it, the probability that none of them will win approval based on BIO's historical analysis is only one in 3,470. If we included all of the other candidates in phase 1 and phase 2 clinical testing, the odds are heavily in favor of at least one of them achieving success.

Which coronavirus vaccine stocks are good picks?

The Motley Fool's mission is to make the world smarter, happier, and richer. Therefore, we can't leave out addressing the investing angle of the coronavirus vaccine race. 

If your investing style is more conservative, big pharma stocks like AstraZeneca and Pfizer could be attractive. Both companies are leaders in the scramble to develop a COVID-19 vaccine. Both have landed major supply contracts already. And both AstraZeneca and Pfizer have other growth drivers in addition to their COVID-19 programs.

On the other hand, if you're an aggressive investor, Moderna and Novavax might be more to your liking. Both biotech stocks have soared this year. But if their COVID-19 vaccine candidates are successful in clinical testing, Moderna and Novavax could go a lot higher.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

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