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Emerging Themes in the COVID-19 Vaccine Space (MRNA, PFE, DYAI, JNJ, NVAX, BNTX, AZN)

Pfizer and its partner, BioNTech, announced a few days ago that they plan to ask U.S. and European regulators to authorize a booster dose of their COVID-19 vaccine very soon. Why? They claim it is because of “evidence of greater risk of infection six…

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Pfizer and its partner, BioNTech, announced a few days ago that they plan to ask U.S. and European regulators to authorize a booster dose of their COVID-19 vaccine very soon. Why? They claim it is because of “evidence of greater risk of infection six months after inoculation and the spread of the highly contagious Delta variant”.

For most, it is hard to argue with the reasoning. Though it may seem like a financial or fiduciary risk on the part of taxpayers to simply accept this idea without more information. 

First of all, because the process of producing and distributing the expensive and difficult-to-store and difficult-to-transport vaccine is far from simple and cheap. And, ultimately, we all know who will have to bear that cost.

For their parts, the FDA and CDC said, in a joint statement, that “Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time”.

However, demand and future data will ultimately tell the tale. It’s likely a story that hasn’t been written yet, but one that has an unpleasant vector marked by the prospects of the variant tree continuing to yield new offspring that end up pushing the envelope past its secure boundaries.

In any event, it would be clearly beneficial to land upon a means of producing protection for the long term that doesn’t necessitate paying hundreds of billions of dollars every few months. Alas, the search goes on.

Impacted by this narrative are the usual suspects, including Moderna Inc (NASDAQ:MRNA), Pfizer Inc. (NYSE:PFE), Dyadic International, Inc. (NASDAQ:DYAI), Johnson & Johnson (NYSE:JNJ), Novavax, Inc. (NASDAQ:NVAX), BioNTech SE – ADR (NASDAQ:BNTX), and AstraZeneca plc (NASDAQ:AZN).

We take a closer look at some of the more interesting stories in this space below.

 

Moderna Inc (NASDAQ:MRNA) is perhaps the most prominent name in the COVID-19 space at this point because it was first-to-market in the revolutionary new mRNA vaccine space last fall and has been swallowing up the lion’s share of press on the subject ever since as a first mover. The company engages in the development of transformative medicines based on messenger ribonucleic acid (mRNA), according to its materials.

MRNA’s product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intra-tumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics.

Moderna Inc (NASDAQ:MRNA) recently announced a supply agreement with the government of Argentina for 20 million doses of Moderna’s COVID-19 vaccine or its updated variant booster vaccine candidate, if authorized, to begin delivery in the first quarter of 2022.

“We appreciate the support from the government of Argentina with this supply agreement for doses of the Moderna COVID-19 vaccine or our variant booster candidates,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are committed to making our vaccine available around the world as we seek to address the pandemic with our COVID-19 vaccine.”

MRNA shares have been acting reasonably well over recent days, up several percent in that time.

Moderna Inc (NASDAQ:MRNA) pulled in sales of $1.9B in its last reported quarterly financials. That pairs with some balance sheet hurdles, as cash levels struggle to keep up with current liabilities ($7.7B against $8.4B, respectively).

 

Dyadic International Inc (NASDAQ:DYAI) is a strong dark horse candidate in the race to reshape the global vaccine landscape. For a little background, DYAI has a new approach that could become a better way to deal with new variants and even possibly better able to drive cheap and efficient production capable of vaccinating the world. 

The jewel in this new model is its proprietary process involving the C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins and has the potential to be further developed into a safe and efficient expression system that may help speed up the development of biologic vaccines and drugs at commercial scales, while lowering production costs and improving performance at the same time.

To further advance this narrative, Dyadic International, Inc. (NASDAQ:DYAI) recently announced findings from the Zoonotic Anticipation and Preparedness Initiative (ZAPI) project which has been published in VACCINES, a leading peer-reviewed scientific journal.

“Zoonotic diseases represent a serious global threat to human and animal health. The majority of newly evolving pathogens are zoonotic viruses. Safe and effective vaccines that can be developed rapidly following an outbreak are required to effectively combat these diseases. The efficacy, protection and safety data reported from the ZAPI study further supports the mounting library of data – demonstrating a novel approach for the C1 expression platform to be broadly applied for rapid development and manufacturing of vaccines for both human and animals”. Dr. Tchelet further commented “we anticipate additional partnerships and external collaborations which will serve to further advance our commercial objectives”.

According to the release, the successful ZAPI program focused on the following goals to enable the delivery of targeted vaccines for humans and animals, as well as therapeutic antibodies for hospital use, rapidly following a future disease outbreak by identifying the best protective subunit vaccines and neutralizing antibodies against potential new zoonotic diseases or strains, such as bunyaviruses (i.e., Rift Valley fever virus and Schmallenberg virus) or coronaviruses (i.e., Middle East respiratory syndrome coronavirus or MERS Co-V); defining optimal manufacturing technologies and processes for these vaccines and antibodies to enable high-volume production capacity; obtaining alignment with regulatory authorities and policy makers; and securing pre-approval of new vaccine and antibody manufacturing methodologies for future emerging zoonotic viral diseases.

As noted by the company, this peer-reviewed study clearly seems to demonstrate the successful use of DYAI’s patented and proprietary C1-cell protein production platform to facilitate a fast, coordinated, and practical response to new infectious diseases as soon as they emerge – a striking advantage given infectious disease dynamics in the 21st century.

Dyadic International, Inc. (NASDAQ:DYAI) pulled in sales of $461K in its last reported quarterly financials. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($27.2M against $2.6M). However, the commercial opportunity is still ahead in this name as it works to secure a disruptive position in the global vaccine marketplace at a time when disruptive vaccine technology is at a powerful premium.

 

Novavax, Inc. (NASDAQ:NVAX) focuses on the discovery, development and commercialization of vaccines to prevent infectious diseases.

It provides vaccines for COVID-19, seasonal flu, respiratory syncytial virus, Ebola, and Middle East respiratory syndrome.

Novavax, Inc. (NASDAQ:NVAX) recently announced the publication of results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candidate conducted in the United Kingdom in the New England Journal of Medicine (NEJM). The final analysis confirmed an overall efficacy of 89.7% with over 60% (half) of the cases caused by the B.1.1.7 (Alpha) variant, and a 96.4% efficacy against non-B.1.1.7 (non-Alpha) variants which represents strains most similar to the original virus.

“We continue to be very encouraged by data showing high levels of efficacy against even mild disease, and that NVX-CoV2373 offers strong cross-protection against both the B.1.1.7 (Alpha) variant and non-B.1.1.7 (non-Alpha) variant strains which are widely circulating,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “This publication also reinforces the reassuring safety and efficacy profile shown in studies of our vaccine to-date and underscores the potential for NVX-CoV2373 to play an important role in solving this ongoing global public health crisis.”

While this is a clear factor, it has been incorporated into a trading tape characterized by a pretty dominant offer, which hasn’t been the type of action NVAX shareholders really want to see. In total, over the past five days, shares of the stock have dropped by roughly -13% on above average trading volume. All in all, not a particularly friendly tape, but one that may ultimately present some new opportunities. 

Novavax, Inc. (NASDAQ:NVAX) pulled in sales of $447.2M in its last reported quarterly financials. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($2B against $1.2B).

Please make sure to read and completely understand our disclaimer at https://www.wallstreetpr.com/disclaimer. We may be compensated for posting this content on our website by EDM Media LLC. For questions, comments or suggestions please contact steve@edm.media.

The post Emerging Themes in the COVID-19 Vaccine Space (MRNA, PFE, DYAI, JNJ, NVAX, BNTX, AZN) appeared first on Wall Street PR.

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Government

Mathematicians use AI to identify emerging COVID-19 variants

Scientists at The Universities of Manchester and Oxford have developed an AI framework that can identify and track new and concerning COVID-19 variants…

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March 11, 2024

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Scientists at The Universities of Manchester and Oxford have developed an AI framework that can identify and track new and concerning COVID-19 variants and could help with other infections in the future.

Credit: source: https://phil.cdc.gov/Details.aspx?pid=23312

Scientists at The Universities of Manchester and Oxford have developed an AI framework that can identify and track new and concerning COVID-19 variants and could help with other infections in the future.

The framework combines dimension reduction techniques and a new explainable clustering algorithm called CLASSIX, developed by mathematicians at The University of Manchester. This enables the quick identification of groups of viral genomes that might present a risk in the future from huge volumes of data.

The study, presented this week in the journal PNAS, could support traditional methods of tracking viral evolution, such as phylogenetic analysis, which currently require extensive manual curation.

Roberto Cahuantzi, a researcher at The University of Manchester and first and corresponding author of the paper, said: “Since the emergence of COVID-19, we have seen multiple waves of new variants, heightened transmissibility, evasion of immune responses, and increased severity of illness.

“Scientists are now intensifying efforts to pinpoint these worrying new variants, such as alpha, delta and omicron, at the earliest stages of their emergence. If we can find a way to do this quickly and efficiently, it will enable us to be more proactive in our response, such as tailored vaccine development and may even enable us to eliminate the variants before they become established.”

Like many other RNA viruses, COVID-19 has a high mutation rate and short time between generations meaning it evolves extremely rapidly. This means identifying new strains that are likely to be problematic in the future requires considerable effort.

Currently, there are almost 16 million sequences available on the GISAID database (the Global Initiative on Sharing All Influenza Data), which provides access to genomic data of influenza viruses.

Mapping the evolution and history of all COVID-19 genomes from this data is currently done using extremely large amounts of computer and human time.

The described method allows automation of such tasks. The researchers processed 5.7 million high-coverage sequences in only one to two days on a standard modern laptop; this would not be possible for existing methods, putting identification of concerning pathogen strains in the hands of more researchers due to reduced resource needs.

Thomas House, Professor of Mathematical Sciences at The University of Manchester, said: “The unprecedented amount of genetic data generated during the pandemic demands improvements to our methods to analyse it thoroughly. The data is continuing to grow rapidly but without showing a benefit to curating this data, there is a risk that it will be removed or deleted.

“We know that human expert time is limited, so our approach should not replace the work of humans all together but work alongside them to enable the job to be done much quicker and free our experts for other vital developments.”

The proposed method works by breaking down genetic sequences of the COVID-19 virus into smaller “words” (called 3-mers) represented as numbers by counting them. Then, it groups similar sequences together based on their word patterns using machine learning techniques.

Stefan Güttel, Professor of Applied Mathematics at the University of Manchester, said: “The clustering algorithm CLASSIX we developed is much less computationally demanding than traditional methods and is fully explainable, meaning that it provides textual and visual explanations of the computed clusters.”

Roberto Cahuantzi added: “Our analysis serves as a proof of concept, demonstrating the potential use of machine learning methods as an alert tool for the early discovery of emerging major variants without relying on the need to generate phylogenies.

“Whilst phylogenetics remains the ‘gold standard’ for understanding the viral ancestry, these machine learning methods can accommodate several orders of magnitude more sequences than the current phylogenetic methods and at a low computational cost.”

Journal

Proceedings of the National Academy of Sciences

DOI

10.1073/pnas.2317284121

Article Title

Unsupervised identification of significant lineages of SARS-CoV-2 through scalable machine learning methods

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International

There will soon be one million seats on this popular Amtrak route

“More people are taking the train than ever before,” says Amtrak’s Executive Vice President.

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March 11, 2024

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While the size of the United States makes it hard for it to compete with the inter-city train access available in places like Japan and many European countries, Amtrak trains are a very popular transportation option in certain pockets of the country — so much so that the country’s national railway company is expanding its Northeast Corridor by more than one million seats.

Related: This is what it's like to take a 19-hour train from New York to Chicago

Running from Boston all the way south to Washington, D.C., the route is one of the most popular as it passes through the most densely populated part of the country and serves as a commuter train for those who need to go between East Coast cities such as New York and Philadelphia for business.

Veronika Bondarenko captured this photo of New York’s Moynihan Train Hall. 

Veronika Bondarenko

Amtrak launches new routes, promises travelers ‘additional travel options’

Earlier this month, Amtrak announced that it was adding four additional Northeastern routes to its schedule — two more routes between New York’s Penn Station and Union Station in Washington, D.C. on the weekend, a new early-morning weekday route between New York and Philadelphia’s William H. Gray III 30th Street Station and a weekend route between Philadelphia and Boston’s South Station.

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According to Amtrak, these additions will increase Northeast Corridor’s service by 20% on the weekdays and 10% on the weekends for a total of one million additional seats when counted by how many will ride the corridor over the year.

“More people are taking the train than ever before and we’re proud to offer our customers additional travel options when they ride with us on the Northeast Regional,” Amtrak Executive Vice President and Chief Commercial Officer Eliot Hamlisch said in a statement on the new routes. “The Northeast Regional gets you where you want to go comfortably, conveniently and sustainably as you breeze past traffic on I-95 for a more enjoyable travel experience.”

Here are some of the other Amtrak changes you can expect to see

Amtrak also said that, in the 2023 financial year, the Northeast Corridor had nearly 9.2 million riders — 8% more than it had pre-pandemic and a 29% increase from 2022. The higher demand, particularly during both off-peak hours and the time when many business travelers use to get to work, is pushing Amtrak to invest into this corridor in particular.

To reach more customers, Amtrak has also made several changes to both its routes and pricing system. In the fall of 2023, it introduced a type of new “Night Owl Fare” — if traveling during very late or very early hours, one can go between cities like New York and Philadelphia or Philadelphia and Washington. D.C. for $5 to $15.

As travel on the same routes during peak hours can reach as much as $300, this was a deliberate move to reach those who have the flexibility of time and might have otherwise preferred more affordable methods of transportation such as the bus. After seeing strong uptake, Amtrak added this type of fare to more Boston routes.

The largest distances, such as the ones between Boston and New York or New York and Washington, are available at the lowest rate for $20.

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International

The next pandemic? It’s already here for Earth’s wildlife

Bird flu is decimating species already threatened by climate change and habitat loss.

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March 11, 2024

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I am a conservation biologist who studies emerging infectious diseases. When people ask me what I think the next pandemic will be I often say that we are in the midst of one – it’s just afflicting a great many species more than ours.

I am referring to the highly pathogenic strain of avian influenza H5N1 (HPAI H5N1), otherwise known as bird flu, which has killed millions of birds and unknown numbers of mammals, particularly during the past three years.

This is the strain that emerged in domestic geese in China in 1997 and quickly jumped to humans in south-east Asia with a mortality rate of around 40-50%. My research group encountered the virus when it killed a mammal, an endangered Owston’s palm civet, in a captive breeding programme in Cuc Phuong National Park Vietnam in 2005.

How these animals caught bird flu was never confirmed. Their diet is mainly earthworms, so they had not been infected by eating diseased poultry like many captive tigers in the region.

This discovery prompted us to collate all confirmed reports of fatal infection with bird flu to assess just how broad a threat to wildlife this virus might pose.

This is how a newly discovered virus in Chinese poultry came to threaten so much of the world’s biodiversity.

H5N1 originated on a Chinese poultry farm in 1997. ChameleonsEye/Shutterstock

The first signs

Until December 2005, most confirmed infections had been found in a few zoos and rescue centres in Thailand and Cambodia. Our analysis in 2006 showed that nearly half (48%) of all the different groups of birds (known to taxonomists as “orders”) contained a species in which a fatal infection of bird flu had been reported. These 13 orders comprised 84% of all bird species.

We reasoned 20 years ago that the strains of H5N1 circulating were probably highly pathogenic to all bird orders. We also showed that the list of confirmed infected species included those that were globally threatened and that important habitats, such as Vietnam’s Mekong delta, lay close to reported poultry outbreaks.

Mammals known to be susceptible to bird flu during the early 2000s included primates, rodents, pigs and rabbits. Large carnivores such as Bengal tigers and clouded leopards were reported to have been killed, as well as domestic cats.

Our 2006 paper showed the ease with which this virus crossed species barriers and suggested it might one day produce a pandemic-scale threat to global biodiversity.

Unfortunately, our warnings were correct.

A roving sickness

Two decades on, bird flu is killing species from the high Arctic to mainland Antarctica.

In the past couple of years, bird flu has spread rapidly across Europe and infiltrated North and South America, killing millions of poultry and a variety of bird and mammal species. A recent paper found that 26 countries have reported at least 48 mammal species that have died from the virus since 2020, when the latest increase in reported infections started.

Not even the ocean is safe. Since 2020, 13 species of aquatic mammal have succumbed, including American sea lions, porpoises and dolphins, often dying in their thousands in South America. A wide range of scavenging and predatory mammals that live on land are now also confirmed to be susceptible, including mountain lions, lynx, brown, black and polar bears.

The UK alone has lost over 75% of its great skuas and seen a 25% decline in northern gannets. Recent declines in sandwich terns (35%) and common terns (42%) were also largely driven by the virus.

Scientists haven’t managed to completely sequence the virus in all affected species. Research and continuous surveillance could tell us how adaptable it ultimately becomes, and whether it can jump to even more species. We know it can already infect humans – one or more genetic mutations may make it more infectious.

At the crossroads

Between January 1 2003 and December 21 2023, 882 cases of human infection with the H5N1 virus were reported from 23 countries, of which 461 (52%) were fatal.

Of these fatal cases, more than half were in Vietnam, China, Cambodia and Laos. Poultry-to-human infections were first recorded in Cambodia in December 2003. Intermittent cases were reported until 2014, followed by a gap until 2023, yielding 41 deaths from 64 cases. The subtype of H5N1 virus responsible has been detected in poultry in Cambodia since 2014. In the early 2000s, the H5N1 virus circulating had a high human mortality rate, so it is worrying that we are now starting to see people dying after contact with poultry again.

It’s not just H5 subtypes of bird flu that concern humans. The H10N1 virus was originally isolated from wild birds in South Korea, but has also been reported in samples from China and Mongolia.

Recent research found that these particular virus subtypes may be able to jump to humans after they were found to be pathogenic in laboratory mice and ferrets. The first person who was confirmed to be infected with H10N5 died in China on January 27 2024, but this patient was also suffering from seasonal flu (H3N2). They had been exposed to live poultry which also tested positive for H10N5.

Species already threatened with extinction are among those which have died due to bird flu in the past three years. The first deaths from the virus in mainland Antarctica have just been confirmed in skuas, highlighting a looming threat to penguin colonies whose eggs and chicks skuas prey on. Humboldt penguins have already been killed by the virus in Chile.

A colony of king penguins.
Remote penguin colonies are already threatened by climate change. AndreAnita/Shutterstock

How can we stem this tsunami of H5N1 and other avian influenzas? Completely overhaul poultry production on a global scale. Make farms self-sufficient in rearing eggs and chicks instead of exporting them internationally. The trend towards megafarms containing over a million birds must be stopped in its tracks.

To prevent the worst outcomes for this virus, we must revisit its primary source: the incubator of intensive poultry farms.

Diana Bell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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