February 24, 2024

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Can recombinant protein vaccine beat mRNA technology on influenza vaccine?

Can recombinant protein vaccine beat mRNA technology on influenza vaccine?



 

Can recombinant protein vaccine beat mRNA technology on influenza vaccine?

After being surpassed by mRNA technology, the developer of recombinant protein vaccine is on the verge of bankruptcy. Can it be brought back to life with the help of influenza vaccine?


As the global COVID-19 epidemic gradually stabilizes, biotechnology companies that use vaccines as their main products may be pushed into a “trough period” by the market.

 

On February 28, 2023, Novavax (NASDAQ: NVAX), a vaccine manufacturer headquartered in Maryland, USA, pointed out after announcing its 2022 financial report that because the company’s previous sales of COVID-19 vaccines did not meet expectations, the company is currently is in the throes of cash depletion.

The company said it was skeptical that the company would survive the next year.

 

” Uncertainty ” was the key word in Novavax’s fourth-quarter earnings call. Although current cash flow forecasts suggest that Novavax still has the strength to support it through 2023, it is clear that the company is not so confident about its next development that it has not given any revenue forecasts for it in 2023.

Affected by this, Novavax’s after-hours stock price plummeted 25%, and the current price per share is $6.94, which is indeed disappointing compared with its share price of as high as $315.9 in 2021.

 

Can recombinant protein vaccine beat mRNA technology on influenza vaccine?

 

In this regard, John C. Jacobs, the company’s chief executive officer, formulated a short-term Novavax development plan.

 Including preparing for the upcoming “vaccination season”, may cut costs through layoffs, and will continue to promote the commercialization of new products to seek more opportunities.

 

 


Epidemic race: Recombinant protein vaccines are completely crushed by mRNA technology

 

This is not the first time Novavax has faced a financial crisis. As early as 2019, the company was on the verge of bankruptcy after the RSV vaccine failed in clinical trials.

In order to save cash, Novavax at the time sold its two manufacturing plants in Maryland and laid off more than half of its employees to “survive”.

 

In 2020, the sudden COVID-19 epidemic seems to have brought Novavax an opportunity to change its fate.

 

Immediately after the outbreak, Novavax announced that it would invest in the research and development of the COVID-19 vaccine.

Immediately, a large amount of funds poured into this company that was once on the verge of bankruptcy: in May 2020, the Global Epidemic Alliance (CEPI) provided Novavax with US$400 million in research and development funding; in July 2020, the company received another 1.6 billion US dollar funds, its stock price has also risen nearly a hundred times within a few months.

 

However, this opportunity did not actually favor the field of recombinant protein vaccines . Under the influence of the lengthy R&D cycle, Novavax, who entered the market at the first time, was dragged into the “last person to submit the paper”.

 

As a vaccine company with a history of more than 30 years, Novavax adopts a traditional protein-based vaccine development strategy.

Taking its COVID-19 vaccine Nuvaxovid (NVX-CoV2373) as an example, researchers first need to improve and determine a sufficiently stable spike protein based on the spike protein of the original virus, and then use the baculovirus to insert the gene of the spike protein into the fly. moth cells, thereby producing a large number of spike proteins on their cell membranes.

Finally, an adjuvant is added to the prepared spike protein to enhance its immune response in vivo. Undoubtedly, these complicated steps will delay the development of protein vaccines.

 

Can recombinant protein vaccine beat mRNA technology on influenza vaccine?

COVID-19 vaccine NVX-CoV2373 research and development strategy (source: Novavax)

 

In August 2020, Novavax announced Phase I/II clinical phase data for its COVID-19 vaccine, showing that the protein vaccine outperformed its main competitor in the market on key indicators, and was stable at 2-8°C. The stability exhibited under these conditions is also satisfactory.

 

These data results weave a wonderful vision for Novavax managers. In their vision, Sanofi, which also takes the route of protein vaccines , may be its biggest competitor. However, what they did not expect was that protein vaccines were completely crushed by mRNA vaccines in the epidemic race, and Novavax also missed the opportunity.

 

Only four months later, in December 2020, the mRNA COVID-19 vaccines from Pfizer/BioNTech and Moderna successively received Emergency Use Authorization (EUA) issued by the FDA, and agencies began to distribute and organize vaccinations immediately after approval.

 

At this time, the phase III clinical trial of Novavax recombinant protein vaccine has just started. By July 2022, after a lengthy clinical trial and regulatory approval, the Novavax recombinant protein vaccine has finally received the FDA’s Emergency Use Authorization (EUA), but it has been a year and seven months since the mRNA vaccine was launched , The COVID-19 vaccine market has no place for Novavax.

 

What’s more, in the face of the rapidly mutating new coronavirus, the strong scalability of the mRNA vaccine has made it highly acclaimed. In contrast, protein vaccines that need to expand the pipeline are slightly inadequate.

 

 

 

 


There has not been a “dark horse” in the field of flu vaccines, and Novavax will expand its pipeline to seek opportunities

 

According to the 2022 financial report released by Novavax, the company’s sales in the fourth quarter of last year were 357 million U.S. dollars, and its full-year revenue in 2022 is only 1.9 billion U.S. dollars. Far less than the $4 billion to $5 billion the company expected in May last year, it was a big disappointment.

 

Novavax, on the other hand, still has about $1.3 billion in debt as of December 31, 2022. While that figure is down from more than $1.5 billion at the end of 2021, the company has so far struggled to reverse its continued losses.

 

However, as a company that has been hit repeatedly but is still standing today, Novavax’s vitality is always astonishing.

In April 2022, Novavax announced that another of the company’s COVID-19/influenza combination (CIC) vaccines had achieved preliminary results in phase I/II clinical studies.

In December last year, the company announced that it had initiated a phase II clinical trial of the COVID-19/flu combination vaccine and the candidate influenza vaccine to complete dose confirmation. Novavax is expected to have topline results from the trial by mid-2023.

 

Can recombinant protein vaccine beat mRNA technology on influenza vaccine?Novavax R&D pipeline (Source: Novavax)

 

Novavax CEO John C. Jacobs ‘ plans, on the other hand, show the company’s last-ditch effort to find a place for traditional protein vaccines in its market.

 

According to him, Novavax will seek development in three directions. First, Novavax has until this fall to have an updated vaccine ready for a possible new wave of infections.

Second, the company must reduce spending and expand cash flow. Finally, Novavax needs to expand its new product pipeline as soon as possible to increase its revenue stream.

 

From the first point of view, it is not easy for Novavax to break through the COVID-19 vaccine market, because the relatively slow research and development progress of recombinant protein vaccines has always been a difficult problem for such companies

. At present, Novavax is still continuing to promote its vaccine against the Omicron (B.1.1.529) variant, but relevant industry insiders do not have much expectation for it.

 

Especially as countries have successively suspended emergency plans related to the COVID-19 epidemic, it is an indisputable fact that the global demand for COVID-19 vaccines has declined.

Not only Novavax, but the stock prices of Pfizer, BioNTech and Moderna, representatives of mRNA vaccine technology, will also begin to fall in 2022.

From the data point of view, the current price per share of Moderna is 143.20 US dollars, which is also far from its peak value of 484.47 in 2021.

 

In addition, relevant industry insiders said that it remains to be seen whether Novavax can profit in the COVID-19/flu combination vaccine and candidate flu vaccine race. While Novavax still isn’t the fastest-moving manufacturer in the space so far, its competitors are also struggling.

 

Recently, Moderna, which has advanced its flu vaccine candidate into phase III clinical trials, found that its experimental mRNA-based flu vaccine produced a strong immune response against influenza A viruses, but was even less effective against less prevalent influenza B viruses. Not as good as the existing inactivated vaccines.

In addition to Moderna, Pfizer and BioNTech, GlaxoSmithKline (GSK) and Sanofi are also cooperating to promote related pipelines, but their progress is not as good as that of Moderna. Among them, Pfizer claimed last year that the mRNA vaccine of the COVID-19/flu combination may be launched in 2024 and later.

 

Regardless, the news gave Novavax some respite. As for whether it can “return to life” again, relevant industry insiders are unable to give an answer.

 

 

 

 

 

 

 

 

 

References:
1. https://www.novavax.com/
2. https://ir.novavax.com/2023-02-28-Novax-Reports-Fourth-Quarter-and-Full-Year-2022-Financial-Results-and-Operational-Highlights
3. https://ir.novavax.com/2022-12-30-Novax-Announces-Initiation-of-Phase-2-Trial-for-COVID-19-Influenza-Combination-and-Stand-Alone-Influenza- Vaccine-Candidates
4. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Interim-Phase-3-Safety-and-Immunogenicity-Results-for-mRNA-1010-a-Seasonal-Influenza- Vaccine-Candidate/default.aspx
5. https://doi.org/10.1056/nejmoa2026920

Can recombinant protein vaccine beat mRNA technology on influenza vaccine?

(source:internet, reference only)


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