Friday, March 31

Novavax: The long road to success

Novavax is a US biotechnology company

The company’s corona vaccine is intended to improve the vaccination rate in Germany

The vaccine developer nearly went bankrupt in 2019

Nuvaxovid as savior of the vaccination quota?

Nuvaxovid – the vaccine from the manufacturer Novavax is considered a beacon of hope when it comes to vaccination rates. The so-called dead vaccine may be able to convince people who were previously critical of mRNA technology to get vaccinated. According to ZDF, around 1.75 million doses of the corona vaccine are to be delivered by February 21. The difference between Nuvaxovid and the mRNA vaccines lies in the spike protein. This triggers the immune response and is already present in the Novavax vaccine. With the mRNA vaccines, the body cells have to produce the spike protein themselves based on the vaccine.

The Novavax vaccine therefore has a lot of potential. But what is behind the company from the USA? What’s his story?

The vaccines against SARS, MERS and Ebola failed

Novavax is a “biotechnology company that advances better health worldwide through the discovery, development and commercialization of innovative vaccines that prevent serious infectious diseases.” On the company website, the vaccine developer advertises decades of experience in the fight against devastating diseases such as RSV, Ebola, MERS and SARS. However, according to the Tagesschau, the company, which was founded in 1987 and originates from the US state of Maryland, was able to record the greatest and only success in the company’s history with the approval of the corona vaccine Nuvaxovid by the European Commission.

Before the company refocused its efforts on COVID-19 in 2020, it failed on various other projects. According to the company, it developed a vaccine candidate against SARS in 2005 and against MERS in 2012. Both diseases belong to the corona virus family. In 2014, the company, together with the University of Maryland School of Medicine, published results that proved the effectiveness of the two vaccine candidates. However, the two candidates against SARS and MERS did not make it into the clinical phase 1 study, in which vaccines are tested on humans for the first time. The Ebola vaccine developed by Novavax, on the other hand, made it into the phase 1 study, but is not in active development according to the company.

According to Manager Magazin, Novavax also produced estrogen ointments and prenatal vitamins – but their sales were unsuccessful. In the field of seasonal flu, however, vaccine development is looking better. Novavax’s NanoFlu seasonal influenza vaccine has successfully completed Phase 3 trials and is now awaiting US Food and Drug Administration (FDA) approval.

Nuvaxovid is the only successful vaccine Novavax has ever brought to market

Nuvaxovid is the first vaccine that the vaccine manufacturer is actually bringing to the market. Drug misdevelopments left Novavax on the brink of bankruptcy by the end of 2019 — largely due to the failure of a vaccine it was trying to develop against a virus that attacked the respiratory tract, particularly in young children. According to Forbes magazine, the Bill and Melinda Gates Foundation provided $89 million for the development of the so-called respiratory syncytial virus (RSV) vaccine. In return, Novavax undertook to sell the vaccine in developing countries at a favorable price. However, the vaccine candidate did not progress beyond the phase 1 study. According to Manager Magazine, Novavax CEO Stanley C. Erck previously predicted that the respiratory virus vaccine could become “the best-selling vaccine in vaccine history by revenue.”

The consequences of the failure: The company had to part with production facilities and employees. In addition, there was even a risk that the share would be blown out of the US technology exchange NASDAQ. This could only be avoided because every 20 shares were combined into one. The company has now stabilized again with a market capitalization of more than six billion US dollars. Another RSV vaccine from Novavax is much more successful. According to Novavax, ResVax is intended to protect infants through maternal immunization and at least made it into the phase 3 study. However, the vaccine has not yet been approved. CEO Erck appears to have learned from his mistakes and is reticent about the Wall Street Journal. When asked about his company’s new corona vaccine, he replied: “We know that we are late. After all, almost all of the biggest challenges have now been overcome and we can clearly see the light at the end of the tunnel”.

Production of the Corona vaccine had its ups and downs

Thanks to the Corona crisis and the vaccine Nuvaxovid, Novavax can hope for success again. But the development of the corona vaccine was also a rocky road. The vaccine was submitted to the FDA for clinical trials at the same time as BioNTech’s vaccine. BioNTech was then able to quickly produce its vaccine – Novavax faced problems again.

For one thing, the virus gene sample ordered from China did not arrive due to canceled flights. On the other hand, production partners canceled, which delayed the study. By the time the study was ready, all the other vaccines were already on the market. In addition, 5,000 subjects dropped out because they didn’t want to be injected with just a placebo when in doubt. Despite this, the company received around 1.6 billion US dollars in support from the US government in 2020. This was based on then-President Donald Trump’s “Warp Speed” vaccine operation. According to health blog FiercePharma, the Coalition for Epidemic Preparedness Innovations (CEPI), a global coalition supporting COVID-19 vaccine development, also supported the manufacturing of Novavax’s Corona vaccine with $384 million. With these cash injections, the company managed to develop an effective corona vaccine despite all the setbacks.

Tim Adler / Editor

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