analysis
Status: December 20, 2021 8:17 p.m.
US biotech company Novavax has made great strides in its plan to become the next global vaccine manufacturer. Could your protein-based vaccine break the dominance of BioNTech Pfizer and Moderna?
By Notker Blechner, tagesschau.de
For the 72-year-old Stanley Erck, it should be one of the more pleasant days in his life. The Novavax boss received the message from the European Medicines Agency in Amsterdam today: His company has received the green light from the EU for the conditional marketing authorization of the vaccine Nuvaxovid.
Largest step since approval in Southeast Asia
With this, Novavax has made an important breakthrough on its way to becoming a global corona vaccine supplier. So far, the US biotech company had only been granted the right to distribute the vaccine in Indonesia and the Philippines. Great Britain and Canada are currently still examining approval. And in the US, Novavax has not even filed for approval, but it plans to do so soon.
Fast production will now be essential. The company, based in Gaithersburg, Maryland, plans to create capacities for a good two billion vaccine doses in the coming year. The company recently announced that around 150 million cans could be produced by the end of this year. The product is manufactured by the Indian contract manufacturer Serum Institute – the largest vaccine manufacturer in the world.
200 million cans for the EU
Novavax has already signed a supply contract for over 100 million cans with the EU. Brussels has also secured an option for a further 100 million cans. Germany also relies on the US company. The federal government has requested 16 million Novavax cans for 2022. That’s less than ten percent of all corona vaccine orders. Berlin is planning a total of around 204 million vaccine doses.
The protein-based vaccine could be an alternative especially for vaccine skeptics who have reservations about the new mRNA technologies and vector vaccines. Studies have shown that the Novavax active ingredient is 90 percent effective against the coroavirus. The side effects were similar to other vaccines and were mainly pain at the injection site. There have been no reports of blood clots or heart problems, assures Novavax boss Erck.
Saponin as a vaccine booster
The Novavax vaccine works in a similar way to flu vaccines. It’s made with lab-grown copies of the spike protein that coats the coronavirus. After the vaccination, the human immune system uses it to generate antibodies against the protein and can thus fight off Covid 19 disease. The Novavax vaccine also contains saponin as a vaccination booster. Little research has been done on the side effects of saponin.
Novavax triggers an immune response similar to BioNTech / Pfizer and Moderna, says infectiologist Peter Kremsner, head of the Institute for Tropical Medicine at the University Hospital in Tübingen. “The protein sequence is almost the same as that of BioNTech and Moderna in the RNA sequence.”
Other manufacturers are also developing protein vaccines
The US manufacturer is not the only one to rely on protein-based vaccines. The pharmaceutical company Sanofi is also working on such a protein vaccine against Covid-19 and expects crucial study data in the first quarter of 2022. Experience with protein vaccines has been around for a long time, for example against flu or hepatitis B.
Experts are convinced that Novavax will steal market share from the two mRNA vaccine manufacturers BioNTech / Pfizer and Moderna. “Novavax should be a good alternative – especially for people who are afraid of mRNA,” says infectiologist Kremsner.
However, it will be very difficult for the US company to shake the leading position of the two mRNA specialists. A good 2.5 billion doses of the vaccine from the manufacturers BioNTech and Pfizer will probably be used this year. The Mainz biotech company BioNTech will generate income totaling 16 to 17 billion euros, half of which will be in profit. In the EU, manufacturers will produce a good three billion cans in 2021.
Particularly interesting for emerging markets
According to experts, Novavax is likely to have great potential, especially in the emerging markets. Because the agent can be stored at refrigerator temperatures. The vaccine is already being used en masse in Indonesia and the Philippines.
Novavax had sales of $ 476 million last year. The US company specializes in developing vaccines against influenza and the deadly Ebola virus. However, Novavax failed twice with a vaccine against so-called respiratory syncytial viruses, which can cause bronchitis, among other things. In 2015, Novavax received a $ 89 million grant from the Bill and Melinda Gates Foundation. For the development of a corona vaccine, the company received around 1.6 billion dollars from the US government under ex-President Donald Trump in 2020. The international vaccine alliance Cepi supported it with around 400 million dollars for vaccine development – and received 380 million doses in return.
Founded in 1987, the biotech company is listed on the Nasdaq technology stock exchange. The share has risen massively in the past two years. After standing at five dollars at the end of 2019, it is now trading at over 200 dollars.
Novavax boss Stanley Erck
Image: picture alliance / Kevin Dietsch
According to the World Health Organization (WHO), 26 vaccines have been approved worldwide to date. A few more are likely to follow. A total of around 350 vaccines against Covid-19 are in development. “There are far too many,” says infectiologist Kremsner. “Ten to 20 good ones are enough.”