Over the past few months, COVID-19 vaccines have been developed by Modern (NASDAQ: MRNA) and Pfizer (NYSE: PFE) with his partner BioNTech (NASDAQ: BNTX) was the center of attention. The two vaccines have been approved for emergency use (EUA) in the US, UK, European Union and other countries. They have already been given to millions of people.
However, there is a new big story in the coronavirus vaccine race. After the market closed Thursday, another drugmaker announced positive results from a late-stage study of its COVID-19 vaccine. Beware, Pfizer and Modern: here comes Novavax (NASDAQ: NVAX).
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A real contender
The results of Novavax from the late study conducted in the UK should make the COVID-19 vaccine, NVX-CoV2373, a true competitor. The biotechnology reported that the vaccine achieved 89.3% efficacy.
This is definitely a little lower than the efficiencies of 94.1% and 95% for the Moderna and Pfizer / BioNTech vaccines, respectively. However, it is definitely close enough to place NVX-CoV2373 in the highest level of COVID-19 vaccines. If complete data is available, the small gap could possibly be reduced.
Novavax may also have a distribution advantage. NVX-CoV2373 can be stored in standard refrigerators at temperatures between 36 degrees and 46 degrees Fahrenheit. It is sent in a ready-to-use liquid formulation. The Pfizer / BioNTech vaccine requires ultra-cold storage. Moderna’s COVID-19 vaccine remains stable at standard refrigerator temperatures for up to 30 days.
Stanley Erck, Novavax’s CEO, rightly remarked that ‘NVX-CoV2373 is the first vaccine to show not only high clinical efficacy against COVID-19, but also significant clinical efficacy against the rapidly emerging UK and South African variants. ‘ Pfizer / BioNTech and Moderna have released results from test tube studies suggesting that their vaccines should be effective against these new coronavirus variants. However, they did not show results from clinical trials in humans showing efficacy with the UK and South African variants.
There are some possible worrying signs reported by Novavax, but it could also be of concern to Pfizer and Moderna. In a separate phase 2b study conducted in South Africa, NVX-CoV2373 achieved only 60% efficacy in HIV-negative participants and 49.4% efficacy in general. Most patients who were later diagnosed with COVID-19 were infected with the South African variant. Novavax plans to continue clinical trials for boosters and / or combination of divalent vaccines targeting new coronavirus strains.
Still a wait in the US
The announcement of Novavax is good news for people in the UK Clive Dix, interim chairman of the UK Vaccine Taskforce, called the results ‘spectacular’. It seems very likely that Novavax will soon obtain authorization in the UK for NVX-CoV2373 based on its positive data.
However, it is still a wait-and-see game in the US. Novavax marked the end of 19 studies in the late stages of NVX-CoV2373 in the US and Mexico.
Novavax enrolled more than 16,000 participants in the Prevent-19 study and randomized. The company expects to complete its targeted enrollment of 30,000 patients in the first half of February. This is encouraging, as there are many concerns about enrolling in two COVID-19 vaccines that are already available to many Americans.
How long can it take for NVX-CoV2373 to receive EUA in the US? The Food and Drug Administration (FDA) requires study participants for at least two months after being fully vaccinated. The second dose of Novavax vaccine is given 21 days after the first dose. This means that biotechnology is likely to complete the earliest analysis, is mid-March. Assuming everything goes well, it is possible that NVX-CoV2373 could win EUA from the FDA in April.
Time to buy?
Is it time with the exciting news from Novavax to buy the biotechnology stock? Or is it too late? I have long maintained that Novavax is a good choice. I do not think it is too late to claim shares.
I fully expect Novavax to obtain authorizations in the UK and then obtain authorizations in other countries. The big price is the US market. Although the federal government is adding its offering with Pfizer and Moderna, I suspect NVX-CoV2373 will still be on track to win EUA if the results of the late-stage Prevent-19 study are similar to Novavax’s UK study.
Signs indicate that COVID-19 is similar to the seasonal flu, which needs to be vaccinated annually. Assuming this is the case, Novavax could realistically generate several billion dollars in annual sales. It also has a promising flu vaccine that regulates on NanoFlu. The company is exploring the potential of combining its two main candidates into a COVID-19 / flu vaccine combination. I think it can be a big winner if it is successful.
However, one thing is clear after the announcement of Novovax on Thursday: Pfizer / BioNTech and Moderna will soon have a huge competitor in the COVID-19 vaccine market.