In the last few months, the COVID-19 vaccines developed by Modern (NASDAQ: MRNA) and Pfizer (NYSE: PFE) together with your partner BioNTech (NASDAQ: BNTX) have been in the spotlight. Both vaccines have received emergency use authorization (USA) in the USA, the United Kingdom, the 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 on Thursday, another drugmaker announced positive results from a final-stage study of its vaccine COVID-19. Care, Pfizer and Moderna: here it comes Novavax (NASDAQ: NVAX).
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A true competitor
Novavax’s results from its final stage study conducted in the UK are expected to make its COVID-19 vaccine, NVX-CoV2373, a true candidate. Biotechnology reported that its vaccine achieved 89.3% effectiveness.
Of course, this is slightly below the 94.1% and 95% effectiveness for the Moderna and Pfizer / BioNTech vaccines, respectively. However, it is definitely close enough to place NVX-CoV2373 in the top layer of COVID-19 vaccines. When complete data is available, the small gap can potentially 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 shipped in a ready-to-use liquid formulation. The Pfizer / BioNTech vaccine requires ultracold storage. Moderna’s COVID-19 vaccine remains stable at standard refrigerator temperatures for up to 30 days.
Stanley Erck, CEO of Novavax, correctly noted that “NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19, but also significant clinical efficacy against emerging variants in the UK and South Africa”. Pfizer / BioNTech and Moderna have released results of studies in test tubes that indicate that their vaccines must be effective against these new variants of the coronavirus. However, they have reported no results from clinical studies in humans that demonstrate efficacy with the UK and South Africa variants.
However, there were some potentially worrying signs reported by Novavax that could also be concerns for Pfizer and Moderna. In a separate phase 2b study conducted in South Africa, NVX-CoV2373 achieved only 60% effectiveness in HIV-negative participants and 49.4% overall effectiveness. Most patients who were later diagnosed with COVID-19 were infected with the South African variant. Novavax plans to move forward with clinical studies for combined bivalent boosters and / or vaccines targeting new strains of coronavirus.
It’s still a waiting game in the USA
The Novavax announcement is great news for people in the UK. Clive Dix, acting chairman of the UK Vaccine Task Force, 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 waiting game in the USA. Novavax started its NVX-CoV2373 Prevent-19 final stage study in the US and Mexico in late December.
Novavax enrolled and randomized more than 16,000 participants in the Prevent-19 study. The company expects to complete the planned enrollment of 30,000 patients in the first half of February. This is encouraging, since there have been some concerns about the registration of two COVID-19 vaccines already available to many Americans.
How long can it take before the NVX-CoV2373 can receive USA in the USA? The Food and Drug Administration (FDA) requires monitoring study participants for at least two months after they have been fully vaccinated. The second dose of the Novavax vaccine is given 21 days after the first dose. This means that the earliest that biotechnology will be able to complete its analysis is probably in mid-March. Assuming everything goes well, it is possible that the NVX-CoV2373 could win US FDA in April.
Time to buy?
With the exciting news from Novavax, is it time to buy biotech stocks? Or is it too late? I have long argued that Novavax is a good choice. I don’t think it’s too late to accumulate shares.
I fully expect Novavax to obtain permits in the UK and then obtain permits in other countries. The grand prize is the American market. Even with the federal government increasing its supply agreements with Pfizer and Moderna, I suspect NVX-CoV2373 will still be on track to win the US if the results of the final-stage Prevent-19 study are similar to the Novavax study in the UK United.
The signs indicate that COVID-19 is becoming similar to seasonal flu, requiring vaccination annually. Assuming that is the case, Novavax could realistically generate multi-billion dollar annual sales. He also has a promising flu vaccine that must be subject to NanoFlu regulation. The company is exploring the potential of combining its two main candidates into a combined vaccine COVID-19 / flu. I think you can be a big winner if you are successful.
One thing is clear, however, after Novovax’s announcement on Thursday: Pfizer / BioNTech and Moderna are soon set to have a formidable rival in the COVID-19 vaccine market.