Look Out, Pfizer and Moderna: here is Novavax

Over the past two months, COVID-19 vaccines developed by Modern (NASDAQ: ARNM) and Pfizer (NYSE: PFE) with his partner BioNTech (NASDAQ: BNTX) were the center of attention. Both vaccines have received Emergency Use Authorization (EUA) in the United States, United Kingdom, European Union and other countries. They have already been given to millions of people.

However, there is a big new story in the coronavirus vaccine race. After the market closed on Thursday, another drugmaker announced positive results from an advanced stage study of its COVID-19 vaccine. Attention, Pfizer and Moderna: here is Novavax (NASDAQ: NVAX).

Image source: Getty Images.

A real competitor

Novavax’s results from its advanced UK study should make its COVID-19 vaccine, NVX-CoV2373, a real competitor. Biotechnology reported that its vaccine reached an efficacy of 89.3%.

Of course, that’s a little below the 94.1% and 95% effectiveness of Moderna and Pfizer / BioNTech vaccines, respectively. However, it is certainly close enough to place NVX-CoV2373 in the top spot for COVID-19 vaccines. When complete data is available, the small gap could be reduced.

Novavax could also have a distribution advantage. The NVX-CoV2373 can be stored in standard refrigerators at temperatures between 36 degrees and 46 degrees Fahrenheit. It comes 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, 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 UK and African variants. from South.” Pfizer / BioNTech and Moderna have published the results of test-tube studies which indicate that their vaccines should be effective against these novel coronavirus variants. However, they did not report any results from clinical studies in humans demonstrating efficacy with the UK and South African variants.

However, some potentially worrying signs have been reported by Novavax which may also be of concern to Pfizer and Moderna. In another phase 2b study conducted in South Africa, NVX-CoV2373 only achieved 60% efficacy in HIV-negative participants and an overall efficacy of 49.4%. Most patients later diagnosed with COVID-19 were infected with the South African variant. Novavax plans to move forward with clinical studies on booster and / or bivalent combination vaccines targeting new strains of coronavirus.

Another waiting game in the United States

Novavax’s announcement is great news for the British. Clive Dix, acting chairman of the UK Vaccine Taskforce, called the results “spectacular”. It seems very likely that Novavax will soon obtain UK clearance for NVX-CoV2373 based on its positive data.

However, it’s still a waiting game in the United States. Novavax launched its advanced stage Prevent-19 study on NVX-CoV2373 in late December in the United States and Mexico.

Novavax recruited and randomized more than 16,000 participants in the Prevent-19 study. The company plans to complete its targeted recruitment of 30,000 patients in the first half of February. This is encouraging as there have been concerns about enrollment with two COVID-19 vaccines already available to many Americans.

How long could it be before NVX-CoV2373 can receive EUA in the United States? The Food and Drug Administration (FDA) requires that study participants be monitored for at least two months after they are fully vaccinated. The second dose of Novavax vaccine is given 21 days after the first dose. This means that the earliest biotechnology would be able to complete its analysis is probably in mid-March. Assuming all goes well, it’s possible NVX-CoV2373 could win the EUA from the FDA in April.

Is it time to buy?

With exciting news from Novavax, is it time to buy biotech stock? Or is it too late? I have long argued that Novavax was a good choice. I don’t think it’s too late to pick up stocks.

I fully expect Novavax to get clearances in the UK and then get clearances in other countries. The big price is the American market. Even though the federal government has added to its supply agreements with Pfizer and Moderna, I suspect that NVX-CoV2373 will still be on track to win the EUA if the results of the advanced Prevent-19 study are similar to the UK study by Novavax.

Signs indicate that COVID-19 is akin to seasonal flu, requiring annual vaccination. Assuming this is the case, Novavax could realistically generate annual sales of several billion dollars. It also has a promising influenza vaccine for regulatory submission in NanoFlu. The company is exploring the potential of combining its two main candidates in a combined COVID-19 / influenza vaccine. I think it could be a huge winner if successful.

One thing is clear, however, after Novovax’s announcement Thursday: Pfizer / BioNTech and Moderna are expected to have a formidable rival in the COVID-19 vaccine market soon.