Novavax, Inc. ($NVAX) has been one of the biggest pioneers on the pharmaceutical market since the outbreak of the COVID-19 pandemic. This is mainly due to the extreme increase that the NVAX share has seen this year, by growing with a sensational 2000%. As several biotech companies have begun phase 3 clinical trials for an effective vaccine, it’s slowly becoming clear which pharmaceutical companies and vaccine candidates are lagging behind. The question that remains is where Novavax is located.

It seems only a matter of time before a COVID-19 vaccine is approved by the FDA. There is still a Phase 4: this is the examination after registration and related to the indication area for which the drug has been registered. These studies are not necessary for registration purposes, but they are important for optimizing the use of the medicine. This means that the biggest step has been taken after Phase 3 has been completed. Let’s find out if this is one of the reasons Novavax can count on optimism from shareholders and various analysts.

Novavax has a flu vaccine that goes through the Phase 3 studies called NanoFlu. Novavax is expected to file an application with the FDA before the end of this year. This is not directly related to the COVID-19 vaccine race, but it has several interfaces and at the same time shows that more is in the pipeline of the American company.

Back to the vaccine candidate that Novavax is producing. The start of the Phase 2 portion of its Phase 1/2 clinical trial with the Covid-19 vaccine was previously announced on August 24. The aim of the study is to evaluate the immunogenicity and safety of the NVX-CoV2373 vaccine. This means that it knows various competitors who are further along in the vaccine race. Novavax President Gregory Glenn expects the Phase 2 portion of the study to be an extension of the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373. The Phase 2 results allow the use of the vaccine through the EUA during the phase 3 study.

Why the company has a good starting position is mainly due to the government funds they have received. Earlier this year, the government gave $1.6 billion to develop an effective vaccine. The aim is to have 100 million doses available at the end of the line. Novavax then shortly after entered into an agreement with the government of Canada to provide 76 million doses of the vaccine to this country as well. This agreement is likely to be finalized in the second quarter of 2021 and is subject to Health Canada’s approval.

Furthermore, attention is paid in the media to the non-conventional approach that the company uses. The possibilities of a subunit vaccine are being examined by Novavax. Rather than the whole microbe, a subunit vaccine presents antigens that best stimulate the immune response to the immune system. One production method involves isolating the specific protein from the virus and administering it independently. Subunit vaccines contain only the necessary antigens and not all the other molecules that make up the microbes. As a result the potential for side effects from the vaccine is very small.

Sounds like a promising remedy so far. The other advantages of the method are that it can be applicable to people with a weakened immune system, it allows for long-term immunity and it is relatively safe because the vaccine contains only a part of the virus. Disadvantages are low immunogenicity or the ability to elicit an immune response, therefore subunits may require adjuvants to catalyze a stronger response. In addition, multiple doses of the vaccine are required for long-term immunity. Several doctors still have questions about the side effects, as adjuvanted vaccines have been shown to have more local and systemic reactions. Novavax differs from the competition with the characteristics as mentioned above, which might be an advantage for the shareholders.

A different method than most pharmaceutical companies means that Novavax can be seen as an adventurer. It’s therefore a share that is suitable for those who believe in the words: “high risk, high reward“. The company has previously worked with other international pharmaceutical companies such as Takeda Pharmaceutical ($TAK) and the Serum Institute of India to develop a COVID-19 vaccine. With the various international partnerships, Novavax seems to be responding intelligently to the necessary worldwide production capacity. With this strategy it seems possible to realize a vaccine production in other parts of the world more efficiently and fast. On Wall Street, analysts are still optimistic about the future value of the company. For now it is important that the company continues to update the market and its shareholders frequently, as it won’t fall in the shadow of other major pharmaceutical companies such as AstraZeneca, Pfizer and Johnson & Johnson.

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