Novavax’s Protein COVID-19 Vaccine Now Available in Europe
Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine has been authorized for distribution in the European Union (E.U.), making it the fifth COVID vaccine available for use in the E.U. Approved for people over 18 years old, Nuvaxoid is the first protein subunit COVID vaccine to be approved for use.1 2 The vaccine contains the coronavirus spike protein made by using an insect virus (baculovirus) and insect cells plus an adjuvant (saponin) extracted from tree bark.3
The recombinant technology Novavax used to make its COVID vaccine is more traditional, similar to the recombinant hepatitis B vaccine and protein subunit acellular pertussis vaccine.
The two recommended COVID vaccine doses given three weeks apart contain a protein “subunit” which has purified fragments of COVID using recombinant nanotechnology4 along with a soapbox tree adjuvant (Matrix-M), which is supposed to create a strong immune response in the recipient.5 This is distinct from the Pfizer/BioNTech and Moderna/NIAID COVID shots, which use mRNA technology to inject synthetic mRNA into the body to provoke cells to produce the SARS-CoV-2 spike protein, which is designed to stimulate antibody production.6
The Johnson & Johnson/Janssen and AstraZeneca/Oxford University COVID vaccines rely on viral vector technology.7
Novavax COVID Vaccine May Be Accepted by Those Skeptical of mRNA Technology
Some analysts expect that Nuvaxovid will be more appealing to people who are skeptical about the safety of the new mRNA technology used to create the Pfizer and Moderna COVID vaccines. According to virologist Angela Rasmussen, PhD:
I’ve talked to some unvaccinated folks here in Canada and the U.S. who stated they’d reconsider their position if a more “traditional” (not mRNA or viral vectored) vaccine were available.8
Other factors that might make Nuvaxovid more marketable are that it is less expensive to manufacture compared to mRNA vaccines and it does not require storage in freezing temperatures.9
The European Medicines Agency (EMA) approved NVX-CoV2373 after clinical trials involving more than 45,000 adults concluded the vaccine effectively prevented SARS-CoV-2 virus infections. A study in the United Kingdom found the vaccine 89.7 percent effective and a study in Mexico found the vaccine 90.4 percent effective at preventing SARS-CoV-2 infections.10
FDA Has Not Approved Novavax COVID Vaccine
The NVX-CoV2373 vaccine was only granted conditional marketing authorization and the E.U.’s executive commission must confirm the approval prior to the vaccine being distributed to the public. The World Health Organization (WHO) already approved Novavax for emergency use in the United Nations (UN) COVID-19 vaccine program which allows poorer countries to receive the vaccine.11 In November, the vaccine was approved for use in Indonesia and the Philippines. Novavax has applied for licensing in Australia, Canada, Indonesia, New Zealand and the U.K.12
Despite being a U.S.-based company, Novavax does not have Food and Drug Administration (FDA) approval for Nuvaxoid to be distributed in the U.S.13 The vaccine has not yet been tested for efficacy against the Omicron variant of the SARS-CoV-2 virus, but Novavax stated that should the current vaccine not be a match, they plan on developing a version of the vaccine that would be effective against Omicron.
The E.U. has ordered 100 million doses of the vaccine in anticipation of the EMA’s approval.14 On Jan. 10, 2022, Novavax’s president and CEO Stanley Erck announced that shipments of their vaccine to the E.U. had begun. He characterized the move as a “big milestone for the company” and noted, “There is a lot of pent-up demand for our vaccine.”15
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