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The Food and Drug Administration (FDA) today authorized Novavax’s two-dose COVID-19 vaccine after several weeks of evaluation for its safety and effectiveness.
Novavax is a late entrant to the US vaccine program. If the Centers for Disease Control and Prevention signs off on the vaccine, it will be the fourth COVID-19 vaccine available to people in the U.S.
The Novavax vaccine uses a protein-based technology that is more traditional than the new mRNA technology used by Pfizer and Moderna.
More than 71% of Americans older than 5 years are fully vaccinated.
However, in June, an FDA advisory panel determined that Novavax offers an option for people who are hesitant to get an mRNA vaccine, such as that of Pfizer or Moderna, or Johnson & Johnson’s vaccine.
Will Novavax work against Omicron?
The company presented data showing that the vaccine has an efficacy of about 90.4%. The findings come from two large clinical studies conducted in 2021 and involving around 44,000 people.
Notably, none of these studies were conducted while Omicron was circulating in the US
Novavax said it is developing a booster vaccine tailored to the Omicron BA.1 subvariant and that doses could be available by the end of the year. Together, the company will redouble research on vaccines targeting the BA.4 and BA.5 subvariants.
Novavax appears to be safe and effective
The Novavax vaccine, called NVX-CoV2373 is already authorized in more than 12 countries and by the European Commission and the World Health Organization.
The two-dose regimen consists of two half-milliliter doses given 21 days apart.
In a phase 3 clinical trial in the US and Mexico, the company found that two doses of the vaccine provide 90.4% protection against infection and 100% efficacy against moderate and severe cases of COVID-19.
A second phase 3 clinical trial involving more than 14,000 participants in the UK found it to be 89.7% effective.
Data in both trials were collected prior to ramp-up with Omicron. The company has not yet collected data on how its vaccine reacts against Omicron.
The company reported mostly mild to moderate side effects that resolved within a day or two. The most common were injection site tenderness, headache, nausea, muscle pain, joint stiffness, and fatigue.
In the larger phase 3 clinical study, there were no cases of severe allergic reactions, vaccine-induced thromboses, or Guillain-Barre syndrome.
Out of 40,000 participants, there were six cases of myocarditis and pericarditis. Representatives from Novavax said that this number is consistent with the rate of myocarditis in the general population and that there is not enough evidence to show that the vaccines caused the rare forms of heart inflammation.
While some of the FDA panelists said more data should be collected on the link between the vaccine and myocarditis, they determined that the benefits outweighed the risks of vaccination overall.
What is a protein-based vaccine?
When COVID-19 first appeared, Novavax scientists isolated the virus’s protein and created a modified version of it.
Unlike other licensed vaccines, which deliver genetic material to direct the production of proteins by cells, the Novavax vaccine delivers proteins directly. The antigen in the vaccine cannot replicate or cause COVID-19.
Types of vaccines for COVID-19
There are four main types of COVID-19 vaccines in development: mRNA, vector, protein subunit, and inactivated whole virus vaccines.
mRNA vaccines from Pfizer and Moderna were the first to be approved by the FDA. Johnson & Johnson’s adenovirus vector vaccine is also licensed in the US
This approach, called recombinant nanoparticle technology, is more traditional for vaccine development compared to the newer mRNA and adenovirus vector technologies.
Recombinant protein subunit technology has been used safely for decades.
For example, the hepatitis B vaccine, licensed in 1986, is recommended for all newborn babies in the US. Human papillomavirus vaccines have been crucial in minimizing cervical cancer since 2006.
Novavax did not present data on the effects if it was mixed with other types of vaccines against COVID-19.
The company is also testing its formulation in teenagers and has submitted to the FDA its existing data on the vaccine’s safety and efficacy in people ages 12 to 18.
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