Table of ContentsView AllTable of ContentsHow It WorksHow Effective Is It?When Was It Made Available?Who Can Get the Novavax Vaccine?Side Effects and Adverse EventsFunding and DevelopmentNext in COVID-19 Vaccine Brand GuideAn Overview of Pfizer’s COVID-19 Vaccine
Table of ContentsView All
View All
Table of Contents
How It Works
How Effective Is It?
When Was It Made Available?
Who Can Get the Novavax Vaccine?
Side Effects and Adverse Events
Funding and Development
Next in COVID-19 Vaccine Brand Guide
Novavax is a Maryland-based biotech company that has taken a traditional approach to developing a vaccine against COVID-19.
This put Novavax behind its competitors, but early results showed promise. The company announced the vaccine was 90% effective overall in the PREVENT-19 Phase 3 trial. And it was 100% effective against moderate and severe disease.
On August 19, 2022, the Food and Drug Administration (FDA) authorized the Novavax COVID-19 Vaccine, Adjuvanted for emergency use in individuals ages 12 and older.It is the first protein-based COVID-19 vaccine authorized in the U.S.
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The Novavax vaccine is a protein subunit vaccine. This type of technology has been used to produce other vaccines like the hepatitis B and HPV vaccines.
Novavax’s vaccine uses a custom-made spike protein that mimics the natural spike protein in the SARS-CoV-2 virus. While mRNA vaccines deliver the instructions for making a protein, a protein-based vaccine delivers the protein (or parts of a protein) itself.
Novavax has for years worked on developing its recombinant nanoparticle technology, and created the first COVID-19 vaccine using this method in the spring of 2020. By summer 2020, earlyclinical trialsshowed that the vaccine appeared to be safe, and more advanced trials entered the planning stage in the United States and other countries.
Novavax announced on June 14, 2021, that the vaccine was 90.4% effective in a preliminary analysis of data from its Phase 3 trial in the U.S. and Mexico. It was also 100% effective against moderate and severe disease. The trial was conducted when theAlpha variantB.1.1.7 was the predominant strain in the U.S.
Novavax Says Its COVID-19 Vaccine Is 90% Effective
The company also announced that the vaccine was 60% effective in a Phase 2b clinical trial in South Africa and included protection from the Beta variant B.1.351.A later study comparing three doses of the Novavax vaccine and three doses of an mRNA vaccine found that they produced similar immune responses against the Omicron variants BA.1 and BA.4/BA.5.
In Novavax’s trial, participants were not directly exposed to the virus, but instead researchers used a natural infection approach.This method was also used for the three COVID-19 vaccines that received approval or emergency use authorization (EUA) from the FDA.
Ask an Infectious Disease Expert: Will COVID-19 Vaccines Work Against New Variants?
Novavax’s vaccine candidate generated a lot of interest because early animal study data showed that it was highly effective at preventing replication of the coronavirus in nasal passages.It was an important development for COVID vaccines since it suggested that it may help reduce both infection and transmission rates.
Novavax’s vaccine also relies on an established delivery method and can be stored at standard refrigerator temperatures.The available mRNA vaccines have to be frozen for longer-term storage, so the Novavax vaccine may be a better option in settings with limited freezer capacity.
However, Novavax was behind its competitors when it came to clinical trials. Novavax had announced on June 14, 2021, that it completed enrollment of 2,248 adolescents in its Phase 3 trial in adolescents ages 12 to 17.In February 2022, the company reported that the vaccine demonstrated 82% clinical efficacy against the Delta variant and planned to seek FDA authorization for this age group. Then on August 19, 2022, the FDA authorized the Novavax vaccine for individuals ages 12 years and older.Novavax also expects to initiate additional studies in younger children.
The U.S. secured 3.2 million doses of Novavax’s COVID-19 vaccine in July 2022, and later ordered an additional 1.5 million doses in February 2023.
Throughout the development of their vaccine, Novavax has faced challenges and experienced significant delays due to manufacturing issues.Sciencemagazine reported that the company had sold some of its manufacturing facilities and had to rely on more contractors to manufacture many of its vaccines.There were also delays in receiving authorization, as the FDA needed to review changes made to Novavax’s manufacturing process.
To help provide protection against newer variants, Novavax began developing updated vaccines. In December 2021, Novavax began development of a vaccine targeting the Omicron variant. They began a Phase 3 clinical trial in May 2022 to study their vaccine candidates targeting the BA.1 and BA.5 Omicron subvariants.
In October 2023, the FDA authorized theirupdated vaccineformula designed to protect against the XBB.1.5 Omicron variant. For the 2024-2025 update, the formula was updated to target the JN.1 Omicron variant. The JN.1 variant is the parent of the KP.2 strain used in the 2024-2025 formulas for the Pfizer and Moderna vaccines.
As with the other authorized COVID-19 vaccines, updated vaccines are used for all doses and the original vaccines are no longer available.
COVID-19 Vaccines:Stay up to date on which vaccines are available, who can get them, and how safe they are.
The Novavax COVID-19 vaccine is available for everyone 12 years and older. For those who have not received any previous COVID-19 vaccines, it is given as a two-dose primary series, eight weeks apart.
If you have gotten a COVID-19 vaccine and your last dose was before September 2023, the Centers for Disease Control and Prevention (CDC) recommends getting one dose of any updated vaccine to stay up to date.
The Novavax vaccine is also authorized as an additional dose for people who are immunocompromised, given at least eight weeks after the most recent dose.It was previously available as a booster dose in limited situations for people 18 and over, but was made available for wider use when the FDA authorized the updated formula in 2023.
Adults who took part in Novavax’s Phase 3 trials were asked to record any local or systemic reactions after each dose of the vaccine.
The most commonly reported side effects were:
Injection site pain lasted less than three days and fatigue, headaches, or muscle pain lasted less than two days in the Phase 3 trials.
Although rare, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis were also reported in some people who received the Novavax vaccine.
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.
20 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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Dunkle LM, Kotloff KL, Gay CL, et al.Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.N Engl J Med. 2022;386(6):531-543. doi:10.1056/NEJMoa2116185
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Department of Health and Human Services.Biden-Harris Administration secures 3.2 million doses of Novavax COVID-19 vaccine.
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