Novavax vaccine over 90% effective in protecting against COVID-19 infection, study shows
Novavax, the fifth company to receive large federal support for its COVID-19 vaccine, is as good as its competitors, according to data the company released Monday.
The vaccine is more than 90% effective in protecting against infection and even more protective against some of the variants, according to the trial of 29,960 volunteers in the U.S. and Mexico. No one who received the active vaccine fell seriously ill.
Twice as many volunteers received the active vaccine compared to the placebo.
Of the 77 trial participants infected with COVID-19, 63 were in the placebo group and only 14 had received the active vaccine, according to the Gaithersburg, Maryland-based biotechnology firm.
More than 80% of participants who became infected had one of the viral variants, genetic sequencing showed. Most of them had the alpha variant first seen in the United Kingdom, which was spreading across the United States during the trial, which ran from late January to late April.
The vaccine, called NVX-CoV2373, also appeared effective among people over 65, those with medical conditions that put them at high risk or those with frequent COVID-19 exposures. About 13% of participants were over 65, 20% were Latin American, 12% were African American, 7% were Native American and 5% were Asian.
As with other vaccines, common side effects included tenderness and pain around the injection site, muscle aches, headaches, and fatigue.
“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Novavax’ president and CEO Stanley Erck said in a statement Monday. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”
The company expects to request federal authorization for its vaccine this summer after it completes final chemistry, manufacturing, and control requirements.
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Novavax took longer to prove the safety and effectiveness of its vaccine in part because the company is much smaller than other vaccine-makers. It had only about 40 employees when the pandemic began and has struggled to ramp up production, Erck told USA TODAY last month.
Assuming its vaccine is authorized for use, Novavax expects to produce 100 million doses per month of NVX-CoV2373 by the fall and 150 million doses per month before the end of the year.
The company continues to study its vaccine in 2,248 volunteers ages 12 to 17.
Three other COVID-19 vaccines have been authorized for use by the U.S. Food and Drug Administration. Vaccines from Pfizer-BioNTech and Moderna require two shots apiece and are made with a technology known as messenger RNA, which turns the body’s cells into factories producing bits of protein found on the surface of the virus that causes COVID-19. This teaches the immune system to respond when infected.
Pfizer and its German partner BioNTech did not receive federal funding to develop their vaccine, but did get nearly $2 billion to support its manufacturing and distribution. Moderna received about $2.5 billion, which included support for development as well as manufacturing and distribution of its first 100 million doses.
A vaccine made by Johnson & Johnson, which received nearly $1.5 billion from taxpayers for its first 100 million doses, requires only one dose and uses a harmless cold virus to deliver the same type of protein.
The government has now bought 300 million doses each of the Pfizer-BioNTech and Moderna vaccines, and 200 million of the J&J vaccine. So far, 169 million doses of Pfizer-BioNTech, 129 million doses of the Moderna shots and 11.5 million doses of J&J have been administered nationwide.
The Novavax vaccine, which was supported with $1.6 billion in federal funds for its first 100 million doses, is based on a third type of vaccine technology in which the protein antigen is delivered directly into the body inside tiny particles. It is combined with a booster that enhances the body’s immune response.
A fifth vaccine, made by AstraZeneca in collaboration with Oxford University, has been approved for use around the world and shown to be effective against several strains of the virus. The government spent $1.2 billion to pre-buy 300 million doses of this vaccine, but the collaborators have not applied for use in the United States, likely because American needs were already met by the first three vaccines to win approval.
Related: Pfizer COVID-19 vaccine for younger kids on track, with shots to come in the fall, company says
In the U.S., Novavax intends its vaccine to mainly be used to provide booster shots if they become necessary, Erck said. Many parts of the world are still desperately in need of initial vaccine doses.
None of these vaccines includes the whole virus, so they cannot cause COVID-19 and they are not made in eggs, so they do not pose any risk to people who have egg allergies, although people who are allergic to a vaccine’s ingredients have been warned not to get those particular shots.
Contact Karen Weintraub at [email protected]
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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