By Sara G. Miller and Erika Edwards - NBC News
Maryland-based biotech company Novavax reported Monday that its experimental COVID-19 vaccine is safe and 100% effective against moderate and severe cases.
The results come from phase 3 clinical trials conducted by the company in the United States and Mexico.
The company has already completed a phase 3 trial in the UK, but the results of the US trial are required to apply for authorization for emergency use in this country.
Novavax said in a statement that it plans to apply for authorization from the Food and Drug Administration (FDA) in the third quarter of this year.
This would add a fourth vaccine to the American arsenal.
Dr. Stephaun Wallace receives his second injection from Dr. Tia Babu during the phase 3 clinical trial of Novavax's Covid-19 vaccine at the UW Virology Research Clinic in Seattle on February 12.
Karen Ducey Archive / Getty Images via NBC News.
It's unclear what role the company's vaccine would play in America's vaccination efforts.
The Biden Administration has already secured enough doses of the three vaccines currently available to vaccinate the American population.
Additionally, vaccine delivery in the US has slowed in recent weeks, further weakening the need for more COVID-19 vaccines, at least in this country.
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But other parts of the world remain vulnerable and in dire need of doses.
President Joe Biden and other leaders pledged at the Group of Seven (G-7) summit this weekend to donate 1 billion doses of vaccines to lower-income countries.
"We need more manufacturers to make more vaccines," said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee.
"The global need for them is enormous," he added.
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Dr. David Hirschwerk, an infectious disease specialist at Northwell Health System in Manhasset, New York, agreed with him.
"The more ways we have to get to this virus, and the more ways we have to provide protection to people, the better we are," he said.
The Novavax vaccine is given in two doses, 21 days apart.
The phase 3 trial had about 30,000 participants in the US and Mexico, and included underrepresented minority groups, as well as populations at high risk for COVID-19, the company said in a statement.
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At the end of the trial, there were 77 cases of COVID-19: 63 in the placebo group and 14 in the vaccine group, with an overall efficacy of 90%, according to the company.
All cases in the vaccine group were mild, meaning that the vaccine was 100% effective against moderate to severe disease.
(The company's results were presented in a press release and have yet to undergo expert review.)
Novavax said the vaccine was 93% effective against what the Centers for Disease Control and Prevention (CDC) have defined as variants of concern or variants of concern, including the Alpha variant, or B.1.1.7 , first found in the UK, which was the predominant variant observed in the US trial.
Variants first identified in Brazil, South Africa, and India also accounted for a small proportion of cases.
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Robert Wood Johnson Foundation Executive Vice President Dr. Julie Morita, a former health commissioner for the Chicago Department of Public Health, said the preliminary results were promising.
"If the efficacy results are ultimately as good as the press release, that would suggest that the vaccine is quite effective against the variants," Morita said.
Novavax was one of five drug makers to receive funding from the Trump Administration's Operation Warp Speed, an initiative to develop vaccines against the coronavirus.
Novavax's vaccine would be the third Operation Warp Speed candidate to get a green light from the FDA, along with Moderna and Johnson & Johnson.
(Pfizer-BioNTech did not obtain program funding for its vaccine.)
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The Novavax vaccine differs slightly from the other vaccines in use.
The Pfizer, Moderna and Johnson & Johnson vaccines work by providing genetic instructions for the body to build the coronavirus spike protein, which the immune system learns to recognize and fight.
The Novavax vaccine bypasses the instructions and delivers the spike protein directly to the body.
Many known vaccines use a similar approach — delivering a specific part of the pathogen to the body so it learns to recognize it — including the hepatitis B vaccine, the HPV vaccine, and the shingles vaccine.
Novavax vaccine can be stored at normal refrigerator temperatures.
As of Sunday, more than 143 million people in the US had been fully vaccinated, according to the CDC.
