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Maryland-based biotech company Novavax said Monday that its experimental Covid-19 vaccine is 100 percent safe and effective against moderate to severe disease.
Results are from the company’s Phase 3 clinical trials conducted in the United States and Mexico. The company has already completed a Phase 3 trial in the UK, but results from US trials are required to apply for emergency use authorization in that country.
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Novavax said in a statement that it plans to file an application with the Food and Drug Administration for authorization in the third quarter. That would add a fourth vaccine to the United States’ arsenal.
It is not clear what role the company’s vaccine will play in the US vaccination effort. The Biden administration has already secured sufficient doses of the three currently available vaccines to vaccinate the US population.
Moreover, vaccine uptake in the US has slowed in recent weeks, weakening the need for additional Covid-19 vaccines, at least in this country.
But other parts of the world remain vulnerable and in dire need of doses. President Joe Biden and other leaders at the G7 summit at the weekend pledged to donate one billion doses of vaccine to low-income countries.
“We need more manufacturers to produce 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.”
Dr. David Hirschwerk, an infectious disease specialist at Northwell Health System in Manhasset, New York, agrees. “The more ways we have in dealing with this virus, the more ways we have in providing protection to people, the better off we will be,” he said.
Novavax is given in two doses, 21 days apart. The company said in a statement that the Phase 3 trial involved nearly 30,000 participants in the United States and Mexico, and included underrepresented minority groups, as well as populations at risk of contracting Covid-19.
By the end of the trial, there were 77 cases of Covid-19: 63 in the placebo group and 14 in the vaccine group, for an overall efficacy of 90 percent, the company said. All cases in the vaccine group were mild, meaning the vaccine was 100 percent effective against moderate to severe disease. (The company’s results were presented in a press release and still have to be submitted for peer review.)
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Novavax said the vaccine was 93 percent effective against what the Centers for Disease Control and Prevention identified as variables of concern or variables of concern, including an alpha variant, or B.1.1.7, which was first found in the kingdom. United States, which was the dominant variable seen in the United States experience.
Variants first identified in Brazil, South Africa, and India also account for a small proportion of cases.
The initial results were promising, said Robert Wood Johnson Foundation executive vice president Dr. Julie Morita, a former health commissioner for the Chicago Department of Public Health.
“If the efficacy results ultimately look as good as they are in the press release, that indicates that the vaccine is very effective against variants,” Morita said.
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Novavax was one of five drugmakers to receive funding from the Trump administration’s Operation Warp Speed, an initiative to develop Covid-19 vaccines. Novavax will be the third Operation Warp Speed candidate to get the green light from the Food and Drug Administration, along with Moderna and Johnson & Johnson. (Pfizer-BioNTech has not received program funding for its vaccine.)
Novavax is slightly different from other vaccines used. All Pfizer, Moderna and Johnson & Johnson vaccines work by providing the body’s genetic instructions to build the coronavirus spike protein, which the immune system learns to recognize and fight. The Novavax dose skips directions and delivers Spike Protein directly into the body.
Many known vaccines use a similar approach — delivering a specific part of the pathogen into the body to learn to identify it — including the hepatitis B vaccine, the human papillomavirus vaccine, and the shingles vaccine. Novavax vaccine can be stored at standard refrigerator temperatures.
As of Sunday, more than 143 million people in the United States have been fully vaccinated, according to the CDC.
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