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Later this year, a fourth COVID-19 vaccine may be available in the United States.
Novavax reported on Monday that its two-dose regimen proved to be very effective and safe in late-stage clinical trials. The biotechnology company plans to seek authorization from the U.S. Food and Drug Administration in the third quarter.
During the Phase 3 study, it was found that the overall effective rate of the vaccine was 90%, and the effective rate against moderate and severe coronavirus infections was 100%. It is also 93% effective for the variants of interest, CDC defined, And is 100% effective for other variants.
The most common side effect is mild to moderate pain and tenderness at the injection site that lasts less than three days. Fatigue, headaches, and muscle pain that last less than two days are also common.
The result is in the U.S. and other G7 countries Seeking to distribute more COVID-19 vaccines to developing countries As part of efforts to end the global pandemic.
“Novavax continues to work with a sense of urgency to complete our regulatory submissions and provide this vaccine to the world that still needs vaccines,” Novavax CEO Stanley C. Erck Say.
Novavax expects to produce 100 million doses of vaccine per month by the end of the third quarter and 150 million doses of vaccine per month by the end of this year.
The Phase 3 trial recruited nearly 30,000 adult volunteers at 119 locations in the United States and Mexico, and two-thirds of the participants received two injections of the vaccine every three weeks.
Among the 77 study participants infected with COVID-19, only 14 cases were observed in the vaccinated group. All these cases are defined as mild. 14 moderate or severe cases were observed in volunteers who received placebo.
It was also found that the vaccine is 91% effective in preventing diseases in high-risk groups-defined as 65 years of age and elderly and young people with underlying health conditions.
Novavax officials said they will share more test data once the test is available.
Compared with vaccines produced by Pfizer and Moderna, the vaccine uses more traditional techniques to trigger an immune response. Rely on synthetic messenger RNAIt contains full-length spike protein mixed with adjuvant to enhance immune response. The protein neither causes COVID-19 nor replicates.
The vaccine also does not have any special storage requirements that may complicate distribution.
Novavax’s third phase trial Since last DecemberIt aims to include a diverse research population, with adults aged 65 and over accounting for at least 25% of volunteers, and black volunteers for at least 15%.
The company is currently testing its vaccine in 2,200 adolescents aged 12-17.
If emergency use authorization is obtained, Novavax will join Pfizer, Moderna, and Johnson & Johnson to become the four COVID-19 vaccines available in the United States. This is one of six vaccines that the United States has invested in as part of Operation Distortion Speed.
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