Novavax, a Maryland-based biotech company, has reported that its COVID-19 vaccine is safe and effective against moderate to severe COVID cases. The results are based on recently concluded Phase 3 clinical trials in the US and Mexico.
Novavax Phase 3 Results
Novavax announced that NVX-CoV2373, the recombinant nanoparticle protein-based COVID vaccine, has demonstrated an overall 100% protection against moderate to severe cases and more than 90% overall efficacy.
The study included more than 29,000 participants across 119 sites in both the US and Mexico to evaluate the vaccine's efficacy, safety, and immunogenicity while emphasizing the recruitment of representatives of communities and demographic groups highly impacted by COVID-19, according to Novavax.
Some side effects in the trials included fatigue, headache, muscle pain, and generally milk, with a small percentage of participants experiencing worse side effects. Despite this, Novavax remains scheduled to produce 100 million doses per month by the end of the third quarter and over 150 million doses per month in this year's fourth quarter Reuters reports.
Stanley Erck, the President, and Chief Executive Officer, said that Novavax is a step closer to addressing the persistent global public health needs for more COVID-19 vaccines available in the market. The clinical results reinforce the effectiveness, and overall protection of NVX-CoV2373 provides for moderate and severe COVID cases.
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Next Step for Novavax
Novavax has already completed Phase 3 trials of their COVID-19 vaccines in the UK; however, as NBC News reports, phase 3 trials in the US are needed for the company to apply for emergency use authorization in the country.
In the statement, Novavax says it intends to apply to the US FDA for authorization in the third quarter of this year. This would add a fourth vaccine to the US's arsenal of COVID vaccines.
However, the current administration has already procured enough doses of the 3 vaccines currently available for emergency us to vaccinate the entirety of the US population, with vaccine uptake slowing down in recent weeks, further weakening the need for any additional COVID-19 vaccines.
Despite Novavax vaccines aren't likely to be used as a frontline defense in the US, the company says that it could be used in the following months or years. Erck says that the company believes that its vaccines can become a vital booster vaccine specifically in the US.
Other parts of the globe remain vulnerable and in urgent need of vaccines. The current administration, along with other world leaders, have pledged during the Group of Seven Summit to donate vaccines to lower-income countries in an effort to achieve global immunity in the soonest possible time.
Erck says that it is highly likely that the first doses of the Novavax vaccine would go to low- and middle-income countries.
Dr. William Schaffner, an expert in infectious diseases at Vanderbilt University Medical Center, Nashville, says that the country still needs more manufacturers to produce more COVID-19 vaccines, with the global need is still skyrocketing.
The Novavax vaccine is a two-dose vaccine to be administered 21 days apart.
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