Novavax study: Shot about 90% effective
Novavax, the fifth company to receive major 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 with the placebo.
Of the 77 trial participants infected with the coronavirus, 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. The study 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 coronavirus 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.
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 a month of NVXCOV2373 by the fall and 150 million doses a 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.
In the U.S., Novavax intends its vaccine to be used mainly 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.