Novavax’s trial included 29,960 participants across 119 locations in the United States and Mexico, according to a company statement. Half of the participants received the vaccine, while the other half got a placebo dose.And 77 cases of coronavirus infection appeared during the experiment: 63 cases in the placebo group and 14 cases in the vaccine group. It was found that all cases in the group that received the vaccine were mild, while 10 moderate cases and four severe cases were observed in the placebo group.
On a call with investors, Novavax representatives noted that six additional people in the placebo group required hospitalization during the trial, and one of those individuals died, STAT News reported.However, positive COVID-19 test results for these individuals were not confirmed in the trial’s central laboratory, so they were not included in the efficacy analysis.
Based on the data provided so far, the Novavax vaccine appears to be 100% effective against moderate to severe COVID-19 infections and 90.4% effective against occasional infections, the company said.
Specifically, the vaccine was 91% effective in protecting against symptomatic infection among high-risk individuals — those with existing medical conditions that increase the risk of severe infection, and those at high risk of infection who are over 65 years old.
“It’s a strong finding,” University of Florida biostatistician Natalie Dean told the New York Times. “It puts them that high.”
The company has not yet released the full experimental data, and plans to do so at a future date, as the company’s statement explains: “Further analyzes of the experiment are ongoing and will be shared across prepress servers as well as submitted to scientific journals for publication.”
In a press release issued Monday, Novavax also explained that the vaccine protects against 93% of “variables of concern” (VOC) and “variables of interest” (VOI). Volatile organic compounds (VOCs) are defined as copies of a virus with increased transmissibility, disease severity, or the ability to thwart vaccines or treatments, according to the Centers for Disease Control and Prevention (CDC); VOIs carry genetic variations that can cause changes in transmissibility and disease severity, but mutations still show a limited prevalence.
The company looked for volatile organic compounds and VOIs by analyzing the genetic material of the virus in 54 of the 77 cases of “Covid-19”. Of the 77 cases, 35 were related to VOCs and nine were related to VOIs.
STAT News reported that about half of the participants with VOCs were infected with the alpha variant, also known as B.1.1.7.
The New York Times revealed that Novavax will apply for an Emergency Use Authorization (EUA) in the US after quality control testing is completed, to demonstrate that doses can be reliably produced on large scales. Stanley Erk, chief executive of Novavax, said in an interview that the company also plans to apply for a license in Britain, the European Union, India and South Korea, and is likely to get permission in one of those countries before that happens in the United States.
The vaccine, called NVX-CoV2373, contains nanoparticles studded with modified barbed proteins – proteins that stick to the coronavirus and attach to cells to stimulate infection, according to Live Science. The nanoparticles cannot replicate like a virus or cause Covid-19, but instead train the immune system to recognize SARS-CoV-2, the virus that causes the disease.
The vaccine also contains saponins, which are compounds extracted from the soapbark tree that act as an adjuvant, meaning they summon additional immune cells to the vaccination site, the New York Times reported. Doses can be stored at refrigerator temperatures and given in two doses, three weeks apart, according to STAT.