These efficacy figures were collected before the emergence of the Omicron coronavirus variant. It is still unclear how long the protection lasts or how well the vaccine will protect against Omicron.
Novavax’s vaccine, called NVX-CoV2373, is given in two doses three weeks apart for the primary series.
Although most adverse reactions to the vaccine were mild to moderate and lasted only a few days, the FDA has described rare events of myocarditis and pericarditis – inflammation of the heart muscle and inflammation of the tissues surrounding the heart – associated with the vaccine.
“Several myocarditis/pericarditis events have been reported temporally related to NVX-CoV2373 administration, similar to myocarditis following COVID-19 mRNA vaccines and raising concerns about a causal relationship with NVX-CoV2373,” says the FDA information document.
The document describes six cases that occurred after vaccination with Novavax. Five concerned men aged 16 to 67. Of the six cases, five were hospitalized but have since recovered.
An increased risk of myocarditis and pericarditis has been identified in people who received the Pfizer/BioNTech and Moderna Covid-19 mRNA vaccines now used in the United States.
The company added: “We believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.”
The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle aches. Reactions were reported more frequently in younger participants in clinical trials of the vaccine.
In its briefing document, the FDA summarized, “The known benefits in vaccinees 18 years of age and older over placebo are reduced risk of mild to severe COVID-19 occurring at least 7 days after the second round. primary vaccinations.
At Tuesday’s meeting, members of the FDA’s Vaccine Advisory Committee will vote on the issue: “Based on the totality of available scientific evidence, the benefits of the Novavax COVID-19 vaccine when given serially of 2 doses outweigh its risks for use in people aged 18 and over?”
“We believe our vaccine offers a differentiated option”
At the end of January, Novavax announced that it had submitted an application to the FDA to authorize its coronavirus vaccine for emergency use in the United States.
In November, Indonesia became the first country to grant emergency use authorization for Novavax’s vaccine. It has since been licensed in the European Union, United Kingdom, Canada, South Korea, Australia, India, Philippines, and New Zealand, among other countries.
Even though most adults in the United States have been vaccinated against Covid-19, the company’s chief said he considers Novavax’s vaccine as a potential option for booster doses, regardless of the type of vaccine given for a person’s initial doses.
Novavax’s protein-based coronavirus vaccine relies on what’s called recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.
Protein-based vaccines like Novavax’s allow the body’s immune system to recognize small, modified pieces of the virus it is targeting. In the case of Novavax, that means pieces of the coronavirus spike protein.
Novavax scientists identified the gene for the spike protein and created a modified version of this gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells – specifically Fall Armyworm cells – tricking them into producing the coronavirus spike protein.
These virus-like nanoparticles were harvested to make Novavax’s vaccine.
“It’s not contagious. We never touch the coronavirus itself,” Glenn added. “Then that is given to people, and they produce an immune response that is just focused on the spike – and I would say the hallmark of our vaccine is that it gives a very strong immune response with very little effect. side effects, and the dose is very low and the vaccine can be stored at normal refrigerated temperatures.”
Novavax begins phase 3 trial of Omicron-specific booster
“The trial will also seek to determine antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, given to participants who received a booster series of an mRNA vaccine,” Novavax said. in a press release.
The trial will analyze the Omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.
Two doses of the Omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.
Similarly, two doses of the Omicron-specific vaccine or original NVX-CoV2373 will be given after two doses of either mRNA vaccine received at least six months prior to joining the trial.
Two doses of the bivalent vaccine will be given to participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.
The trial will last around 10 months and the first results are expected in the second half of this year.