By Jacqueline Howard and Nadia Kounang, CNN
After more than a year with two types of COVID-19 vaccines used in the United States, it will be reviewed through the U. S. Food and Drug Administration next week.
FDA vaccine advisers are scheduled to meet Tuesday to discuss Novavax’s coronavirus vaccine for the country.
Based on data included in a company briefing paper released Friday, an FDA review found that the overall efficacy of the vaccine was 90. 4% against mild, moderate or severe COVID-19 over a period of 21/2 months after the end of the series. a series of two doses. The paper notes that, in a number one analysis, vaccine efficacy was reduced to 78. 6% in adults aged 65 years and older.
These efficacy figures were collected before the appearance of the Omicron variant of the coronavirus. It’s not yet clear how long the ion lasts or to what extent the vaccine will oppose Omicron.
In an announcement published in December, the company reported that the vaccine showed “extensive cross-reactivity against Omicron and other circulating variants of a two-dose number one regimen, with responses that are higher after a third dose at six months. “
The Novavax vaccine, called NVX-CoV2373, is given in two doses 3 weeks apart for the number one vaccine.
Although most adverse reactions to the vaccine were mild to moderate and lasted for a few days, the FDA has described rare cases of myocarditis and pericarditis (inflammation of the central muscle and inflammation of the tissues surrounding the center) related to the vaccine.
“Several cases of myocarditis/pericarditis have been reported in temporal relation to the treatment of NVX-CoV2373, with myocarditis after COVID-19 mRNA vaccines, and raising considerations about causal dating with NVX-CoV2373,” the FDA data document states.
The paper describes six cases that occurred after vaccination with Novavax. Five men over the age of 16 to 67. Of the six cases, five were hospitalized but have since recovered.
An increased risk of myocarditis and pericarditis has been known in other people who have obtained the Pfizer/BioNTech and Moderna Covid-19 mRNA vaccines that are now used in the United States.
On one Friday, Novavax in particular addressed the issues of central inflammation: “We have learned that we can expect to see cases of background myocarditis in any database large enough, and that young men are at a higher risk. -specific viral infections. He said the rate of myocarditis in the vaccinated participants was similar to that in the placebo group.
The company added: “There is not enough evidence to identify a causal link. We will continue to monitor all adverse events, adding myocarditis and pericarditis. “
The maximum non-unusual adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle pain. Reactions were more reported in young participants in clinical trials of the vaccine.
In its backgcircularer, the FDA summarized: “The known benefits in vaccinated people over the age of 18 compared to placebo are the reduction of the risk of COVID-19 from mild to severe at least 7 days after the number one vaccination cycle.
At Tuesday’s meeting, members of the FDA’s Vaccine Advisory Committee will vote on the question: “Based on the totality of the available clinical evidence, do the benefits of the Novavax COVID-19 vaccine when administered in 2-dose series outweigh its dangers?for use on other people over the age of 18?”
In late 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 was the first country to grant emergency use authorization for the Novavax vaccine. Since then, it has been legal in the European Union, United Kingdom, Canada, South Korea, Australia, India, Philippines and New Zealand, among other countries.
Although most adults in the U. S. While the U. S. has been vaccinated against COVID-19, the company’s leader said he sees the Novavax vaccine as a possible option for booster doses, regardless of the type of vaccine administered for a person’s initial doses.
Novavax’s vaccine evolved as a protein subunit vaccine, a more classic type of generation than the mRNA used for the Moderna and Pfizer vaccines. Other examples of subunit vaccines are hepatitis B and pertussis vaccines.
“Our vaccine offers a differentiated option based on a well-understood protein-based vaccine platform that may be an option for the portfolio of vaccines available to help combat the Covid-19 pandemic,” Novavax CEO Stanley Erck said in a statement. . January.
Novavax’s protein-based coronavirus vaccine relies on what is known as the generation and adjuvant of Novavax recombinant nanoparticles, called Matrix-M, to stimulate an immune reaction and higher levels of neutralizing antibodies.
Protein-based vaccines like Novavax’s allow the body’s immune formula to recognize small, modified parts of the virus it targets. In the case of Novavax, these parts of the coronavirus spike protein.
When the genetic series of the virus that causes Covid-19 was published, scientists around the world temporarily knew about it as a coronavirus because of the “spike proteins” on its surface. These tips form giant bumps, giving coronaviruses the appearance of crowned dresses. and “corona” is the Latin word for “crown. “
Novavax scientists knew the spike protein gene and created a modified edition of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then inflamed the moth cells, the fall armyworm cells, which led them to produce the coronavirus spike protein.
These virus-like nanoparticles collected to make the Novavax vaccine.
“The very concept of the vaccine is to show the immune formula, anything that looks, tastes and acts like a virus, that doesn’t make you sick. So we made the spike protein. We put it in a particle, basically, like a soap bubble, and that’s the duration of the virus,” Dr. Gregory Glenn, Novavax’s president of studies and development, told CNN last year.
“It’s not contagious. We never touched the coronavirus itself,” Glenn added. “It’s then given to people and they produce an immune reaction that focuses only on the peak, and I would say the hallmark of our vaccine is that it provides a very strong immune reaction with very few side effects, and the dose is very low and the vaccine can be stored at general refrigeration temperatures.
While Novavax has an emergency use authorization for its NVX-CoV2373 vaccine, it is also reading a separate vaccine that particularly targets the Omicron variant, called NVX-CoV2515. The company announced this week that it has begun a phase 3 trial of the vaccine, comparing its protection and efficacy as a booster.
“The trial will also look for antibody responses to a bivalent vaccine, containing NVX-CoV2373 and NVX-CoV2515, given to participants who have won a series of boosters of an mRNA vaccine,” Novavax said in a news release.
The trial will look at the Omicron-specific vaccine and a bivalent vaccine in more than 1000 participants in Australia.
Two doses of Omicron-specific vaccine or the original NVX-CoV2373 vaccine will be administered after 3 doses of the Pfizer-BioNTech and/or Moderna vaccines that have been won at least 3 months before participants enroll in the trial.
Similarly, two doses of Omicron-specific vaccine or NVX-CoV2373 will be given after two doses of either mRNA vaccine are won at least six months before joining the trial.
Two doses of bivalent vaccine will be given to participants vaccinated with 3 doses of mRNA vaccine at least 3 months before joining the trial.
The trial will last about 10 months and the first effects are expected in the remainder of this year.
El-CNN-Wire™
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