FDA Advisors Support Novavax Covid-19 Vaccine Authorization

Novavax to seek authorization for COVID-19 vaccine 0:44 (CNN) — Vaccine advisers to the US Food and Drug Administration (FDA) decided Tuesday that it was beneficial Authorize Novavax’s COVID-19 vaccine, which uses a different technology than the three vaccines currently in use in the US, for emergency use in adults.
A majority of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor in response to the question of whether the benefits of the Novavax vaccine, administered in a two-dose initial vaccination regimen, outweigh its risks in people aged 18 years or older, based on available evidence. Twenty-one members voted in favor, one abstained and none voted against. If the FDA fully approves the vaccine, it will become the fourth licensed COVID-19 vaccine in the United States. The Novavax vaccine is made using small, laboratory-made pieces of the coronavirus to stimulate immunity. This protein-based approach is more traditional for vaccine development than the Pfizer/BioNTech and Moderna mRNA vaccines. Committee member Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine, said he sees the vote as an opportunity. “This is a different technology. It’s a more traditional protein-based vaccine,” Portnoy said. “The vaccine deserves the opportunity to be administered and studied.” “Certainly, the benefits outweigh the risks for an initial dose,” committee member Dr. Michael Nelson, chief of the division of asthma, allergy and clinical immunology at the University of Virginia School of Medicine, said of the vote. “I think this group fully recognized that this is probably a three-dose series and then data will have to be collected to support the need for booster doses and subsequent doses to make it probably a three-dose vaccine,” he said, hinting at how discussions could continue for the vaccine to be used as a booster shot. Ahead of Tuesday’s meeting, an FDA briefing document revealed that while most adverse reactions to the vaccine were mild to moderate and lasted only a few days, myocarditis and pericarditis (inflammation of the heart muscle and inflammation of the tissue surrounding the heart) occurred in six people after vaccination. In five of them, the inflammation arose within two weeks of receiving the vaccine. In one person, it occurred 28 days later. The cases were similar to myocarditis following mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, and raise “causal concern” with the Novavax vaccine, according to the FDA document. Novavax stated in a statement that there was no substantial difference in rates of myocarditis between clinical trial participants who received the vaccine (0.007%) and those who received a placebo (0.005%). Novavax Seeks US Authorization In November, Indonesia became the first country to grant emergency use authorization for Novavax’s COVID-19 vaccine. It has also been licensed in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines, and New Zealand, among other countries. In late January, Novavax announced that it had submitted an application for the FDA to authorize its coronavirus vaccine for emergency use. The application was based on data including the results of two large clinical trials that showed an overall efficacy of around 90% and a “reassuring safety profile”, according to the company. The trials were conducted before the omicron variant of the coronavirus took hold in the United States. “The Advisory Committee’s positive recommendation recognizes the strength of our data and the importance of a protein-based COVID-19 vaccine developed with an innovative approach to traditional vaccine technology,” said Stanley Erck, President and CEO of Novavax. , in a statement after Tuesday’s meeting. “We heard at today’s VRBPAC meeting of strong support for our vaccine from clinicians, health organizations and consumers who are eagerly awaiting a protein-based vaccine option,” he said. “We look forward to the FDA’s decision.” In general, uptake of Covid-19 vaccines, especially booster doses, in the United States has been slow, with an FDA official describing it as a “very serious” problem at Tuesday’s meeting. “We have a very serious problem with the acceptance of vaccines in the United States, and anything we can do to make people more comfortable and able to accept these potentially life-saving medical products is something we feel compelled to do.” said Dr. Peter Marks, director of the Center for Biological Evaluation and Research. Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and a member of the VRBPAC, asked at the meeting why another vaccine against covid-19 is necessary in the United States when three have already been authorized or approved: those from Pfizer /BioNTech, Moderna and Janssen of Johnson & Johnson. “Janssen’s vaccine is not currently used as a first-line vaccine in the same way as mRNA vaccines, which leaves the question of vaccines to those who might not want an mRNA vaccine because of their concerns,” Marks replied. , referring to vaccines developed by Pfizer/BioNTech and Moderna. “Having a protein-based alternative may be more comfortable for some in terms of their acceptance of the vaccine,” Marks said. More than two-thirds of the US population are fully vaccinated with at least the initial regimen, but Novavax officials have said they plan to apply for the vaccine to be used as a booster dose and in people who received another type of vaccine in your initial regimen. Protein-based vaccines, like Novavax’s, work by making the body’s immune system recognize small, modified pieces of the virus they target. In this case, it is pieces of the coronavirus spike protein. When the genetic sequence of the virus that causes covid-19 was published, scientists around the world quickly identified it as a coronavirus due to the “spike proteins” on its surface. These spikes form large bumps, giving coronaviruses the appearance of wearing crowns. Novavax scientists identified the spike protein gene and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells, specifically cells from the maize armyworm, and induced them to produce the coronavirus spike protein. These virus-like nanoparticles were harvested to make Novavax’s vaccine. Overall, the vaccine relies on recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies. “The idea of ​​the vaccine is to show the immune system something that looks, tastes and acts like a virus, except it doesn’t make you sick. So we made the spike protein. We put it on a particle, basically like a soap bubble, and it’s the size of the virus,” Dr. Gregory Glenn, president of research and development at Novavax, told CNN last year. “It’s not infectious. We never touch the coronavirus itself,” Glenn added. “So it’s given to people, and they give a very spike-only immune response, and I would say the hallmark of our vaccine is that it gives a very strong immune response with very few side effects, and the dose is very small. and the vaccine can be stored at normal refrigeration temperatures.”

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