FDA advisers to weigh risks and benefits of Novavax's COVID-19 vaccine
FDA advisers to weigh risks and benefits of Novavax's COVID-19 vaccine
mm hmm. Americans may soon have another COVID-19 vaccine option one made in *** more traditional way than the shots that are currently available. If us regulators sign off nova vaccines shots would be the nation's first protein vaccine that protects against the coronavirus. Of course we want to vaccinate the unvaccinated primary doses, some of whom are waiting for our vaccine. There may be *** small demand for unvaccinated or incompletely vaccinated individuals. But you know when we look at the rate of vaccination in the United States right now it's really plateau. Most Americans have had their primary 1st and 2nd dose and now they're thinking about when to get the third and possibly the 4th dose. And we've demonstrated that you can boost and get *** very good response both if you boost our own vaccine or if you boost one of the other vaccines, we'd like to have as many tools in the toolbox as we can and what I've seen of the Novavax data so far it's *** really impressive protein vaccine. So this might be able to push our antibody response in slightly different ways. Protein vaccines have been used for decades against other diseases. The fighter and Moderna vaccines use different newer M. RNA technology. One thing we've seen with the M. RNA vaccines is that they induce very high levels of neutralizing antibody but they're not durable, those very high levels of neutralizing antibodies wane and hence the need for frequent boosters that we've seen that is one of the hallmarks of protein vaccine immunity is it's very durable the Novavax vaccine combines the protein element with the second component that AIDS immune response. In *** way we fool the immune system, We supercharged immune response by adding this achievement when an immune cell sees that it becomes quite activated and then it's looking for other things that might be associated with being infectious. The FDA is expected to decide this month whether to authorize the shots manufactured at the serum institute in India. They're already used in europe Canada south Korea and elsewhere, Angie *** Associated Press.
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FDA advisers to weigh risks and benefits of Novavax's COVID-19 vaccine
After more than a year with two types of COVID-19 vaccines in use in the United States, another will be up for consideration by the U.S. Food and Drug Administration this week.The FDA's vaccine advisers are set to meet Tuesday to consider Novavax's coronavirus vaccine for the nation.Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe COVID-19 for a period of 2½ months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.Those efficacy numbers were collected before the emergence of the omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against omicron.In an announcement published in December, the company reported that the vaccine had "broad cross-reactivity against omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months."Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine."Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.An increased risk of myocarditis and pericarditis has b