FDA gives emergency use authorization to 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.

The U.S. Food and Drug Administration on Wednesday authorized Novavax's COVID-19 vaccine for emergency use in adults. It is the fourth coronavirus vaccine available in the United States, and it uses a different type of vaccine technology than the shots already available.Novavax's vaccine will be available as two-dose primary series for people 18 and older. The FDA's independent Vaccines and Related Biological Products Advisory Committee voted in favor of authorization of the vaccine June 7, saying that the benefits of the vaccine outweigh its risks for adults.It is a protein-based vaccine, and such vaccines use harmless protein fragments of the virus to teach the immune system how to spot the virus and fight it off. The vaccine was created out of a genetic sequence of the first strain of the coronavirus.Late-stage trials found that the efficacy of the vaccine against mild, moderate and severe disease is 90.4%, according to the company. There is not sufficient evidence to evaluate the impact of the vaccine on transmission of the virus.Novavax also announced in early July that its vaccine shows "broad" immune response to currently circulating variants, including omicron subvariants BA.4/5.The shots can't be administered until the U.S. Centers for Disease Control and Prevention's independent vaccine advisers weigh in on whether to recommend the vaccine and the CDC director has signed off on the recommendation. The CDC's Advisory Committee on Immunization Practices is scheduled to meet on July 19.On Monday, the Biden administration announced that it had secured 3.2 million doses of the Novavax vaccine.

The U.S. Food and Drug Administration on Wednesday authorized Novavax's COVID-19 vaccine for emergency use in adults.

It is the fourth coronavirus vaccine available in the United States, and it uses a different type of vaccine technology than the shots already available.

Novavax's vaccine will be available as two-dose primary series for people 18 and older. The FDA's independent Vaccines and Related Biological Products Advisory Committee voted in favor of authorization of the vaccine June 7, saying that the benefits of the vaccine outweigh its risks for adults.

It is a protein-based vaccine, and such vaccines use harmless protein fragments of the virus to teach the immune system how to spot the virus and fight it off. The vaccine was created out of a genetic sequence of the first strain of the coronavirus.

Late-stage trials found that the efficacy of the vaccine against mild, moderate and severe disease is 90.4%, according to the company. There is not sufficient evidence to evaluate the impact of the vaccine on transmission of the virus.

Novavax also announced in early July that its vaccine shows "broad" immune response to currently circulating variants, including omicron subvariants BA.4/5.

The shots can't be administered until the U.S. Centers for Disease Control and Prevention's independent vaccine advisers weigh in on whether to recommend the vaccine and the CDC director has signed off on the recommendation. The CDC's Advisory Committee on Immunization Practices is scheduled to meet on July 19.

On Monday, the Biden administration announced that it had secured 3.2 million doses of the Novavax vaccine.

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