https://www.reuters.com/world/us/novavax-files-us-authorization-covid-19-vaccine-2022-01-31

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Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.

Early data published in late December suggests the vaccine is also effective against the fast spreading Omicron variant, which is now the dominant version of the virus in the United States and most of the world.

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Hopefully this spurs those vaccine holdouts that are skeptical if mRNA vaccines to get vaccinated. This is a protein-based vaccine.

No it's just another option for vaccination. Some folks expressed nervousness about receiving the mRNA vaccines. For those folks, this seems like another good option, with J&J being the other non-mRNA vaccine.

gunan01 said:

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No it's just another option for vaccination. Some folks expressed nervousness about receiving the mRNA vaccines. For those folks, this seems like another good option, with J&J being the other non-mRNA mechanism vaccine.

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I might be interested in Novavax if I had comorbidities. Thankfully, I don't.

gunan01 said:

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No it's just another option for vaccination. Some folks expressed nervousness about receiving the mRNA vaccines. For those folks, this seems like another good option, with J&J being the other non-mRNA mechanism vaccine.

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This is not correct. The J&J vaccine is not a "non-mRNA vaccine".

The J&J vaccine uses a genetically modified adenovirus to get your body to produce the spike protein. ALL proteins are made via mRNA. The modified adenovirus contains the genetic information (DNA) your cells need to produce the spike protein.

In the simplest explanation, when the modified adenovirus enters your cells, the DNA enters the nucleus. Your cells then read the DNA and copy it to mRNA to make the protein.

There is simply no way your body can make a protein without mRNA. The difference between the two vaccines is the delivery mechanism - the mRNA vaccines use lipid nanoparticles to deliver mRNA directly. The J&J uses a genetically modified adenovirus to carry DNA that is then transcripted into mRNA, and the mRNA is then translated into proteins.

Serious question: what's the nature of the current emergency which warrants EUA?

gunan01 said:

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https://www.reuters.com/world/us/novavax-files-us-authorization-covid-19-vaccine-2022-01-31

Quote:

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Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.

Early data published in late December suggests the vaccine is also effective against the fast spreading Omicron variant, which is now the dominant version of the virus in the United States and most of the world.

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Hopefully this spurs those vaccine holdouts that are skeptical if mRNA vaccines to get vaccinated. This is a protein-based vaccine.

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Wishful thinking. That ship has sailed.

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90% effective against a variety of concerning coronavirus variants, including Delta.

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Again, we close the barn after the horse has already left.

This board was largely supportive of removing EUA from specific monoclonal antibody treatments due to the changing landscape of the Covid emergency.
Drug companies are seeking expansions of EUA to vaccinate earlier / younger.
A new vaccine now seeks EUA in this shifting landscape.

It all begs a foundational question: what's the actual nature of the emergency at hand, and then (potentially) the follow up question of whether the proposed treatment is worthy of EUA.

So... how would you define the nature of the Covid emergency as it stands today?

gunan01 said:

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It's a good question. The nature of the "emergency" is very different than March 2020.

On one hand, 2500 people are dying daily from COVID-19, and there are still a lot of hospitalized folks. On the other hand, Omicron is well tolerated among vaccinated folks, and mostly well tolerated among non-vaccinated folks. Many states are open, and in Texas it doesn't really feel like a pandemic is still occurring.

Since the "emergency" is improving and well-studied, effective, safe vaccines already exist, I think one could make the argument to force Novavax to go through the full FDA approval process, and not give it EUA.

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I would have no problem with that as long as they revoked any other vaccine EUA. Kinda hard to reject one vaccine for EUA when there are others operating under EUA still (all of them in the US).

Pfizer and Moderna have approved vaccines now, make them use those vs being able to continue on with EUA. Otherwise they are admitting there is still a need.

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I think one could make the argument to force Novavax to go through the full FDA approval process, and not give it EUA.

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and yet EUA is being used for kids under 5

Brad06ag said:

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gunan01 said:

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It's a good question. The nature of the "emergency" is very different than March 2020.

On one hand, 2500 people are dying daily from COVID-19, and there are still a lot of hospitalized folks. On the other hand, Omicron is well tolerated among vaccinated folks, and mostly well tolerated among non-vaccinated folks. Many states are open, and in Texas it doesn't really feel like a pandemic is still occurring.

Since the "emergency" is improving and well-studied, effective, safe vaccines already exist, I think one could make the argument to force Novavax to go through the full FDA approval process, and not give it EUA.

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I would have no problem with that as long as they revoked any other vaccine EUA. Kinda hard to reject one vaccine for EUA when there are others operating under EUA still (all of them in the US).

Pfizer and Moderna have approved vaccines now, make them use those vs being able to continue on with EUA. Otherwise they are admitting there is still a need.

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The moment they stripped EUA for mAB based on the logic of the Omicron variant being too far departed, they should have stripped EUA for ALL of the Alpha-based products.