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Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: Sarcany
Date: December 29, 2020 09:08PM
[www.sciencemag.org]

...despite a nearly 30-year history making vaccines, Novavax has never won regulatory approval for one of its candidates, and whether the pandemic will finally change that remains to be seen.


Doesn't seem that hard a hill to climb just now in this political climate.


...Novavax’s COVID-19 candidate is one of two protein subunit vaccines—the other is made by the vaccine-making giant Sanofi Pasteur—on which the U.S. government has bet billions of dollars, and the first to enter a pivotal efficacy trial. It consists of tiny lipid particles studded with copies of the spike protein from the pandemic coronavirus SARS-CoV-2. The vaccine’s lipids do not contain the polymer polyethylene glycol that has raised allergic reaction concerns for other COVID-19 vaccines, but it is supplemented by an immune-boosting, plant-derived compound called a saponin.



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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: PeterB
Date: December 29, 2020 10:51PM
I saw that; they're looking for trial volunteers in my area, and specifically looking for people in categories such as mine -- so I'm tempted to volunteer.

What gives me pause though is that this particular company was nearly forced to declare bankruptcy awhile back, and has been held up numerous times in the process of making this vaccine by manufacturing delays... not inspiring a lot of confidence (in addition to the 30-year history of never having gotten approval for a vaccine).

Also, they're going to have a lot of trouble finding trial volunteers at this point because I think most who would have volunteered for a trial would have done so by now (for example, for Pfizer, Moderna, J&J, or AstraZeneca). Plus, anyone who is in a high-risk category might want to get vaccinated with one of the approved ones if they can.




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: neophyte
Date: December 30, 2020 08:37AM
Where do I find out how to volunteer for the trial?
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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: PeterB
Date: December 30, 2020 12:26PM
Quote
neophyte
Where do I find out how to volunteer for the trial?

[www.novavax.com]
[clinicaltrials.gov]




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: sekker
Date: December 30, 2020 12:39PM
Dr Fauci has some interesting comments on the Novavax approach, worth a listen if you have the time.
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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: neophyte
Date: December 30, 2020 12:54PM
Quote
PeterB
Quote
neophyte
Where do I find out how to volunteer for the trial?

[www.novavax.com]
[clinicaltrials.gov]

Thanks. Nearest trial site is 3.5h drive. Rats.
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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: RgrF
Date: December 30, 2020 01:00PM
Quote
sekker
Dr Fauci has some interesting comments on the Novavax approach, worth a listen if you have the time.

Link?
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Re: Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays...
Posted by: Sarcany
Date: December 30, 2020 01:33PM
A few more vaccine items in the news, not worth their own threads...

China has a new vaccine.
[www.nytimes.com]

Problems: They haven't published the data yet. No peer review. (Sound familiar?)

But they're already shipping And many countries have orders, notably Pakistan which is way low in priority from Western manufacturers. And the COVAX program is buying some to distribute to poor countries.

The UK's AZ vaccine is another one that COVAX is getting, recently approved for emergency use and way cheaper than the mRNA vaccines but only about 60% effective.

COVAX has orders in for nearly 2 billion vaccines. It's not enough. There are obvious supply-chain issues. And many nations have violent anti-vaxxer problems.



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