Posted on 04/28/2021 12:09:32 PM PDT by SeekAndFind
Novavax may jump ahead of AstraZeneca as the drugmaker most likely to get its COVID-19 vaccine approved next by the FDA, Politico reported April 27.
Below are seven key details about Novavax and its COVID-19 vaccine:
1. Novavax, founded in 1987 and based in Gaithersburg, Md., has never brought a product to market.
2. The drugmaker's COVID-19 vaccine candidate is a subunit vaccine made of proteins resembling those on the surface of the novel coronavirus, which are meant to generate an immune response to the virus. It does not require ultracold storage, as do the COVID-19 vaccines produced by Pfizer and Moderna.
3. Novavax began the first human study of the vaccine May 25. On Dec. 28, the drugmaker started a phase 3 clinical trial for its COVID-19 vaccine, making it the fifth drugmaker to enter phase 3 trials for a COVID-19 vaccine in the U.S.
4. In July, the U.S. granted $1.6 billion to Novavax to develop and manufacture its COVID-19 vaccine candidate. The drugmaker has promised to deliver 100 million doses of the vaccine to the county.
5. Novavax signed a contract Feb. 18 to sell 1.1 billion doses of its COVID-19 vaccine candidate to Covax, the initiative co-led by the World Health Organization to ensure equitable COVID-19 vaccine distribution across the globe.
6. Novavax CEO Stanley Erck said March 1 the vaccine could be granted emergency use authorization by the FDA as early as May.
7. Novavax said March 11 its COVID-19 vaccine was 96.4 percent effective in preventing COVID-19 during its phase 3 U.K. trial. The trial enrolled 15,000 participants between ages 18 and 84, with 27 percent being older than 65. Mr. Erck said Novavax hopes the FDA will allow it to use data from its U.K. trial during the approval process, as the drugmaker's 30,000-participant phase 3 clinical trial is still ongoing in the U.S.
not approval... emergency use authorization. BIG difference.
None of them have won FDA approval, they have been granted emergency use exemptions.
Weird. What else is a treatment for malaria?
Don’t need it now. We have a vaccine surplus. Anyone who has not taken a jab by now does not want it.
FDA Approval??
Emergency Use maybe
FAKE NEWS
Also in line is Covaxin, from India, that a US company has the rights to here. I don’t think it will make it, and if it does frankly I think we’re at market saturation anyway here in the US. Maybe a new vaccine, if it were marketed correctly, might get some hesitant people to take it. Or maybe the opposite.
Anti Malarial drugs have had success in treating and preventing the Chinese Wuhan Flu worldwide.
Good eye for irony.
That does ring a bell, doesn’t it?
Ivermectin, an anti Parasitic, works on Malaria and the Chinese Wuhan Flu.
“not approval... emergency use authorization. BIG difference.”
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When I was a kid, I was happy when my dad authorized me to be out until midnight. Perhaps I would have been even happier had he approved me staying out until midnight? Perhaps it wouldn’t have mattered…I wasn’t about to start QUIBBLING with him.
nickcarraway wrote: “None of them have won FDA approval, they have been granted emergency use exemptions.”
So we should wait seven or eight years for a FDA approval? How many would die from COVID in seven or eight years?
Do you like wearing a mask?
This one has an exceptionally low negative reaction rate.
Pfizer and Moderna both have all the data required to seek full FDA approval. Both are expected to file within the next few weeks. Both are expected to receive full FDA approval in the next few months.
Once they’re fully FDA approved, all good, right?
I have been waiting for NovaVax. Will give it serious consideration when available. Not a sure thing because the spectre of pathogenic priming / antibody-dependent enhancement is still out there for all covid vaxxs.
“Malaria” — weird indeed. Where have we heard about treatments for that disease? Can’t put my finger on it.
How many of these so-called kungflu “vaccines” have been approved by the FDA? I thought it was zero.
Deaths after covid vaccines has been updated today: 3,848
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