Article

2021-08-21 Economy

Full FDA approval of the Pfizer COVID vaccine could come as soon as Monday

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Posted by g(r)omgoru 2021-08-21 05:12|| || Front Page|| [8 views ] Top

#1 Hopefully the approval will apply to delta spike protein mRNA.

Posted by g(r)omgoru 2021-08-21 05:17|| 2021-08-21 05:17|| Front Page Top

#2 With the FDA, it could be approval for the font on their packaging insert.

Posted by M. Murcek 2021-08-21 07:43|| 2021-08-21 07:43|| Front Page Top

#3 ^?????

Posted by g(r)omgoru 2021-08-21 07:54|| 2021-08-21 07:54|| Front Page Top

#4 Moderna set to begin human trials of an HIV vaccine as early as this week following the successful rollout of its COVID-19 shot

Posted by Skidmark 2021-08-21 08:18|| 2021-08-21 08:18|| Front Page Top

#5 I'm sure this means they'll now be legally liable for any "adverse" side effects.

(tho I'll admit, I'm still hoping for a tail)

Posted by Mercutio 2021-08-21 08:48|| 2021-08-21 08:48|| Front Page Top

#6 UK finally approves Regeneron's Covid antibody drug: Watchdog says therapy used on Donald Trump slashes risk of hospitalisation by 70% and can prevent infection... but it's been available in the US since November

Posted by Skidmark 2021-08-21 09:04|| 2021-08-21 09:04|| Front Page Top

#7 apparently, Mercutio is also a Dilbert fan

Posted by Frank G 2021-08-21 09:51|| 2021-08-21 09:51|| Front Page Top

#8 Oh, we're all hoping for some tail, Frank.

Posted by Skidmark 2021-08-21 11:26|| 2021-08-21 11:26|| Front Page Top

#9
If approved does that mean they can be sued?
Which also allow discovery leading to accurate numbers of adverse reactions vs. the "reported" numbers.

Posted by NN2N1 2021-08-21 13:29|| 2021-08-21 13:29|| Front Page Top

#10 #6 Traditionally known as passive immunization - I guess they are not using the term for fear of anti-vaxxers.

I remember we had a article here once how marginal minorities achieve results out of any proportion to their numbers. Anybody remembers more detail?

Posted by g(r)omgoru PB 2021-08-21 13:48|| 2021-08-21 13:48|| Front Page Top

#11 Stages of Vaccine Development and Testing
In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.

First Steps: Laboratory and Animal Studies
Exploratory Stage
This stage involves basic laboratory research and often lasts 2-4 years. Federally funded academic and governmental scientists identify natural or synthetic antigens that might help prevent or treat a disease. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens.

Pre-Clinical Stage
Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. Animal subjects may include mice and monkeys. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research as well as a safe method of administering the vaccine.

Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective. They may also do challenge studies with the animals, meaning that they vaccinate the animals and then try to infect them with the target pathogen.

Many candidate vaccines never progress beyond this stage because they fail to produce the desired immune response. The pre-clinical stages often lasts 1-2 years and usually involves researchers in private industry.

IND Application
A sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration. The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol. The FDA has 30 days to approve the application.

Posted by 746 2021-08-21 13:50|| 2021-08-21 13:50|| Front Page Top

#12 Re #&: Actually, I first said that sometime in 1966 when I sprayed a beer over my date whilst trying to talk with both hands.

Re: #8 - I think I said that too, later the same night.....

Posted by Mercutio 2021-08-21 15:27|| 2021-08-21 15:27|| Front Page Top

#13 The first step to mandated vaccinations.

Posted by Anomalous Sources 2021-08-21 21:33|| 2021-08-21 21:33|| Front Page Top

#14
"I've Dreamed of This Day - Finally World Domination"

Posted by Herb Thud5704 2021-08-21 21:43|| 2021-08-21 21:43|| Front Page Top

23:56 Anymouse
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22:27 Chris
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21:42 Anomalous Sources
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