Posted on 11/19/2020 12:09:58 AM PST by be-baw
ollowing the release of more data from its Covid-19 vaccine Phase 3 clinical trial, the drugmaker Pfizer said Wednesday that it expects to submit an application for what's called emergency use authorization to the Food and Drug Administration "within days."
Another drugmaker, Moderna, has also said it aims to submit an application in the coming weeks. Both companies have announced preliminary results from their vaccine trials showing extremely high levels of efficacy.
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But shots won't be available right when the EUA application is submitted to the FDA, nor immediately after it is granted. Rather, following submission, drugmakers and federal health regulators must complete a series of actions before a vaccine is finally released to the public.
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But shots won't be available right when the EUA application is submitted to the FDA, nor immediately after it is granted. Rather, following submission, drugmakers and federal health regulators must complete a series of actions before a vaccine is finally released to the public.
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If that group ultimately votes in favor of a vaccine, the FDA will consider whether to accept the advisory committee's recommendations and issue an EUA.
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Next, an advisory committee to the Centers for Disease Control and Prevention must make recommendations on which groups should be first in line to receive the vaccine. That group, called the Advisory Committee on Immunization Practices, or ACIP, has scheduled a preliminary meeting on potential Covid-19 vaccines this Monday, Nov. 23, though it does not plan on holding any votes then
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Similar to the FDA considering the VRBPAC's decision, the CDC will consider ACIP's recommendations. It's this step that's needed before people can get the vaccine.
(Excerpt) Read more at nbcnews.com ...
OOPS, Sorry for posting that one paragraph twice.
Everything will go well, as it’s all been set up by Trump.
The only think that needed to “happen first” was the election.
The problem with the Pfizer vaccine is there are limited freezers that are cold enough to store it. We’ve already been told there are none in our state.
The problem with the Pfizer vaccine is there are limited freezers that are cold enough to store it. We’ve already been told there are none in our state.
We are storing it in lab freezers. The problem is, this is an rna virus, change is in its nature. This will b like the flu vax, mandatory for people who work in healthcare and ineffective.
Every year we have the same number of sick outs than we did before the flu vax.
I would rather get Covid and be fully immune to multiple antigenic sites
Yeah that turns out to be the issue with the famous Russian vaccine, as well.
It needs to be kept cold. Very cold.
I didn’t realize that, until reading that yesterday.
MY question is what is he saying at about 26:00 and forward?? Perna says "All Americans must be vaccinated within 24 hours". (Upon issuance of the EUA).
NY cuomo the mafia make believe tough guy wants to deny NY the vaccine, hes out to kill more! All of the hard work and setup was done by trump and his people, If biden steals it he will reap the rewards as the savior of civilization!
translation: Red tape will cause the deaths of thousands, and the vaccine will be released as the savior Joe Biden comes in and will claim he did this for you peons.
Sorry, but they could have done an early release request in August and the vaccine been given to the high risk by mid September or early October.
And yes, like flu vaccine, it should be voluntary: But those in nursing homes or we elders who are high risk should be able to ask to get it now.
in other words, politics are killing people.
As for side effects: The anti vax types point out deaths, but often they are missing that a dozen deaths (which by the way are often not from the vaccine per se, but from pre existing diseases) are the risk but the benefit would be thousands who didn’t die after they got it.
So if you don’t want it, fine.
Deep toward the end of the article, they include some timelines that are closer to the truth (to cover their butts, if people later look back on what they published).
Normal timelines are not going to be followed, so it is misleading to describe them up front (and through the bulk of the article).
Not only are they treating it as an emergency use process, but they also have the highest support and direction (Presidential directive) to further expedite that process, performing their actions in parallel,rather than in sequence.
Review panels would be foolish to wait until studies and their reports are finalized, before taking their first look, or raising their first question. They should have had people meeting with the developers throughout their development and testing, ensuring that requirements were being met, and raising/resolving any concerns along the way. Then they are ready to approve an application as rapidly as possible (the whole point in this case).
Bottom line: No way that normal review/approval timelines will be followed in this case.
I think 48 hours is more realistic, than 4 - 8 weeks (as the article spends most of its time trying to imply).
“While Pfizer did release a clinical protocol of its trial, it only issued a press release; data for the interim analysis has not been peer reviewed or published”
Remember, the vaccine makers are shielded from ANY legal liability for any injury.
I learned yesterday that Pfizer is the largest vaccine maker for cattle etc. They have been making coronavirus vaccines for animals for a long time. That eases my mind a little, but, like my friend, I am worried about what ELSE they may put in the vaccine.
Pollen from ragweed is 100% effective in provoking an immune response in me. Jabbing your body with a foreign substance will cause an immune response in just about anyone.
How did they determine the 95% effectiveness?
In the Moderna trial, it was that 90 people in the placebo group tested positive, and only five in the vaccinated group. Out of 15,000 people in each group. This only proved that the virus is not endemic in the population. Considering there are over 100 other pathogens that cause non specific interference with the rPCR test, and the test is 100% unreliable. No decision of effectiveness can be made. The chances of being exposed to the supposed virus in the general population is below 1%.
The test subjects were not intentionally exposed to the virus, therefore no rate of effectiveness can be made. If you intentionally exposed 10,000 people who had the vaccine, and 500 were infected, you could claim 95%. Only if in the placebo group, all 10,000 were infected.
All claims of effectiveness are complete and total BS.
I learned yesterday that Pfizer is the largest vaccine maker for cattle etc. They have been making coronavirus vaccines for animals for a long time. That eases my mind a little, but, like my friend, I am worried about what ELSE they may put in the vaccine.
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There are corona vaccines for cows, and have. Been for years. And must be given bi annually. These vaccines are not mRNA though, like Phizer and Moderna. Everyone taking one of these over the next 3 years are simply test subjects.
Vaccines created in 3 months cannot be proven to be safe, no matter what politicians may say and for profit big pharma push, especially the brand new mRNA type. The risk of taking an untested vaccine with this low risk cold virus just not worth it.
It might be worth it for folks in residential care facilities.
NYS still has a WuFlu problem in nursing homes, although the enemedia doesn’t report on it much.
Peer review and publication are academic procedures - not part of the Government’s approval process.
There is no need for the vaccine makers to write academic articles and have them peer reviewed - it would take a lot of unnecessary time, and could compromise their valuable intellectual property.
On the other hand, it is absolutely critical to their business to gain regulatory approval. That is what they are working to do.
While the approval authorities should be leaning forward, to prepare each step to go as quickly as possible, the vaccine makers must be. That is their business.
The gloves are off for fighting COVID. Except for those with a political interest in prolonging the crisis, everyone else is willing and eager to take any available extraordinary measure to expedite vaccines.
The approval authorities should be validating every step and every method along the way, so that at the end, all they should really need to do is check the math and spelling.
I feel the same way but I have my mother to consider. I don’t want to get her sick and we are always together.
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