FDA willing to fast track coronavirus vaccine before phase three trials end

[Luce]

FDA willing to fast track coronavirus vaccine before phase three trials

The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times.

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
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So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

Trump will risk any number of people for a headline.

 

[Ethel2]

If the vaccine was fast tracked through phase three of testing out of expediency and the desire to “return to normal” then there is genuine concern that a faulty vaccine will somehow be peddled. Peoples lives depend on a vaccine that actually works rather then the one that is the quickest to made.

I am willing to wait years for a vaccine that is medically sound.

This isn't likely to become politicized, at least in terms of its approval. There is an independent board that oversees this stuff. If, as Fauci says, the evidence of efficacy is "overwhelming" then it will likely be approved for emergency use. It may take years to determine if it is safe long term. I am willing to accept the risk, but its not for everyone. I just don't see that this country can wait years to make 100% certain a Covid vaccine is safe long term.

 

[Unitedwestand13]

This isn't likely to become politicized, at least in terms of its approval. There is an independent board that oversees this stuff. If, as Fauci says, the evidence of efficacy is "overwhelming" then it will likely be approved for emergency use. It may take years to determine if it is safe long term. I am willing to accept the risk, but its not for everyone. I just don't see that this country can wait years to make 100% certain a Covid vaccine is safe long term.

Want to give credence to the anti-vaccine conspiracy theories? Have the federal government push out and support a vaccine that does not work, was pushed out without significant testing, and or fails to deliver results. The damage that would be inflicted to the trust and credibility of the CDC, FDA and other government agencies found to be supporting a faulty vaccine would be catastrophic.

And frankly given how the FDA was pressured by trump to approving blood plasma as a treatment to covid just a week after the fda had stated that current testing did not justify the use of blood plasma, i don’t trust the ability of the fda to withstand political pressure.

 

[Ethel2]

Want to give credence to the anti-vaccine conspiracy theories? Have the federal government push out and support a vaccine that does not work, was pushed out without significant testing, and or fails to deliver results. The damage that would be inflicted to the trust and credibility of the CDC, FDA and other government agencies found to be supporting a faulty vaccine would be catastrophic.

And frankly given how the FDA was pressured by trump to approving blood plasma as a treatment to covid just a week after the fda had stated that current testing did not justify the use of blood plasma, i don’t trust the ability of the fda to withstand political pressure.

The FDA does not judge vaccine trials from what I understand. Its some independent board, not related to the FDA or the CDC-can't remember which board Fauci was quoted as saying has jurisdiction. I agree with you about the CDC and the FDA: they are Trump puppets. The CDC said that testing of close contacts of Covid did not need to be tested; they lost all credibility after that. They were pressured "from the top" to say that. Trump will do anything to improve his chances of being re-elected, no matter the cost in human lives.
We know that any vaccine that is approved will be safe in the short term (weeks to months), and if its shown to reduce the chance that someone gets infected, and that evidence is solid, it should be released. The long term side effects will not be known for a long time, but this is an emergency. People can choose to get it or not. I still think that those who work with the public should be strongly encouraged to take it to avoid infecting innocent people.

Edit: here is the process. The board that oversees this is not an arm of the FDA. Its comprised of scientists, physicians, biostatisticians, and consumer advocates. If the vaccine is not safe and effective they give it the thumbs down and the FDA never sees it:

Following FDA's review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.

One more edit: this is what happens to deal with approved vaccines after they are unleashed on the public:

Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. The VAERS system and how it works is discussed further on this website.

 

[Unitedwestand13]

The FDA does not judge vaccine trials from what I understand. Its some independent board, not related to the FDA or the CDC-can't remember which board Fauci was quoted as saying has jurisdiction. I agree with you about the CDC and the FDA: they are Trump puppets. The CDC said that testing of close contacts of Covid did not need to be tested; they lost all credibility after that. They were pressured "from the top" to say that. Trump will do anything to improve his chances of being re-elected, no matter the cost in human lives.
We know that any vaccine that is approved will be safe in the short term (weeks to months), and if its shown to reduce the chance that someone gets infected, and that evidence is solid, it should be released. The long term side effects will not be known for a long time, but this is an emergency. People can choose to get it or not. I still think that those who work with the public should be strongly encouraged to take it to avoid infecting innocent people.

I will not trust any vaccine released before November 1.

 

[joko104]

FDA willing to fast track coronavirus vaccine before phase three trials

The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times.

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
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So the FDA is already to cut corners to please Trump. This will provide even less incentive for the first wave of vaccinatees to line up for the shots.

^ So now you are an anti-vaxxer! :lamo

 

[joko104]

I will not trust any vaccine released before November 1.

^ Another anti-vaxxer!

Predictable that most Democrats instantly will become anti-vaxxers for their blind hatred of Trump.

 

[Ethel2]

I will not trust any vaccine released before November 1.

Its not going to be released before Nov 1. By then or soon thereafter there may (or may not be) enough data to tell if the vaccine is effective and safe in the short term. If the data is "overwhelming" ( and IMO it will be) first responders, medical people etc will be offered the vaccine. It will likely not be available to high risk people until early 2021 IMO. Distribution is going to be a major issue. Its going to take two doses, at least, for each recipient.

 

[justabubba]

Trump will risk any number of people for a headline.

In this case it is a deadline; double entendre intended.

 

[bomberfox]

It's a disaster. I can no longer trust any part of my government.

One man, 4 years and 250 years in the ****ter.

Fascists tend to do that. This is the culmination of all the extreme right’s fantasies

 

[justabubba]

^ Another anti-vaxxer!

Predictable that most Democrats instantly will become anti-vaxxers for their blind hatred of Trump.

distrust


over 20000 reasons to distrust him