Fauci time and the coronavirus vaccine

The American coronavirus vaccine’s Phase 1 clinical trials are bogged down. They began on March 3 and are not scheduled to end until June 1, 2021.

Why fifteen months for the first American vaccine’s clinical trials? The reason is simple. Dr. Anthony Fauci, the director of NIAID (National Institute of Allergy and Infections Diseases), is conducting them in Fauci Time.  (Fauci is also conducting the clinical trials to see if Remdesivir is effective against COVID-19 in Fauci Time – those trials are not scheduled to end until April 1, 2023.)

Normally, during a health emergency, the U.S. gets out a vaccine within months. Take the H1N1 (Swine Flu) pandemic of 2009. The CDC has published a timeline:

  • April 15. First human infection.
  • May 5. School closings affect 607,778 students.
  • July 22. Clinical trials begin.
  • September 15. Four vaccines approved.

So, in 2009, the FDA started its clinical trials of a vaccine on July 22 and approved four vaccines seven weeks later. Meanwhile, in 2019, Fauci’s NIAID started its clinical trials on March 3 and plans to take 15 months to complete them.

U.S. regulations allow for two rapid approval processes for vaccines during a health emergency. One of them, called Accelerated Approval, is the process used to approve the H1N1 vaccines after less than two months of clinical trials. The other, called Emergency Use Authorization, is the process used to approve the anthrax vaccine so that it could be administered to the soldiers invading Iraq.

In the Accelerated Approval process, a single clinical trial phase determines whether the vaccine is safe and whether it creates the required antibodies. In vaccine terminology, these pathogen-specific antibodies are considered to be a “surrogate endpoint,” permitting the vaccine to be approved for use without field studies. For such vaccines, there is a “Phase 4” process during which the success of the vaccine is continuously monitored while it is being used.

The following are among the successful vaccines approved through the Accelerated Approval process:

On March 3, 2020, Dr. Fauci first came into conflict with President Trump. The issue was how long it would take to get out a vaccine. Here’s the CNN report:

Trump was asked about a timeline for a vaccine during the Cabinet Room meeting with pharmaceutical executives and members of his task force.

“I don't know what the time will be. I've heard very quick numbers, that of months. And I've heard pretty much a year would be an outside number. So I think that's not a bad range. But if you're talking about three to four months in a couple of cases, a year in other cases,” Trump said.

But Dr. Antony Fauci, the head of the National Institute of Allergy and Infectious Diseases, immediately corrected the President: “Let me make sure you get the ... information. A vaccine that you make and start testing in a year is not a vaccine that's deployable.”

As Fauci explained the timeline, Trump folded his arms.

Fauci said: “So he's asking the question -- when is it going to be deployable? And that is going to be, at the earliest, a year to a year and a half, no matter how fast you go.”

At the time, most people thought that medical expert Fauci had to be correct. However, it turns out that Trump, not Fauci, was correct. There are three possibilities:

  1. Fauci doesn’t know the vaccine regulations.
  2. Fauci doesn’t know about the vaccines that cured the 2009 epidemic.
  3. Fauci was purposely being deceptive.

There are two ways to take vaccine approval out of Fauci’s hands. The CDC could invoke the Accelerated Approval Process, just as it did during the Swine Flu pandemic. Alternatively, the secretary of HHS could declare a health emergency, which would give the FDA the power to invoke the Emergency Use Authorization process. In either case, a U.S. vaccine could be gotten out in Trump Time, not Fauci Time.

The American coronavirus vaccine’s Phase 1 clinical trials are bogged down. They began on March 3 and are not scheduled to end until June 1, 2021.

Why fifteen months for the first American vaccine’s clinical trials? The reason is simple. Dr. Anthony Fauci, the director of NIAID (National Institute of Allergy and Infections Diseases), is conducting them in Fauci Time.  (Fauci is also conducting the clinical trials to see if Remdesivir is effective against COVID-19 in Fauci Time – those trials are not scheduled to end until April 1, 2023.)

Normally, during a health emergency, the U.S. gets out a vaccine within months. Take the H1N1 (Swine Flu) pandemic of 2009. The CDC has published a timeline:

  • April 15. First human infection.
  • May 5. School closings affect 607,778 students.
  • July 22. Clinical trials begin.
  • September 15. Four vaccines approved.

So, in 2009, the FDA started its clinical trials of a vaccine on July 22 and approved four vaccines seven weeks later. Meanwhile, in 2019, Fauci’s NIAID started its clinical trials on March 3 and plans to take 15 months to complete them.

U.S. regulations allow for two rapid approval processes for vaccines during a health emergency. One of them, called Accelerated Approval, is the process used to approve the H1N1 vaccines after less than two months of clinical trials. The other, called Emergency Use Authorization, is the process used to approve the anthrax vaccine so that it could be administered to the soldiers invading Iraq.

In the Accelerated Approval process, a single clinical trial phase determines whether the vaccine is safe and whether it creates the required antibodies. In vaccine terminology, these pathogen-specific antibodies are considered to be a “surrogate endpoint,” permitting the vaccine to be approved for use without field studies. For such vaccines, there is a “Phase 4” process during which the success of the vaccine is continuously monitored while it is being used.

The following are among the successful vaccines approved through the Accelerated Approval process:

On March 3, 2020, Dr. Fauci first came into conflict with President Trump. The issue was how long it would take to get out a vaccine. Here’s the CNN report:

Trump was asked about a timeline for a vaccine during the Cabinet Room meeting with pharmaceutical executives and members of his task force.

“I don't know what the time will be. I've heard very quick numbers, that of months. And I've heard pretty much a year would be an outside number. So I think that's not a bad range. But if you're talking about three to four months in a couple of cases, a year in other cases,” Trump said.

But Dr. Antony Fauci, the head of the National Institute of Allergy and Infectious Diseases, immediately corrected the President: “Let me make sure you get the ... information. A vaccine that you make and start testing in a year is not a vaccine that's deployable.”

As Fauci explained the timeline, Trump folded his arms.

Fauci said: “So he's asking the question -- when is it going to be deployable? And that is going to be, at the earliest, a year to a year and a half, no matter how fast you go.”

At the time, most people thought that medical expert Fauci had to be correct. However, it turns out that Trump, not Fauci, was correct. There are three possibilities:

  1. Fauci doesn’t know the vaccine regulations.
  2. Fauci doesn’t know about the vaccines that cured the 2009 epidemic.
  3. Fauci was purposely being deceptive.

There are two ways to take vaccine approval out of Fauci’s hands. The CDC could invoke the Accelerated Approval Process, just as it did during the Swine Flu pandemic. Alternatively, the secretary of HHS could declare a health emergency, which would give the FDA the power to invoke the Emergency Use Authorization process. In either case, a U.S. vaccine could be gotten out in Trump Time, not Fauci Time.