General Corona virus updates

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Freeloading Rusty

Here comes Rover, sniffin’ at your ass
Jan 11, 2016
26,916
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Rambo John J

Baker Team
First 100
Jan 17, 2015
74,723
73,989
Well I’m a vaccinated anti vaxxer apparently
A Demographic that grows by the day according to that definition

I know a ton of medical folks here that aren't keen on boosters, and this state is making life very hard for those who don't wanna line up for "their shots"...it will get interesting
 
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sparkuri

Pulse on the finger of The Cimmunity
First 100
Jan 16, 2015
37,306
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New dark ages inbound.
Grateful for the time we had.
80's-ish America might've been the greatest era in human history.
 

sparkuri

Pulse on the finger of The Cimmunity
First 100
Jan 16, 2015
37,306
49,108
 

Shinkicker

For what it's worth
Jan 30, 2016
10,397
13,870
Hauler @Hauler

It's red tape.
The FDA process does not prioritize these medications no matter what's going on socially. It's first come first serve.

Both Pfizer and Moderna have now applied for expedited review.
You have to apply first and then ask for that application to be expedited after.
It's also a laborious process and just takes a long time regardless.
Despite the pandemic we made no changes to this process for pandemic related drugs and vaccines
Expedited review can take 6 months (average 10 in reality). Not sure on Moderna but Pfizer applied for Fast Track which guidelines say can be approved in 60 days. Pfizer applied July 13 and they are projecting an answer in September.

Interesting side note, they have replaced the head honcho in the FDA that will be approving this. They replaced the vaccine researcher with a biologics director.

sparkuri @sparkuri !!!!

Under the FDA’s new plan, the director of FDA’s biologics center, Peter Marks, will largely oversee review of the Pfizer application, taking over for Marion Gruber, a 32-year veteran of the FDA who currently heads the office of vaccine research and review within the larger biologics center, according to a second FDA source. A third source familiar with the plan, who like the others spoke on condition of anonymity, said Marks was heavily involved in the review, but did not comment on whether he was formally replacing Gruber in the agency’s chain of command.
 

Shinkicker

For what it's worth
Jan 30, 2016
10,397
13,870
A Tennessee investigation found evidence that the state's fired vaccine chief, Michelle Fiscus, purchased a dog muzzle that she previously claimed someone had mailed in an attempt to intimidate her.

Why it matters: Fiscus, who denied sending herself the muzzle in a Monday tweet, has characterized her firing as a political move driven by Republican state officials after she shared a memo citing state law about whether adolescents can seek medical care, including a COVID vaccine, without their parents' permission.



  • Fiscus and her husband, Brad, had said in multiple interviews, including with CNN's Anderson Cooper, that the muzzle was sent anonymously to her state office through Amazon shortly before her firing.
  • "Someone wanted to send a message to tell her to stop talking, they thought it would be a threat to her," Brad Fiscus told the Tennessean.
Details: The Tennessee Department of Safety & Homeland Security found through a subpoena that the Amazon package containing the muzzle traced back to a credit card in Fiscus' name, according to an investigation report obtained by Axios.

  • When asked by investigators, Fiscus provided information for an Amazon account in her name. It was a different account than the one used to purchase the muzzle.
  • The investigation concluded that "the results of this investigation that purchases from both Amazon accounts were charged to the same American Express credit card in the name of Dr. Michelle D. Fiscus."
  • Fiscus told investigators she felt the muzzle was a threat and she should "stop talking about vaccinating people." The investigation was launched after health department official Paul Peterson alerted the Department of Safety about the apparent threat to Fiscus.

The backdrop: Fiscus was fired amid criticism from Republican lawmakers who were upset about the health department’s efforts to convince teenagers to get the COVID-19 vaccine.

  • Republican lawmakers criticized Fiscus on multiple fronts, highlighting a memo she sent explaining how providers in Tennessee could vaccinate some teenage patients without a parent's approval.
  • The health department released a memo last month stating Fiscus was fired for poor interpersonal communication skills, ineffective management and attempting to steer state money to a nonprofit she founded.
  • Fiscus denied the allegations in the memo and shared years of sterling performance evaluations. She claims she was fired for attempting to do her job well.
What they're saying: In a statement distributed by her husband, Fiscus said she was not aware of the report until Axios shared it.

  • "We have now learned that a second Amazon account had been established under my name using what appears to be a temporary phone, possibly in Washington state," Fiscus said.
  • "I have asked Homeland Security for the unredacted report so that I can investigate further and am awaiting their response," she added.
  • Fiscus did not discuss the use of the American Express card in her name.
Editor's note: The headline of this story has been updated to clarify the investigation's conclusion. It found evidence that Fiscus purchased the dog muzzle.

 

Splinty

Shake 'em off
Admin
Dec 31, 2014
44,116
89,905
Hauler @Hauler



Expedited review can take 6 months (average 10 in reality). Not sure on Moderna but Pfizer applied for Fast Track which guidelines say can be approved in 60 days. Pfizer applied July 13 and they are projecting an answer in September.

Interesting side note, they have replaced the head honcho in the FDA that will be approving this. They replaced the vaccine researcher with a biologics director.

sparkuri @sparkuri !!!!

Under the FDA’s new plan, the director of FDA’s biologics center, Peter Marks, will largely oversee review of the Pfizer application, taking over for Marion Gruber, a 32-year veteran of the FDA who currently heads the office of vaccine research and review within the larger biologics center, according to a second FDA source. A third source familiar with the plan, who like the others spoke on condition of anonymity, said Marks was heavily involved in the review, but did not comment on whether he was formally replacing Gruber in the agency’s chain of command.
I'm using generic verbage that is not accurate to what the FDA calls uses. Thanks. Moderna requested a few weeks after Pfizer.
I'd expect both to be approved in the next couple months.

That's interesting about the changes. I didn't know that. Could be stacking the deck for the corporate reasons (we've seen that) or could be totally normal given that that is a unique time, given that he is the department head, and that apparrently his wing is responsible for certifying vaccines under their usual scope:


Biologics in this case is from 1902 and does not imply the drug classes we think of with the term now.
No I didn't know which wing of the FDA is responsible for vaccines until I looked it up.
 

Splinty

Shake 'em off
Admin
Dec 31, 2014
44,116
89,905
It's like saying stuff in uniform.
Once you are so and so MD and use that to stamp your message, you've invited your licensing agencies input.

It's a difficult line to identify though.
If a doctor is just coming to a different conclusion with the same data, whatevs.

On the other hand there're are people like this:

It doesn't take much to consent a patient "Currently the consensus from the medical community is that there isn't much benefit to this intervention. However there are small studies that suggest there could be some benefit and in my experience the harm is minimal to try and potentially plenty to gain".
"We don't have any large studies on this medication for the use, but physiologically I think it would work because..."

Boom you've appropriately given context to the data and consented with real expectations.
 

Freeloading Rusty

Here comes Rover, sniffin’ at your ass
Jan 11, 2016
26,916
26,589
OAN Interviews Woman Falsely Claiming COVID-19 Vaccine Makes Her Magnetic

On Thursday, Dan Ball, a host for the conservative One America News, interviewed Amelia Miller, a woman who claims she became a human magnet after getting the Pfizer vaccine.

Miller, whom Ball introduced as a pre-law and political science graduate in Northern California, said she got the Pfizer vaccine in June after coming down with COVID-19 last December.

She said that this past Sunday, she started “to feel this extremely strong metallic taste in my mouth” and remembered previous stories of people who claimed to have suddenly become magnetic after being vaccinated.
“I didn’t believe it,” Miller admitted. “I thought all these videos were hoaxes, people are doing it, like you said, for social media fame.”

However, she claims that she was able to stick different types of metal to her skin and, within minutes, had that “really strange and strong metallic taste in my mouth.”

Miller attempted to demonstrate her magnetism, and while one piece of metal did stick, the other fell off.

Ball watched Miller’s failure to, in gymnastics terms, “stick the landing,” and admitted not knowing how to react.