COVID-19 stats and research news - until Nov. 15, 2021

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What is going on with chicken wings? That is serious.
Recently there is often a shortage of different food items.
Wings always become scarce around NFL playoff time.
 
Being announced in a business news outlet. I don't pay too much attention to those sort of articles.
Ya do pay attention to CNN by yer postin of their review of the recent FDA meeting regardin boosters though, just sayin.
 
Ya do pay attention to CNN by yer postin of their review of the recent FDA meeting regardin boosters though, just sayin.
To clarify, I don't pay attention to announcements by a drug company that is the basis for an article in a business news outlet that isn't really targeted at the general public. Especially before Phase 2. Usually waiting until the Phase 3 protocol has been accepted.

Even when Pfizer grandly announced that a booster would be needed for everyone sooner rather than later, I didn't pay that much attention to that press release.

I did look at the timeline for the Pfizer clinical program in 2020. Mostly curious about when recruitment was likely to start and end. It's a very complicated protocol because they combined Phase 1/2/3. That's one reason I pay more attention to Moderna. Just simpler to understand.


In general, I'm more interested in timelines than speculating about possible outcomes of clinical research. The status of the pandemic in 2020 made recruiting tens of thousands of subjects for a double-blind study much easier than usual for vaccine trials. Combined with parallel development of the manufacturing process based on very good Phase 1 & 2 results, that's the reason that completing the initial efficacy and safety analyses was relatively fast. Pfizer and Moderna each had to find 30,000-40,000 willing participants in just a few months. J&J was recruiting subjects at the same time too. They all also had sites in other countries around the world. It was quite an effort that really did pay off.
 
This isn't a good stat at all

Very sad indeed. Delta changed the situation. Just as Alpha and and holiday gatherings did in Nov 2020. Difference is that vaccination became a proven way to avoid serious illness. All states made vaccines available to adults by late April 2021.

I noted this statement about common risk factors that people haven't been talking about as much in 2021.

"Many low-vaccination communities also have high rates of conditions like obesity and diabetes, said Dr. William Moss of Johns Hopkins. And that combination — along with the more contagious delta variant — has proved lethal."
 
Here’s the recent FDA meeting for discussing approval of Cormirnaty booster.
It’s long and discusses other topics.
The FDA ruled tonight to permit emergency use authorization of a booster dose of Pfizer-BioNTech Covid-19 Vaccine for certain populations.
  • individuals 65 years of age and older;
  • individuals 18 through 64 years of age at high risk of severe COVID-19; and
  • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
 
The other news for today is that Moderna may be showing more staying power than Pfizer. Meaning based on on the approved 2-shot protocol and dosage. The two vaccines are based on the mRNA approach but there are differences in delivery approach and dosage.

September 22, 2021
" . . .
The latest such study, published on Wednesday in The New England Journal of Medicine, evaluated the real-world effectiveness of the vaccines at preventing symptomatic illness in about 5,000 health care workers in 25 states. The study found that the Pfizer-BioNTech vaccine had an effectiveness of 88.8 percent, compared with Moderna’s 96.3 percent.

Research published on Friday by the Centers for Disease Control and Prevention found that the efficacy of the Pfizer-BioNTech vaccine against hospitalization fell from 91 percent to 77 percentafter a four-month period following the second shot. The Moderna vaccine showed no decline over the same period.
. . .

“Our baseline assumption is that the mRNA vaccines are functioning similarly, but then you start to see a separation,” said Natalie Dean, a biostatistician at Emory University in Atlanta. “It’s not a huge difference, but at least it’s consistent.”

But the discrepancy is small and the real-world consequences uncertain, because both vaccines are still highly effective at preventing severe illness and hospitalization, she and others cautioned.

“Yes, likely a real difference, probably reflecting what’s in the two vials,” said John Moore, a virologist at Weill Cornell Medicine in New York. “But truly, how much does this difference matter in the real world?”

“It’s not appropriate for people who took Pfizer to be freaking out that they got an inferior vaccine.”
. . .

Ultimately, both vaccines are still holding steady against severe illness and hospitalization, especially in people under 65, Dr. Moore said.

Scientists had initially hoped that the vaccines would have an efficacy of 50 or 60 percent. “We would have all seen that as great result and been happy with it,” he said. “Fast forward to now, and we’re debating whether 96.3 percent vaccine efficacy for Moderna versus 88.8 percent for Pfizer is a big deal.”"
 
Some people may have seen a picture of the black van with the words "Don't get vaccinated" over the name of a funeral home. I didn't realize that happened in Charlotte, NC. The backstory is pretty interesting. It was a way to get attention and seems to have worked. It wasn't the idea of a funeral home director though.

Since Charlotte is right on the SC border, the stats for that metropolitan area have been worse than the Triangle (Raleigh, Durham, Chapel Hill) pretty much since the pandemic started.

September 21, 2021
 
Pfizer went for an sBLA approval for Cormirnaty for a 3rd booster dose for ages 16 and up.

They only received Emergency Use Authorization for Pfizer-BioNTech vax for a 3rd booster for the groups bulleted above.
 
J&J added a couple wrinkles in their Phase 3 protocol. Included testing of a second dose at two different time intervals. While the 1-shot approach is the primary dosing regimen and has more than enough efficacy for FDA approval, the results with a second dose seems to enhance the protective response quite a bit and increases the effectiveness.

September 21, 2021
 
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