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Drug approvals.

FDA NEWS RELEASE

Coronavirus (COVID-19) Update: July 30, 2021

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Today, the FDA revised the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. 

On Wednesday, the FDA authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months.

 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-30-2021

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How Provincetown shows that things can be okay.

https://news.yahoo.com/eight-hundred-cases-seven-hospitalizations-and-no-deaths-the-provincetown-outbreak-shows-vaccines-work-125324207.html

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In fact, such impositions are returning to parts of the country, as the nation appears to be losing steam against the pandemic. The Provincetown cluster, however, shows that that’s not necessarily the case.

While the Delta variant presents a new challenge, one whose scope was not fully understood until earlier this week, the experience of Provincetown also shows a clear path to defeating the variant.

“Yeah, delta variant is bad. Like really bad,” tweeted Dr. Ashish Jha, an epidemiologist and dean of public health at Brown University.

He then added a crucial caveat: “Our vaccines are good. Like really good.”

Provincetown is proof of that, and of how putting masks back on when infection rates spike can help blunt what might otherwise be a spike. By the time the CDC published its paper on Provincetown, the town seemed to be returning to normal.

 

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13 minutes ago, diehardlionfan said:

Ontario reached 81.2% with one dose and 70.3 with both of eligible (12 and above) citizens.

Ottawa 83% one dose and 72% with both.

It will be great when vaccines are approved for the kids. 

Haven’t been following Canada as much lately, but has your government had to do any mandates yet? What about the vaccine passports?

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On 7/29/2021 at 2:10 PM, AFlaccoSeagulls said:

Also, my god was that post in NFL News just a trainwreck of garbage from that one single poster.

Without naming names, I think I know who you're talking about, but yeah, his mental gymnastics ITT were hilarious to read. The fact is, there are no stats to back him up. 99.2% of all Covid deaths are the UNvaccinated, so these selfish/ignorant science-deniers are hurting themselves more than anything. Actually, that's not quite true, movies are getting pushed back again because of declining weekend grosses in recent weeks due to Delta that THEY helped spread even with vaccinations. Also, don't be surprised if travel and other restrictions are put back in place because of them.

So yeah, #CancelAntiVaxxers

Edited by KManX89
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1 minute ago, KManX89 said:

Without naming names, I think I know who you're talking about, but yeah, his mental gymnastics ITT were hilarious to read. The fact is, there are no stats to back him up. 99.8% of all Covid deaths are the UNvaccinated, so these selfish/ignorant science-deniers are hurting themselves more than anything. Actually, that's not quite true, movies are getting pushed back again because of declining weekend grosses in recent weeks due to Delta that THEY helped spread even with vaccinations. Also, don't be surprised if travel and other restrictions are put back in place because of them.

So yeah, #CancelAntiVaxxers

At this point I'm in the camp of hoping enough of these idiots die so that we can actually make some progress as a society.

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The UK has been interesting to follow. It offers both the most optimistic and pessimistic views of what is to come for the US.

https://www.google.com/amp/s/amp.theatlantic.com/amp/article/619647/
 

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In this way, whatever happens in the U.K. represents a best case for the U.S., a country with lower and patchier vaccine uptake despite having plenty of doses. Delta took over in the U.K. first, so its trajectory is slightly ahead of the United States’. If even the highly vaccinated U.K. cannot keep the virus under control in the coming months, that spells real trouble ahead for Americans. But if the U.K. continues on a reassuring trajectory, then the U.S. might have a shot at containing Delta, provided it quickly raises its vaccination rates among the most vulnerable. If not, even in the reassuring scenario the situation here will be much worse.

The fact that the U.K.’s Delta cases started falling earlier than expected is a pleasant surprise—even a reason for optimism. It’s unlikely the U.K. has reached herd immunity with 58 percent of its population fully vaccinated. But cases dropped nonetheless, and experts pointed to several other factors that may have played a role: schools closing for the summer, weather, and a “pingdemic” in which many exposed people were told to isolate by the National Health Service’s contact-tracing app. The most encouraging explanation, in terms of curbing Delta, is that the peak was accelerated by a onetime event: the Euro 2020 soccer tournament.

 

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2 hours ago, Xenos said:

Haven’t been following Canada as much lately, but has your government had to do any mandates yet? What about the vaccine passports?

The ironic part is that there are no vaccine mandates from the federal gov't.   It shows what not tying the message on vaccination to freedom, or party affiliation, does. 

It also shows how bad the media portrayal of vaccination is.   Your earlier post on Provincetown and the article cited should be how news media are reporting.   Because, frankly, it comes down to this:

1.  Vaccination prevents hospitalization, severe illness including ICU, and death, to a near-perfect degree.   NOTHING is perfect, but we're talking 99.8% hospitalization prevention, and even way higher for ICU/death - unless you're immunocompromised (or you got the Sinopharm vaccine - every other vaccine is awesome) .  It's literally being the unlucky lottery loser if you are vaccinated, have a healthy immune system, and get that sick / die.   

2.  Vaccination doesn't mean you'll never get the virus.  But you won't get seriously ill, unless you're immunocompromised, or the unlucky lottery loser.   If you are unvaccinated, the risk goes way, way, way up.  And worse, given how easily Delta spreads - you're likely subjecting everyone in your household to the risk.   And then everyone in their contact group.    THAT is the problem.  And it's why heavy-vaxxed areas like Provincetown have huge #'s, but extremely low severe cases / hospitalizations - but lower-vaxx areas are getting crushed now.

3. Studies on antibody levels, presence of virus, etc. - are bench science studies, meant to raise Q's.  They have incredibly poor clinical predictive ability.  The lab results do NOT correlate to clinical effectiveness.   Pfizer has the highest antibody levels, sure - but the big 4 (and Novovax) are all incredibly effective.   Basically, we're comparing who has the strongest bomb to take out a small bunch of pests in the 4th floor of a building - but whether it's a C4 explosive that wipes out 10 blocks, to a dynamite explosion that only takes down the building - the pests are wiped out with each form.   Yet this has been twisted around to the misperception in Canada of Pfizer or bust, because our science tables (again with mostly lab leaders) - have come out with hedging language that the public doesn't get.

Put more bluntly - go to 100 ICU's, look at the Covid patients, and you will find it's literally nothing but unvaxxed patients.   And the death rates have a staggering comp.     Getting a vaccine turns Covid into an annoyance....not getting the vaccine, it's like you're back in the other waves.     The messaging in Canada has been WAY better than the US except with the antibody-level / efficacy message, which is why you have the opposite problem - ppl want the vaccine, but want Pfizer over all.

 

Edited by Broncofan
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22 minutes ago, Broncofan said:

The ironic part is that there are no vaccine mandates from the federal gov't.   It shows what not tying the message on vaccination to freedom, or party affiliation, does. 

It also shows how bad the media portrayal of vaccination is.   Your earlier post on Provincetown and the article cited should be how news media are reporting.   Because, frankly, it comes down to this:

1.  Vaccination prevents hospitalization, severe illness including ICU, and death, to a near-perfect degree.   NOTHING is perfect, but we're talking 99.8% prevention, and even higher for death - unless you're immunocompromised (or you got the Sinopharm vaccine - every other vaccine is awesome) .  It's literally being the unlucky lottery loser if you are vaccinated, have a healthy immune system, and get that sick / die.   

2.  Vaccination doesn't mean you'll never get the virus.  But you won't get seriously ill, unless you're immunocompromised, or the unlucky lottery loser.   If you are unvaccinated, the risk goes way, way, way up.  And worse, given how easily Delta spreads - you're likely subjecting everyone in your household to the risk.   And then everyone in their contact group.    THAT is the problem.  And it's why heavy-vaxxed areas like Provincetown have huge #'s, but extremely low severe cases / hospitalizations - but lower-vaxx areas are getting crushed now.

3. Studies on antibody levels, presence of virus, etc. - are bench science studies, meant to raise Q's.  They have incredibly poor clinical predictive ability.  The lab results do NOT correlate to clinical effectiveness.   Pfizer has the highest antibody levels, sure - but the big 4 (and Novovax) are all incredibly effective.   Basically, we're comparing who has the strongest bomb to take out a small bunch of pests in the 4th floor of a building - but whether it's a C4 explosive that wipes out 10 blocks, to a dynamite explosion that only takes down the building - the pests are wiped out with each form.   Yet this has been twisted around to the misperception in Canada of Pfizer or bust, because our science tables (again with mostly lab leaders) - have come out with hedging language that the public doesn't get.

Put more bluntly - go to 100 ICU's, look at the Covid patients, and you will find it's literally nothing but unvaxxed patients.   And the death rates have a staggering comp.     Getting a vaccine turns Covid into an annoyance....not getting the vaccine, it's like you're back in the other waves.     The messaging in Canada has been WAY better than the US except with the antibody-level / efficacy message, which is why you have the opposite problem - ppl want the vaccine, but want Pfizer over all.

 

Thanks for the write up. That’s good to know. But no love  for Moderna? 

What about mixing Pfizer with Astra Zeneca? I hear that created an even bigger antibody boost.

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2 hours ago, Xenos said:

This is the article that should have been written originally about Provincetown. It's also what we saw in GBR with Delta and, hopefully, what we will see here- a short spike that goes as quickly as it came.

My wife told me last night that vaccination rates suddenly became super high and we reached 70% (of adults, I'm assuming). That's great; more of that and we are out of this hole.

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The NFL protocol section is pretty interesting if not kind of sad.

https://www.si.com/nfl/2021/07/26/mmqb-what-deshaun-watson-reporting-to-training-camp-means
 

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And if you notice how many times Sills brings up the unvaccinated group, you can tell there’s some frustration there with holdouts. Sills and the league faced questions that a lot of people have had nationwide—Will this have effects on fertility? Why isn’t it FDA approved? How did it come together so quickly? He, and the league, answered all of those. The answer to the first question is almost certainly no. The answer to the second is there’s a process for FDA approval that naturally takes more time.

As for the last one, Sills has told players and coaches, “Hey, we’ve had the truck that carries this load for a while, the truck that runs around and delivers this, it’s just what’s loaded inside that truck is different now because of what we learned about this particular disease.”

 

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16 minutes ago, minutemancl said:

This is the article that should have been written originally about Provincetown. It's also what we saw in GBR with Delta and, hopefully, what we will see here- a short spike that goes as quickly as it came.

My wife told me last night that vaccination rates suddenly became super high and we reached 70% (of adults, I'm assuming). That's great; more of that and we are out of this hole.

We’ve reached 70% of adults getting one shot a month behind the scheduled goal. But still better late than never. Sadly I also think the rates are going back up because Delta finally hit home for a lot of people. Now we just need a sustained increase. This may happen once more places make it mandatory, the vaccine gets full FDA approval, and kids younger than 12 are eligible.

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59 minutes ago, Xenos said:

Thanks for the write up. That’s good to know. But no love  for Moderna? 

What about mixing Pfizer with Astra Zeneca? I hear that created an even bigger antibody boost.

Moderna is clearly just as good as any of the big 4 with the clinically important outcomes - hospitalization, ICU & death.   The only caveat to the big 4 - J&J probably needs a 2nd booster dose.    Otherwise it’s fine if you got any one of 4.   The clinical protection profiles for the relevant outcomes are virtually identical.   

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13 minutes ago, Broncofan said:

Moderna is clearly just as good as any of the big 4 with the clinically important outcomes - hospitalization, ICU & death.   The only caveat to the big 4 - J&J probably needs a 2nd booster dose.    Otherwise it’s fine if you got any one of 4.   The clinical protection profiles for the relevant outcomes are virtually identical.   

No, I mean the reference about Canadian citizens having a weird obsession with only the Pfizer vaccine in your write up. I figured they would also be opened to another mRNA vaccine that was just as effective, as well as anything that has a high antibody input like the mixed vaccine. Even if it’s not exactly scientifically logical since all four are effective as you already mentioned.

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On 7/29/2021 at 8:48 AM, pwny said:

Didn’t want to derail the topic in NFL News any further, but I needed to say this:

This 99.998% is just absolutely hilarious. Reported cases of COVID in the US are just under $35M. A 99.998% survival rate would mean that less than 700 people in the US have died from COVID.

But as noted by these people, not only are the death totals fraudulent, but the positive cases are fraudulent too. So once you account for half of those being fake, we’re talking about 350 deaths total across the entire United States. 350. 

Somehow, the entire medical profession has fraudulently reported 611,500 deaths and none of these “friend of a friend who is a nurse and is sickened by the fraud they see every day” has thought to report a single one to the authorities for medical fraud.

How do people believe this crap?

You are correct, it's not a 99.998% survival rate, but it is an extremely high survival rate for those healthy and under 70. These are CDC's own posted numbers:

Age 70+ 94.6% survival rate (pretty bad)

Age 50+ 99.5% survival rate

Under 50 99.97% survival rate

This lines up perfectly with the deaths as well. 

If you are under 50 with no underlying medical conditions and in-shape (overweight is a medical condition even if you are 20lbs overweight), dying from this virus is ridiculously, beyond slim. Almost all of the people that I have been sent a link to that are under 50 are overweight or have a medical condition. Yes, some healthy people under 50 have died, but like I said, that's super beyond rare. 

With that said, it's still a pretty serious virus, I have always been in favor of masking, social distancing, and all of the lockdowns. Although, I wouldn't support anymore future lockdowns at this point. 

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