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It's a "new drug" according to the FDA. So it must go through Phase 1, although it can be expedited.

Plus, phases 2 and 3 are EXPENSIVE to run. If the new sequence doesn't have higher levels of neutralizing antibodies, they probably won't pursue Phases 2/3.
Any chance the FDA will skip phase III or even phase II similar to the yearly changes in influenza vax?
 
I was watching an interview with a Virologist on JAMA. Claimed there's a 20 - 50x increase in antibodies after the mRNA booster. Didn't realize it was that dramatic.

So basically....

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It's possible, but they probably want to see at least one iteration go through the process. A combined Phase 2+3 is very likely.

I'm still hoping that annual boosters are not going to be needed.

What Moderna is doing right now is a phase 2 amendment, for the triple-arm booster tests, in parallel with a NIAID phase 1 study of the new vaccine, and a NIAID phase 1 study of the booster:

"An amendment to the Phase 2 study will enroll 60 participants previously vaccinated with mRNA-1273 to receive a single booster dose of either:"

"In parallel, NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to assess the monovalent and multivalent modified mRNA-1273 vaccines as a primary series in naïve individuals and as a booster vaccine in those previously vaccine with mRNA-1273"
 
Nearly the one-year anniversary of the "near zero cases in April" tweet (we'll see if he ends up being right about that, but might have to wait until 2022)...so it's time for a little vaccine FUD from Elon:

"Some debate." WTF. Take a little bit of uncertainty and concern and AMPLIFY. He's learned from the best I suppose.
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B.1.1.7 has spread across much of Europe. Although this article doesn’t mention it specifically, just over half of all new infections in Italy were due to the B.1.1.7 variant in mid-February and I think it’s safe to assume that figure is much higher now. In Germany it has just reached around half of all new infections (just like in a number of U.S. states).

The U.S. has considerably better vaccination rates but we’re also busy loosening restrictions and opening up indoor bars and dining.

 
Wikipedia has a good summary of the global spread of B.1.1.7.

Also worth noting is that variants that include the E484K protein modification, which resists antibodies to the original virus, now represents 30-40% of new infections in New York City. This is mostly due to a local B.1.526 variant rather than the B.1.351 (South Africa) or P.1 (Brazil) variants.

 
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B.1.1.7 has spread across much of Europe. Although this article doesn’t mention it specifically, just over half of all new infections in Italy were due to the B.1.1.7 variant in mid-February and I think it’s safe to assume that figure is much higher now. In Germany it has just reached around half of all new infections (just like in a number of U.S. states).

The U.S. has considerably better vaccination rates but we’re also busy loosening restrictions and opening up indoor bars and dining.

This sucks. Germany has had an actual lockdown for months now. My daughter lives there. They just ended the curfew but everything is still closed down and people are still not allowed to associate with anyone outside of their household. And she says all the Germans she knows abide by the rules and the police actually enforce them. If they are still having a new wave after 5 months of that this is crazy.

Also my wife just told me that according to the pulmonologist at her hospital, while there are fewer hospitalized COVID patients they are much sicker than hospitalized patients have been for a while and they are not responding as well to the current SOC. He thinks the newer variants are more lethal from what he sees. But then there are very few COVID patients being hospitalized so maybe that's a fluke. We should learn just how bad things can get yet again in a couple weeks in the petri dishes named Florida, Texas and the other full on openers.
 
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This is a new and higher estimate of mortality for the variant taking over in Europe and the U.S. now.


Discussion:
We are so lucky to have the best vaccination program in the world (setting aside some very small vaccination programs in small countries that have blown everyone else away). This seems to be holding off the surge here due to B.1.1.7, at least for the time being.

It's a real photo finish here. Hopefully the real surge of vaccinations starts this week as promised, as more Moderna capacity comes online.

Personally, I'm hoping my waitlist for waste vaccine comes through for me this week. I signed up over a week ago at some CVS stores nearby, and I am on call to head down at a moment's notice. Last I checked there were just three people ahead of me, so as long as CVS actually still continues to receive the perishable vaccines, there's a reasonable chance my name will come up this week. The timing seems completely random. Vials can only be open for 6 hours, so if someone is a no-show they can apparently call middle of the day, etc. CVS has been getting some of the J&J recently though, so it's possible I could end up with that. I'd take it, for sure, though I'd prefer Moderna (what they have) or Pfizer. Can always boost it later, probably. Plus I'm not in a vulnerable group, at all. Just age risk.

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I really hope that for school reopenings they do everything in their power to make it safe. Vaccinations of course will continue to help, and hopefully there will be no issues. But we don't want it bouncing around the schools, either. I was looking at the CDC data last night, and it looks like 1 in 11000 cases in children result in death, so ~1 in 44000 infections. That doesn't seem that great! And that doesn't even take into account the risk of children bringing the virus home to their parents who have typically ~10x the risk. And that risk to parents will be highest amongst those parents who are disadvantaged.

I think it's totally possible to reopen fairly safely (meaning only a few deaths as a result - there will be some), but I just hope people don't dismiss the dangers to children. This is a dangerous disease for children as well (looks to me that it was the leading cause of death, by infectious disease, in 2020). Just need to put in measures to (mostly) stop the virus at the doors. I already don't like the nonsense about 3 feet being ok as compared to 6 feet (based on a paper with no useful data, and even Fauci says it was good data...:rolleyes:). The fact is, it probably doesn't matter what 3-foot spacing does vs. 6-foot spacing. You need to keep the virus out of the schools, and you need to know promptly when it DOES enter a school (through testing), so you can limit the impact and protect parents, etc. (It takes time to become infectious, so early information about an outbreak is key for parents to step up protections!) It should not be too difficult to do in these controlled-access environments. But I'm starting to fear it's not going to happen. Hopefully vaccination will continue rapidly, so it doesn't matter too much.
 
Personally, I'm hoping my waitlist for waste vaccine comes through for me this week. I signed up over a week ago at some CVS stores nearby, and I am on call to head down at a moment's notice.
I received my 2nd Pfizer vaccine shot last week exactly one year after WHO officially declared a pandemic on March 11, 2020.

I had the somewhat typical chills, modest fever, and mild headache starting 14 hours after that morning’s vaccination and continuing overnight. The following day I was mildly fatigued. I’m a volunteer Disaster Service Worker with the San Francisco Fire Department and began working through that program at a temporary vaccination clinic in mid-February. I’m getting perilously close to the currently qualified age group (65 years) but am not quite there yet. I ended up getting a spare leftover shot on my first day helping at the clinic. Last week was my ~3 week follow-up shot. It feels good to be vaccinated. I’m looking forward to helping many others achieve the same over the coming weeks.
 
That doesn't seem that great! And that doesn't even take into account the risk of children bringing the virus home to their parents who have typically ~10x the risk. And that risk to parents will be highest amongst those parents who are disadvantaged.
The problem is - the disadvantaged parents are likely to be going out to work themselves. In that case, it is obviously better for the kids to be at school as well.

In Seattle area schools now all the teachers are getting vaccinated. Hopefully before the fall opening of schools for next year, we'll have vaccines for children as well.
 
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