Coronavirus

[bkp_duke]

NEPA health networks reschedule COVID-19 vaccines due to shortages

So remember when everyone was saying just give all the first vaccine doses to as many people as possible and worry about the second dose later. Well in Pennsylvania some of the providers screwed up and gave doses that were supposed to be allotted for the second dose as a first dose. Now the state is scrambling to get people rescheduled.

It's fine. It's not like the immune cells that cause the 2nd dose disappear.

If it were up to me, I would vaccinate the entire country with a first dose ASAP, as there is a good bit of protection from that (at least with Moderna and Pfizer).

The ONLY reason that providers are anal retentive about the dosing interval (28 days for Moderna, 21 days for Pfizer) is that those are the intervals used in the trials, so there is no data for other intervals, although from a "how the immune system works" perspective, it should be fine even if they are spaced months apart.

 

[ZeApelido]

Alright I've gone 23.5 hours since my 2nd shot. Can I take Ibuprofen now?

 

[bkp_duke]

Alright I've gone 23.5 hours since my 2nd shot. Can I take Ibuprofen now?

If you need it, take it. Don't make yourself miserable over this.

 

[ZeApelido]

If you need it, take it. Don't make yourself miserable over this.

Thanks.

My wife is gonna be thrilled when I tell her I get my advice from a doctor on an internet forum.

 

[bkp_duke]

Looks like I've still got my mojo - I called this weeks ago:

New Data Boost Calls for Single COVID-19 Vaccine Dose
"A single dose of the Pfizer/BioNTech vaccine offers 92.6% efficacy in new calculations based on data submitted to the US Food and Drug Administration (FDA), researchers report."

"Together with previous findings that a single Moderna vaccine dose provides 92.1% efficacy against SARS-CoV-2 infection, investigators propose it is time to defer the second dose to extend protection to more people through single-dose mRNA vaccinations."

Original Source:
https://www.nejm.org/doi/full/10.1056/NEJMc2036242

Yes, if you read the full Medscape article, there is still argument about 1 vs. 2 doses. But if you are looking to stamp out a pandemic, this should not even be a discussion - get as much vaccine first dose into the arms of the public as possible. Deal with 2nd shots later.

It would save lives, and the economy would recover faster.

 

[heltok]

Looks like I've still got my mojo - I called this weeks ago:

New Data Boost Calls for Single COVID-19 Vaccine Dose
"A single dose of the Pfizer/BioNTech vaccine offers 92.6% efficacy in new calculations based on data submitted to the US Food and Drug Administration (FDA), researchers report."

"Together with previous findings that a single Moderna vaccine dose provides 92.1% efficacy against SARS-CoV-2 infection, investigators propose it is time to defer the second dose to extend protection to more people through single-dose mRNA vaccinations."

Original Source:
https://www.nejm.org/doi/full/10.1056/NEJMc2036242

Yes, if you read the full Medscape article, there is still argument about 1 vs. 2 doses. But if you are looking to stamp out a pandemic, this should not even be a discussion - get as much vaccine first dose into the arms of the public as possible. Deal with 2nd shots later.

It would save lives, and the economy would recover faster.

Imo we should not do single doses, we should do half doses. Or maybe even less. And we should delay giving the vaccine to people with antibodies.

 

[chronoreverse]

Frankly, even if the first dose only had 60% efficicacy, IF you had the ability to effectively give it out then it'd be better to give as many people first doses only as quickly as possible. Obviously the vaccine makers wouldn't want to make any claims outside of the testing they've done but people freaking out about it was pretty annoying. But it does make sense to be cautious to some degree so fine.

In my home province up here in Canada, the head doctor in charge of the pandemic response advocated for just delaying the second dose to increase the first doses and all the armchair doctors (aka not actually doctors in the field and often not even doctors at all) got up in arms to try to shout her down. This was the woman who dealt with many other pandemic responses successfully in the past and is an actual expert but gets this kind of treatment.

 

[dhanson865]

A company in Finland has developed a coronavirus breathalyzer: DSA Breathpass.

30 tests/hour capacity, result in 2 minutes.

I misread that as a coronavirus Deathalyzer: DSA Breathpass, and was imagining some sort of torture device based off of Russian roulette. Then when I reread it I was imagining it as a teched up ventilator that tested you over and over while keeping you alive.

Man my imagination was ahead of my reading comprehension on this one.

 

[bkp_duke]

Imo we should not do single doses, we should do half doses. Or maybe even less. And we should delay giving the vaccine to people with antibodies.

Half doses for Moderna, not Pfizer. The Moderna vaccine has 3X as much mRNA as the Pfizer one, and was tested at half doses and showed pretty much the same antibody titers as the full dose. As far as I'm aware, there has been no testing of the Pfizer vaccine at half doses.

 

[AudubonB]

Quite a while since I had something possibly productive for this thread.

If it works for the "original" SARS - and that's a big if, as SARS effectively disappeared before there was the opportunity to test it and all incentive to do so disappeared along with the virus - then,

Hey! This works for me! I can live with that! (if I can live with that.....) :

Wine Could Help You Fight Covid | Wine-Searcher News & Features

 

[EVCollies]

Completely depends upon the FDA. "Swapping out" the mRNA for a new strand is relatively simple. That's the beauty of this technology.

What I don't know, is how well incorporating multiple mRNA strands into a single vaccine dose works with this technology. Most certainly there is a minimum threshold of mRNA that you need per variant to induce an adequate immune response, but it's not clear to me what that is (probably 25% or so of the regular dose, giving the ability to incorporate possibly 3 variant strands into one dose - assuming some excess for losses, etc. - but that's a complete guess on my part). Might also be better to go with a booster shot, composed entirely of just the new strand.

This is what clinical trials are designed to tease out.

I so hope the FDA will approve the technology and allow for the insertion of new strands. Quite similar to the flu shot, no large studies needed for yearly variants.

Looks like I've still got my mojo - I called this weeks ago:

New Data Boost Calls for Single COVID-19 Vaccine Dose
"A single dose of the Pfizer/BioNTech vaccine offers 92.6% efficacy in new calculations based on data submitted to the US Food and Drug Administration (FDA), researchers report."

"Together with previous findings that a single Moderna vaccine dose provides 92.1% efficacy against SARS-CoV-2 infection, investigators propose it is time to defer the second dose to extend protection to more people through single-dose mRNA vaccinations."

Original Source:
https://www.nejm.org/doi/full/10.1056/NEJMc2036242

Yes, if you read the full Medscape article, there is still argument about 1 vs. 2 doses. But if you are looking to stamp out a pandemic, this should not even be a discussion - get as much vaccine first dose into the arms of the public as possible. Deal with 2nd shots later.

It would save lives, and the economy would recover faster.

WOW, 93% efficacy, that should allow for a single shot to get us 2X closer to squashing this virus.

 

[AlanSubie4Life]

I called this weeks ago:


"A single dose of the Pfizer/BioNTech vaccine offers 92.6% efficacy in new calculations based on data submitted to the US Food and Drug Administration (FDA), researchers report.""

Not quite how I remember the conversation going, but maybe I misinterpreted that entire conversation? Shrug. I honestly don't know, haha, life is so confusing these days:

This is in comparison to the Pfizer vaccine, that was only 52% effective at preventing COVID-19 after the first dose

The high uncertainty numbers, after eliminating the initial 10/12/14-day period from the observation interval, are about 92% efficacy for both vaccines.

(As I mentioned elsewhere, this was from Michael Mina; it wasn't an original conclusion on my part.)

No data scientist would ever agree that cutting off the first 14 days is a valid assumption. Ever.

Anyway, it looks like the researchers agreed with me that cutting off the first 14 days was a valid assumption for this case.

I saw this story bouncing around yesterday about how Pfizer was so effective after the first dose. It struck me as really odd, because it was widely publicized by Michael Mina that the efficacy (high uncertainty) was 92% (very wide bounds due to low N), in December! There was literally no new news here; all these calculations had been done and widely publicized in December (though they weren't included in the Pfizer submission).

Knowing this, the decision was made in December by the FDA to continue to give both doses on schedule, even with it widely known that the first dose may well have extremely high efficacy (for unknown duration). I can certainly understand that decision, and I can also understand people who are upset by it.

Unfortunately, Pfizer (to my knowledge) never ran the single-dose trial arm in parallel with the double dose arm (they could have just waited a few more weeks (say, 8-12) before doing a second dose, alternatively). They really, really should have tried to figure this out, but I guess they want to sell as much vaccine as possible, or it was just a terrible oversight. Not sure. Almost certainly will cost thousands of lives (not sure how many exactly), but I don't disagree with the FDA decision...because we really don't have the needed data to be certain (the 92% number is highly uncertain). I just think it's terrible we don't have that high certainty data.

 

[bkp_duke]

It is new data for Pfizer, not Moderna. I made the correct call at the time on Pfizer given the available data, and I stand by that, despite you pulling my quotes out of context.

I was also clear at the time that the data supported HIGH efficacy for Moderna at a single, half dose. I still support that data interpretation, and am happy that the new data supports a single dose, full strength dose for both manufacturers as a viable vaccination option.

 

[AlanSubie4Life]

It is new data for Pfizer,

Your link (https://www.nejm.org/doi/full/10.1056/NEJMc2036242) to that brief letter shows no new data for Pfizer. Just new calculations (the headline in the Medscape article linked is wrong, the summary is correct) based on the original data in the Pfizer submission. The confidence intervals are wide, as was calculated in December. All of these calculations are not actually new; they were already done in December by Dr. Mina, they just were not in the submission.

Researchers, quoting directly from your link:
“We used documents submitted to the Food and Drug Administration (https://www.fda.gov/media/144246/download) to derive the vaccine efficacy beginning from 2 weeks after the first dose to before the second dose”

Again, that is what puzzled me yesterday, when this started bouncing around: there is literally zero additional data provided in that brief letter. We already knew all of that, in December!

I’m sorry that I took your comments out of context. That was not my intent - as I said, I literally could not tell what you meant back then, and I genuinely got the impression that you thought the initial Pfizer data showed efficacy of the first dose to be 52% (and it did, if you include the first 14 days!!!). But at that time, I was just making the claim that was made in your recent link (92+% efficacy not including those 14 days - I suggested we should just ignore those days, just as they did in your link).

No new trial data. Unfortunately.

 

[EnergyMax]

It looks like the UK is going with herd immunity in one dose experiment.

More Than 193 Million Shots Given: Covid-19 Tracker

Scroll to the bottom: 24.6% 1 dose, only 0.9% 2 doses.

 

[EVMeister]

It looks like the UK is going with herd immunity in one dose experiment.

More Than 193 Million Shots Given: Covid-19 Tracker

Scroll to the bottom: 24.6% 1 dose, only 0.9% 2 doses.

That's correct and our government has made it clear that's their intention. To prioritise vaccinating as many people as possible rather than double-dosing people. You can read more about the UK strategy here - UK COVID-19 vaccines delivery plan.

 

[bkp_duke]

That's correct and our government has made it clear that's their intention. To prioritise vaccinating as many people as possible rather than double-dosing people. You can read more about the UK strategy here - UK COVID-19 vaccines delivery plan.

The UK strategy is the correct one, if you are looking to stamp out the pandemic and save lives.

 

[AlanSubie4Life]

Maybe the US FDA can use data gathered from the UK to support a change in strategy - won’t be RCT though! It’s so frustrating. I understand their desire to be data driven, but it is infuriating that we don’t have the most obvious dataset, to enable the FDA to say “go ahead, just a single shot for now.” Would have been so easy to get that good data, last year. As it is, we have no more data that is acceptable to the FDA than we had in December.

Without it, as I said, I completely understand their decision, but it is going to cost lives vs. alternative strategies in the short term. Sad!

It’ll be interesting to see how the UK’s strategy does against the problematic variants (e.g. B.1.351). I think if it weren’t for those, the FDA might have found a good excuse to just give one dose. Immune escape, and driving more such variants to arise, is undoubtedly one of the reasons the FDA are reluctant to go that way. Whether it is really a big problem? Who knows.

 

[bkp_duke]

Maybe the US FDA can use data gathered from the UK to support a change in strategy - won’t be RCT though!

You don't do RCTs after a vaccine is out and in use. You do post-administration analysis. Given that the dataset is 10-1000X larger, this is actually when the best vaccine data is collected, and when you can tease out things like smaller, less severe vaccine reactions that would have not been picked up during the RCT.

Great example is the data coming out of Israel. 700k people have received both shots (all Pfizer), and they are collecting data from all of them.


FYI, the US is also collecting post-vaccine data. I've been filling out a web form sent to me via text every day (for 7 days after the shot) or every week (weeks 2, 3, and 4 after the first or second shot) - a requirement for registering to get the shot. So the US is collecting post-vaccine data at a good clip.

 

[AlanSubie4Life]

You don't do RCTs after a vaccine is out and in use

Yes, I know. Ethical concerns and whatnot. The horse has flown in this country.

So the US is collecting post-vaccine data at a good clip.

Sadly, not from single injections (there would be basically zero data for say 8-12 weeks after injection one and before injection two). Maybe they can just use Pfizer data from another country where they actually do the single-dose arm. No idea if this is planned, in progress, or allowed.

Hopefully we will have great two-dose data about efficacy against B.1.351 shortly.