Rad Russian posted:

Interesting. Although wouldn't mixing involve "lying" to your shot provider? At least in the US. I just did a Pfizer booster at Walgreens and if you specify Pfizer for the first two shots you have to do a Pfizer booster. They also want to see vaccination card/evidence of the first two shots. I'm guessing you'd need to go "oh I've never had a vaccine and I want first shot of moderna please" to accomplish the mix which means you won't have it all on the same vaccine card.

Jacqueline A. O'Shaughnessy, Ph.D., Acting Chief Scientist, Food and Drug Administration posted:

II. Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

• Janssen Biotech, Inc. will supply the Janssen COVID‐19 Vaccine, either directly or through authorized distributor(s)5 to emergency response stakeholders6 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA;

• The Janssen COVID‐19 Vaccine covered by this authorization will be administered by vaccination providers7 and used only to prevent COVID-19 in individuals ages 18 and older with a single dose primary vaccination and to provide:

• a single booster dose of Janssen COVID-19 Vaccine at least 2 months after the primary vaccination in individuals 18 years of age and older; and
  
• a single booster dose of the Janssen COVID-19 Vaccine as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine, where the eligible population(s) and dosing interval for the heterologous booster dose are the same as authorized for a booster dose of the vaccine used for primary vaccination.
  

• The Janssen COVID‐19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient.

Rad Russian posted:

Interesting. Although wouldn't mixing involve "lying" to your shot provider? At least in the US. I just did a Pfizer booster at Walgreens and if you specify Pfizer for the first two shots you have to do a Pfizer booster. They also want to see vaccination card/evidence of the first two shots. I'm guessing you'd need to go "oh I've never had a vaccine and I want first shot of moderna please" to accomplish the mix which means you won't have it all on the same vaccine card.

Rosalind posted:

Remember that Israeli study saying that the vaccines are less effective at preventing COVID infection compared to unvaccinated people with a previous infection? Well here's a CDC-funded study saying the exact opposite that just came out in this week's MMWR: https://www.cdc.gov/mmwr/volumes/70/wr/mm7044e1.htm

Though this study included people from January 2021 onward, they did a secondary analysis examining just patients during Delta and had a similar finding. The sample size for that analysis was comparatively small, however.

I will note that this study is still subject to many of the same biases that affect observational studies: namely confounding and selection bias. In particular, I'd be worried about confounding by who chooses to receive the vaccine which may have a very different set of confounders in the US vs. Israel.

The authors do propose two possible explanations: (1) that the Israeli study was looking at positive tests in the general population, not lab-confirmed COVID in hospital settings and (2) that the Israeli study only included those 6+ months after vaccination. This could suggest that previous infection protects better against mild infection, but vaccination protects better against hospitalization.

Stickman posted:

I don’t think there’s any reason to expect prior infection to offer much greater relative protection in older folks, though, unless I’m missing something? It’s not absolute protection, it’s protection relative to vaccination.

E: I guess there could be some survivorship bias for prior infection in the elderly, but I don’t think it would be enough to explain the difference.

quote:

For the period February 1, 2021 to October 1, 2021, vaccine effectiveness against infection (VE-I) declined over time (P < 0.01 for time dependence, Table 1), even after adjusting for age, sex, and comorbidity. VE-I declined for all vaccine types (Fig. 1), with the largest declines for Janssen followed by Pfizer-BioNTech and Moderna. Specifically, in March, VE-I was 86.4% (95% CI: 85.2% to 87.6%) for Janssen; 89.2% (95% CI: 88.8% to 89.6%) for Moderna; and 86.9% (95% CI: 86.5% to 87.3%) for Pfizer-BioNTech. By September, VE-I had declined to 13.1% (95% CI: 9.2% to 16.8%) for Janssen; 58.0% (95% CI: 56.9% to 59.1%) for Moderna; and 43.3% (95% CI: 41.9% to 44.6%) for Pfizer-BioNTech.

quote:

Risk of death after SARS-CoV-2 infection was highest in unvaccinated Veterans regardless of age and comorbidity (Fig. 3). However, breakthrough infections were not benign, as shown by the higher risk of death in fully vaccinated Veterans who became infected compared to vaccinated Veterans who remained infection-free.

Platystemon posted:

We know that people with asymptomatic infections have weaker adaptive immune responses.

Old people get more serious infections, eliciting stronger response.

Coronavirus vaccines, in contrast, are of a fixed strength. Maybe a high dose should be investigated in the elderly in the future, as is done for influenza and some other vaccines.

Platystemon posted:

It’s interesting to see the grey breakthrough lines track above the black (unvaccinated yet tested negative), but only for veterans with advanced age or many comorbidities. The authors do not speculate on reasons for this. Missed SARS-CoV-2 infections in the unvaccinated group? Worse compliance with medications in general?

Platystemon posted:

Rad Russian posted:

Interesting. Although wouldn't mixing involve "lying" to your shot provider? At least in the US. I just did a Pfizer booster at Walgreens and if you specify Pfizer for the first two shots you have to do a Pfizer booster. They also want to see vaccination card/evidence of the first two shots. I'm guessing you'd need to go "oh I've never had a vaccine and I want first shot of moderna please" to accomplish the mix which means you won't have it all on the same vaccine card.

Platystemon posted:

Owl, I know that you like arguments, but no one is claiming that that big ol’ inflection point at the end of July is waning protection.

The authors of the paper don’t claim that, I don’t claim that, no one in this topic has yet claimed that. I even had a sentence or two about not being fooled by that inflection point, and I edited to take it out because I decided that no one was actually that foolish.

The comparison is already on the graph itself. There is no protection provided by “unvaccinated”. All changes in the slope of that black line are due to a change in the prevalence of the virus in the community.

brugroffil posted:

I've got my third Pfizer scheduled for Monday but maybe I'll rebook as moderna

cr0y posted:

My sister pointed out that pharmacies may be only thawing a certain brand of vaccines each day, so Monday is Pfizer shots and Tuesday is moderna, etc. Not totally sure but something to keep in mind.

haveblue posted:

NYS actually listed "got the J&J vaccine" as a risk factor that can get you a Moderna or Pfizer booster

Smeef posted:

I'm imagining a sink with some hotdogs thawing on one side and some packs of vaccines in the other.

MadJackal posted:

I really don't want to get a yearly booster like this for the rest of my life.

Sir John Falstaff posted:

https://twitter.com/ashishkjha/status/1456598629599354886

Seems like good news? Although I'd be interested in a take from someone more knowledgeable about these things than I am.

Henrik Zetterberg posted:

I don't know the details of these studies and how they're conducted, but am I reading this correct that 7 people contracted COVID, Pfizer gave them a sugar pill vs the pill that could have possibly saved their life, and they died instead?

Like, I get you need a placebo group, but man that's brutal to read if I have the correct take on it.

The results of that are great though. How many right-wingers who get COVID are going to refuse to take this Pfizermectin because politics?

Bel Shazar posted:

My 'i'm a moderate republican' Q adjacent mother will never touch a Pfizer vaccine but is looking forward to this pill.

Sir John Falstaff posted:

For some reason, the word "vaccine" is triggering in a way "pill" isn't. As such, I suspect this would probably disproportionately help antivaxxers, but less death is probably still a good thing.

cr0y posted:

My sister pointed out that pharmacies may be only thawing a certain brand of vaccines each day, so Monday is Pfizer shots and Tuesday is moderna, etc. Not totally sure but something to keep in mind.

Henrik Zetterberg posted:

I don't know the details of these studies and how they're conducted, but am I reading this correct that 7 people contracted COVID, Pfizer gave them a sugar pill vs the pill that could have possibly saved their life, and they died instead?

Like, I get you need a placebo group, but man that's brutal to read if I have the correct take on it.

dwarf74 posted:

Yeah there's been a substantial debate about this in medical ethics for decades. Placebo groups are great to prove efficacy, but you may be able to prove it without actually giving people sugar pills just by looking at individuals outside the study. At least the control group got standard care....

Henrik Zetterberg posted:

I don't know the details of these studies and how they're conducted, but am I reading this correct that 7 people contracted COVID, Pfizer gave them a sugar pill vs the pill that could have possibly saved their life, and they died instead?

Like, I get you need a placebo group, but man that's brutal to read if I have the correct take on it.

The results of that are great though. How many right-wingers who get COVID are going to refuse to take this Pfizermectin because politics?

Rosalind posted:

The grim truth is that we have to see if the medication works or not. The gold standard for doing so is an RCT. Patients in the control group are given the standard of care. Patients in the experimental group are given an experimental treatment that could very well harm them more than it helps them. Though generally at this stage of the research process we believe the treatment to be safe, there are many studies that have been ended early because it turned out to be worthless as a treatment or even worse harmful.

This is how the testing of new treatments is done. There are proposals and ideas on how to speed up the process slightly, but those are usually operating within regulatory frameworks. We do not have a better way scientifically to determine if a drug works or not.

CeeJee posted:

And yet it's still not possible to do a test with exposing volunteers (who are from an age/health group least likely to get very ill) to infected people at different ranges and with types of masks in controlled settings to get some good information on actual infections. Every paper is still using models or data from the wildly uncontrolled infections in the wild.

Discendo Vox posted:

I am trained in research bioethics, though it's been a few years. There are definitely limits to the scope of permissible consent, but the risk calculus is opaque here. I'd need to do a lot of research to justify a decision one way or the other. I should note that as someone trained in this, the notion of a "challenge trial" wasn't something I'd heard of before COVID-19. I do not think this is the way we've run trials in the past, even during other epidemics.

edit: I doublechecked my 7th ed copy of Beauchamp and Childress's Principles of Biomedical Ethics, which is kinda the keystone textbook on medical ethics, and the idea of challenge trials doesn't come up. Under the usual conventional interpretation of clinical trial research, participants need to have "a favorable balance of benefits over risks"; this is an element necessary in clinical research going back to the Nuremberg Code. The example the book uses is you don't use people with healthy hearts to test a new heart transplant procedure, which seems apposite; you can't even offer people the chance to participate in that situation.

The contravening justification for "challenge trials," an urgent health crisis makes this complicated, because you're weighing the potential collective benefit of a faster vaccine approval against the similar potential individual risk of either a reaction to the treatment or infection with the virus. Neither potential benefit nor potential risk is easy to measure. Historically, this exact sort of urgent health crisis framing has been exactly the sort of thing we try to avoid letting justify research. You really don't want to be in a situation where people with the power to run trials are able to justify meaningful risk of harm to participants based purely on a public good...especially when it's also to the benefit of the researcher/drug company that's running the trials.

edit 2: Art Caplan seems to be the person who's justifying challenge trials; I'm not sure how to feel about that. Caplan is a very, very sophisticated bioethics thinker, but he's also a notorious publicity hound and mercenary who was involved in a disastrous gene therapy study that got the volunteer killed. I think Caplan could make a sophisticated, reasonable-sounding argument for feeding babies into blenders to feed to other babies, and he'd do it for free if there was a TV crew present.

At a minimum, we should expect that the "challenge trial" framing is going to be pushed as a way to justify deteriorating clinical research protections after the current crisis is addressed. It's going to be very useful for researchers and funders to justify in an ever-growing set of circumstances.

edit 3: lmao the wikipedia page for "human challenge study" was made in May; the entire concept is definitely being pursued to damage ethical oversight standards, even if it has some prior historical precedent (which I can't find). It's Cheney's terrorist time bomb all over again.

Thorn Wishes Talon posted:

Yeah, challenge trials are grossly unethical. In addition, they suffer from other serious issues, such as sampling bias: people who volunteer for them tend to be those who need the extra income, for example, and such people may not necessarily be in good condition in terms of health, nutrition, etc.

Owlofcreamcheese posted:

moderna stock just absolutely nosediving right now.

Rosalind posted:

Because a challenge trial is different from an RCT. No one in a drug RCT is deliberately given a disease; they are given an experimental treatment that the best available evidence (typically from animal and extremely small safety studies) says is safe and effective.

Deliberately exposing people to diseases is incredibly fraught ethically. Like one of the major fundamentals of modern bioethics that emerged after World War 2 is that we don't do that.