What was rushed through? The messaging from my government (not US) has been that approval process rules have not been changed.
From the article: > for Emergency Use Authorization https://en.wikipedia.org/wiki/Emergency_use_authorization > authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security Rushed, yes, but via an existing set of rules for this sort of sc…
Wasn’t Remdesivir also given emergency approval and is now to be avoided ?
Its likely, that, like the flu jab, those most at risk will get it first. The vast majority of diligent users here will not be beta testers. Depending on how it works that is. It might be more effective to jab those most likely to transmit the disease first. (E.g. medical workers, children before Christmas meeting the family) or it might be better to jab those most at risk first.
My understanding of at least the Pfizer vaccine was that it primarily lowered the risk of developing COVID from a COV-19 infection. Also if I read it properly that means you could/would wond up in the asymptomatic spreader category. IF all of that is true (and if i misunderstood, please correct me!) It would make the most sense to give it to higher risk individuals first.
Someone please correct me if I'm wrong, but the latest I had heard was that _pre-symptomatic_ spread was the issue rather than asysmptomatic. As in, if you got covid but never developed symptoms, you likely never had enough viral load to transmit the virus. If you later showed symptoms then you likely had a high viral load between contraction and showing symptoms and were likely to transmit the virus. So if this stops the symptoms, it may also stop the viral load from reaching transmitable levels.
Thanks to Operation Warp Speed, the first 100m doses are paid for in the US, and at no cost. https://www.hhs.gov/coronavirus/explaining-operation-warp-sp...
No direct consumer-facing cost. > HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. It's a sensible use of taxpayer funds, for sure, but Pfizer isn't doing it as a charitable work.
I believe the Oxford vaccine does require a booster. It’s the J&J that is single shot.
Wondering how they determine which need a booster and which don't. Is this based on phase one data or more of an educated guess?
Phase 1 &2 data. 1 is mostly safety checks, but it involves several dosing profiles (typically starting low) to get a safety profile. 2 tests dose response and more detailed safety. 3 tests efficacy using the dose profile determined by phase 2.
I guess, from a business perspective, a vaccine manufacturer would seldom get a chance or a time like this. We are seeing history in making. Literally the whole world is holding its breath for a vaccine to arrive.
To be fair, every day is history in the making.
Most days nothing happens that will be in the history books. Richard III https://en.wikipedia.org/wiki/Richard_III_of_England was born on October 2, 1452. Most days in 1452 nothing happened that was important enough to go into any history books.
As someone who has some experience with clinical trials and drug approvals, I'd be quite comfortable taking the vaccine. A clinical trial size of 40,000 (20,000 receiving the vaccine) is way larger than a lot of other drugs that people are comfortable taking. Is there zero risk of serious side effects? Of course not, there never is. But the trial gives enough data to say the risk is worth the benefit. Edit: The FDA h…
It also depends on the known safety profile. With AstraZeneca some people already have to take pain medications after taking the vaccine...I wouldn't be comfortable putting using that vaccine without much wider testing. Fortunately I don't need to though, because soon we'll probably have 2 great vaccines to choose from.
I got a tetanus shot about two months ago. I used pain medication (just normal-ass ibuprofen) because the injection site gets very sore after a few days. There's a lot of valid reasons to be concerned about being in the early run of a brand new vaccination, but injection site having a bit of pain is hardly one of them.
Pfizer selected New Mexico, Rhode Island, Tennessee and Texas for their pilot delivery program "due to the states' immunization infrastructures, urban and rural variations, size and population diversity". First batches of vaccine will probably go to frontline medical workers first, followed by frail old people. a paper in Medrxiv favored "older first" model based on evolutionary game theory and mobility data, for lar…
Can you pull out the threads on that argument a little? Taken at face value, it's not meaningful. Bridges launch with huge, sometimes catastrophic problems.
And that's exactly the point. Once it launches it either crashed down or stays up. As for this vaccine it got 30k tests. It's the equivalent of before launching said bridge the entire heavy machinery of the construction company stood on it and didn't collapsed.
Thats quite wrong. Bridges with serious design flaws can stay standing for quite some time and then collapse. Any civil engineering structure can.
I mean, the tower of Pisa is a great example. Serious design flaw: building a structure on a flawed foundation (technically the soil is the problem). The structure stands for centuries, but the inevitability of its collapse is certain until the Italians righted it and strengthened the base.
Basically because the mechanisms this generation of vaccine consist of are much less complex than any before. Historically, vaccines were huge biological black boxes with all kinds of biomachinery inside that weren't understood at all, that weren't even known . Vaccines were routinely developed, purely by clever trial and error search strategies long before any of their actual mechanisms were understood. In particula…
Thank you! Did not know that this vaccine was simpler than past vaccines.
I wouldn't call it "simpler", exactly. Yes, it's just getting the immune system to react to a single protein (albeit by injecting genetic material rather than the protein itself) rather than sending in a whole modified virus, but it's based on a fancy new vaccine technology that hadn't been successfully developed and deployed yet, I believe. Anyway, this[0] is a great rundown of the kinds of vaccines out there and in development. Both this one (Pfizer/BioNTech) and the other one that released data recently (Moderna) are mRNA vaccines.
Same. I'm not an anti-vaxxer or anything like that. But I think "don't use version 1.0" advice applies here just like it does for software. Especially given the possibility that things have been "hurried" in the name of expediency in terms of getting the vaccine(s) developed, tested, and approved. The good news, in a sort of perverse sense, is that some delay to see what happens with "early adopters" is kinda inevita…
[flagged]
You would be foolish not to get vaccinated given what we know about COVID.
Nobody said anything about not getting vaccinated. The point of discussion here is about not rushing to do it the first day the vaccine is available.