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FDA Approves First Covid-19 Vaccine

fda.gov

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Re: FDA Approves First Covid-19 Vaccine

#61

Post by ceejayoz »

vlovich123 wrote: post #43
mattbrewsbytes wrote: post #31

An interesting, short read is the difference between Emergency Use Authorization (EUA) and the full FDA approval[0]. Basically it is manufacturing, funding and red tape being the difference, nothing about safety or clinical trials differs. In software terms, EUA is parallel tracked sprints for clinical trials and manufacturing at same time vs. regular approval is Waterfall where manufacturing occurs after approval. […

Why isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…? Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.

Vaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.

Re: FDA Approves First Covid-19 Vaccine

#62

Post by bart_spoon »

giantg2 wrote: post #19
cbg0 wrote: post #13

Earlier quoted context omitted.

More likely than not, they'll just move the goalposts farther and find a different excuse for not getting it.

Or continue an existing reason: "Information is not yet available about potential long-term health outcomes."

Which still wouldn't be a logical argument, given that the same applies regarding long-term health outcomes regarding getting sick with Covid. But I suspect you are right.

Re: FDA Approves First Covid-19 Vaccine

#63

Post by ortusdux »

acdha wrote: post #6

I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”. I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.

I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination.

I want to know when insurance companies will start adjusting rates.

Re: FDA Approves First Covid-19 Vaccine

#64

Post by whymauri »

doliveira wrote: post #51
ibejoeb wrote: post #39

Earlier quoted context omitted.

The US needs it if they want people who are spooked my mRNA tech to get vaccinated. They also need it if they want a vaccine that is the mostly likely to be safe for use in children.

That's assuming they're not going to find out yet another excuse. Both vector vaccines and inactivated virus vaccines have faced just as much opposition.

Yeah, people seem to be forgetting the anti-vaxx movement that was already brewing way before COVID.

Re: FDA Approves First Covid-19 Vaccine

#65

Post by ceejayoz »

throwawaysea wrote: post #48
acdha wrote: post #6

I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”. I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.

It’s not a pivot for me, particularly since I got the vaccine, but I think there are legitimate reasons to be hesitant and removing one reason doesn’t invalidate other reasons people may bring up. The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term? For instance what if it turns out that something approved today turns out to be carcinogenic twenty years from…

> The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term?

By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/af...

> Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose.

Re: FDA Approves First Covid-19 Vaccine

#66

Post by bluGill »

throwawaysea wrote: post #48
acdha wrote: post #6

I’m wondering what the odds are that people will pivot from “it’s experimental” to “it was rushed due to politics/greed”. I think a huge factor will be how many employers, colleges, etc. are now willing and legally able to require vaccination. It’s one thing to say you trust something you read on Facebook more than your doctor and quite another to walk away from a job because of it.

It’s not a pivot for me, particularly since I got the vaccine, but I think there are legitimate reasons to be hesitant and removing one reason doesn’t invalidate other reasons people may bring up. The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term? For instance what if it turns out that something approved today turns out to be carcinogenic twenty years from…

mRNA is a basic building block of life. Your body makes and breaks it down constantly. If there was any worry about it life itself wouldn't be possible.

Re: FDA Approves First Covid-19 Vaccine

#67

Post by aquaticsunset »

ibejoeb wrote: post #22
ceejayoz wrote: post #12

Earlier quoted context omitted.

Of course, we don't have much info on the long-term health outcomes of getting COVID , either. It's like worrying about the long-term impact of breathing fire extinguisher powder while being engulfed by flames.

The government is not compelling you to get covid.

There are literal quotes from governors, senators, and Congressional representatives talking about herd via infection. Suggesting seniors should do their part and die in order to save the economy.

Depending on where you live and who your political alignment is, the government is absolutely compelling you to get COVID.

Re: FDA Approves First Covid-19 Vaccine

#69

Post by jameshart »

eganist wrote: post #2

My biggest concern now is around seeing those who hedged their willingness to get the vaccine on its approval instead find a new reason not to get it. So with that in mind, I'm much more keen on seeing how employers will decide on vaccination mandates now that at least one vaccine is fully approved. Any news yet on whether any more employers are likely implementing mandates (if they haven't already this morning) base…

I’m surprised we haven’t seen more from health insurers - unless they’re gambling on being able to get out of paying for any long term care costs for COVID complications by claiming ‘preexisting condition’ or ‘government said they’d pay for COVID treatment’ they should surely be interested in incentivizing group plan holders (ie employers) to have vaccination programs. When having a vaccination mandate policy shows up as an actual tangible cut in your insurance bill, that will drive some real behavior changes in employers.

Re: FDA Approves First Covid-19 Vaccine

#70

Post by ceejayoz »

HideousKojima wrote: post #54
ceejayoz wrote: post #27

Earlier quoted context omitted.

The government isn't compelling me to get vaccinated, either.

Sure, so long as you don't need groceries in a major city.

Grocery curbside pickup and delivery are readily available in my non-major city.
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