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FDA Approves First Covid-19 Vaccine

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Re: FDA Approves First Covid-19 Vaccine

#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.

[0] https://healthtalk.unchealthcare.org/whats-the-difference-be...

Re: FDA Approves First Covid-19 Vaccine

#33
post #22

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.

That doesn't make it any less dangerous

Re: FDA Approves First Covid-19 Vaccine

#34
post #13
post #10

Earlier quoted context omitted.

It's also possible that its approval will result in more people getting the vaccine due to those people now having an out from their initial reaction that it was rushed (but still sticking to their convictions up to now in order to avoid embarrassment).

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

Exactly like governments are moving goalposts with their measures: one lockdown... second one... wait no, a third one is necessary; herd immunity will be reached at 70% vaccination + infected, ah no actually only vaccinated count and it's 90%... did I say 99%? No, it will be 100%!

Meanwhile in Japan: people living freely their lives with no lockdowns, no forced vaccination, no vaccine pass. Another model is possible but the Western governments are addicted to their power trip.

Re: FDA Approves First Covid-19 Vaccine

#35
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 guess the US military can now mandate it as they've said they will. Time to see how many of the people posting on social media that they'd rather take a dishonorable discharge will follow through.

It will likely be a medical separation.

Re: FDA Approves First Covid-19 Vaccine

#36

Does this have any effect on the exemption from liability for this drug or is that still in effect until 2024? I haven't seen any language on this.

Unrelated to approval status. We handle vaccine injury compensation via a special court and system funded by a tax on vaccine doses so manufacturers don't nope out and threaten the production of vaccines entirely. https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...

But not all vaccines are covered under the program. I assume this one will be. Do you know if this one is?

Re: FDA Approves First Covid-19 Vaccine

#37
post #3

After CDC stops updating stats on deaths/hospitalizations from Covid19 among those fully vaccinated against Covid19. As of August 9, net breakthrough deaths stood at 8/million and net breakthrough hospitalizations stood at 35/million, up 900% and 733%, respectively, since April 20. Current numbers: https://www.cdc.gov/vaccines/covid-19/health-departments/bre... Snapshots: https://archive.today/https://www.cdc.gov/vac…

What if it you compare that to a mortality rate of 1.7%? All of a sudden .001 % death rate seems pretty good. What do I know though — this isn’t my area.

Where exactly do you get the 1.7%? Is it computed the same way the breakthrough deaths are computed? What is the denominator in each case?

I see, you are using this table[1] ... This is the case fatality rate (which is inflated depending on how many infections are never recorded).

Using the numbers provided by the CDC, if we put the cases in the denominator and not the vaccinated population, we have:

Hospitalized or fatal vaccine breakthrough cases reported to CDC 8,054 Deaths† 1,587

†341 (21%) of 1,587 fatal cases reported as asymptomatic or not related to COVID-19.

Now, if the CDC had not stopped reporting the number of infections, we'd have the correct comparison. If we take cases as the cases reported by CDC, we have (1,587 - 341)/8,054 = 15.5% of the cases resulting in death from Covid19 of a person who is fully vaccinated against Covid19.

Why did the CDC stop reporting total breakthrough infections (which would have allowed an apples to apples comparison of CFR here)?

[1]: https://coronavirus.jhu.edu/data/mortality

Re: FDA Approves First Covid-19 Vaccine

#38

Does this have any effect on the exemption from liability for this drug or is that still in effect until 2024? I haven't seen any language on this.

Unrelated to approval status. We handle vaccine injury compensation via a special court and system funded by a tax on vaccine doses so manufacturers don't nope out and threaten the production of vaccines entirely. https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...

The National Childhood Vaccine Injury Act is irrelevant here; the liability protection for all COVID countermeasures, including vaccines, is not under the Vaccine Injury Compensation Program established by that act, but is instead under the Countermeasures Injury Compensation Program established by the Public Readiness and Emergency Preparedness Act.

Re: FDA Approves First Covid-19 Vaccine

#39
post #26

Now do Covaxin. Seriously: what's the hold-up? Why is the US still blocking this vaccine?

The US doesn't need it. Other countries are entirely free to approve it for their citizens.

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.

Re: FDA Approves First Covid-19 Vaccine

#40
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…

Concern? Why? The virus is under control in countries where the vaccine rollout has been swift. Why do you sound so keen to force something on people that they don't want, regardless of their reasons? Shouldn't people have the right to choose what they take? If people can lose their jobs over it then clearly they don't have that right - that's a form of coercion/blackmail.

I think the focus on a small minority of people who don't want to take a vaccine is unhealthy.

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