FDA Approves First Covid-19 Vaccine • Hacker News Board

Re: FDA Approves First Covid-19 Vaccine

#41

Post by wingineer » Mon, Aug 23, 2021, 2:08 PM UTC

ceejayoz wrote: post #20

wingineer wrote: post #16

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...

Yes, and as I understand it, the COVID vaccines under EUA are exempt from even this vaccine court system to date because of an HHS declaration in March 2020. So this isn't changing?

https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-0...

Re: FDA Approves First Covid-19 Vaccine

#42

Post by giantg2 » Mon, Aug 23, 2021, 2:09 PM UTC

ibejoeb wrote: post #35

Saint_Genet wrote: post #5

Earlier quoted context omitted.

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.

Only if they have a medical reason that prevents vaccination. Which is unlikely considering the number of vaccines already required.

Re: FDA Approves First Covid-19 Vaccine

#43

Post by vlovich123 » Mon, Aug 23, 2021, 2:09 PM UTC

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.

Re: FDA Approves First Covid-19 Vaccine

#44

Post by Maxburn » Mon, Aug 23, 2021, 2:09 PM UTC

ceejayoz wrote: post #27

ibejoeb wrote: post #22

Earlier quoted context omitted.

The government is not compelling you to get covid.

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

Yes they are, all sorts of "freedoms" hinge on it now.

Re: FDA Approves First Covid-19 Vaccine

#45

Post by bluGill » Mon, Aug 23, 2021, 2:09 PM UTC

yalogin wrote: post #15

The approval is specifically for 12 and over. Any word/guesses on when it would be available for the rest?

It is 16 and over, not 12 and over.

Nobody knows when under 12 will get an EUA: they need more data before they can apply. Rumor is they will have the data soon and so the EUA will happen by the end of September. This is just a rumor: it seems likely, but could be wishful thinking.

Re: FDA Approves First Covid-19 Vaccine

#46

Post by ceejayoz » Mon, Aug 23, 2021, 2:09 PM UTC

ibejoeb wrote: post #39

ceejayoz wrote: post #32

Earlier quoted context omitted.

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.

The US has the J&J vaccine for that.

Re: FDA Approves First Covid-19 Vaccine

#47

Post by ceejayoz » Mon, Aug 23, 2021, 2:11 PM UTC

Maxburn wrote: post #44

ceejayoz wrote: post #27

Earlier quoted context omitted.

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

Yes they are, all sorts of "freedoms" hinge on it now.

I can't work in certain jobs without a security clearance.

The government is not forcing me to get a security clearance.

Re: FDA Approves First Covid-19 Vaccine

#48

Post by throwawaysea » Mon, Aug 23, 2021, 2:12 PM UTC

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 now? This is one reason I feel mandating vaccines or coercing people using other means (like creating great inconveniences) is not okay.

It also does seem like the approval process may be influenced by political pressure to remove barriers to hesitancy or to support vaccine mandates. My understanding is that the approval timeline here is faster than any previous one. Did the FDA really review the over 300,000 pages submitted for this approval and scrutinize it to the extent necessary? Maybe. But from the outside it seems suspiciously quick based on relative terms.

Re: FDA Approves First Covid-19 Vaccine

#49

Post by nl » Mon, Aug 23, 2021, 2:12 PM UTC

hartator wrote: post #29

Interesting that most comments focus on the social aspect of this instead of deciphering the science behind that approval.

The switch from experimental to full approval is mostly about repeatable and certified manufacturing and logistics. There is no new science in this approval.

Re: FDA Approves First Covid-19 Vaccine

#50

Post by giantg2 » Mon, Aug 23, 2021, 2:12 PM UTC

ibejoeb wrote: post #39

ceejayoz wrote: post #32

Earlier quoted context omitted.

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.

There's the Novavax one. It's been in testing about as long as Pfizer and is US based. It hasn't been pushed along with the help of a larger partner like the others. Maybe they will get there. I would have preferred a vaccine using more traditional technology due to the lack of information on the potential for autoimmune conditions in the future.