Coronavirus (Los Angeles: legally, versus, safe)

[goodheathen]

I noticed fewer people at my gym last time. More concerned about safety, I guess.

[wac_432]

It's plateaued in my town. There was a lot more voluntary masking starting a few weeks ago, and that's probably the driver. This last "surge" barely moved the needle on hospitalizations and deaths. Cases topped out at about 25% of the big pre-vax wave.

I assume we'll keep going through these slowly-diminishing cycles for the next few years as new variants crop up. I'm looking forward to getting the kids vaxxed, and getting a booster, so we can have zero worries.

I wonder if the MRNA vaccines will get modified, without having to go through the approval process all over again, so boosters can generate antibodies that are more effective against variants.

[DabOnEm]

Originally Posted by CA4Now

Yes!

The U.S. Food and Drug Administration is poised to fully approve Pfizer Inc.’s coronavirus vaccine early next week as the Biden administration tries to woo more Americans to get the shot.

The approval probably will come Monday or Tuesday, according to one official familiar with the plans, speaking on the condition of anonymity ahead of the announcement. Pfizer’s vaccine has been in use in the U.S. based on an emergency authorization.

https://www.latimes.com/science/stor...oval-next-week

So we all know by now that the current Pfizer-BioNTech vaccine was NOT fully approved, but it's EUA was extended. In fact, the FDA document literally says both vaccines (the other being the Comirnaty vaccine made by pfizer) are legally distinct. What this means is you can sue if you have complications with one, but can't with the other.

Totally not surprised to see the media report on it like it was approved, and even less surprised to see people not dig deeper to find the truth.

[goodheathen]

Please don't spread misinformation here. It is fully approved for almost everyone already able to get it.
https://www.usatoday.com/story/news/...ne/5594543001/

[joosoon]

Originally Posted by citizensadvocate

Interestingly I recently heard on the news that some school districts i.e Ramona and private schools tried to skirt the mask mandate but were ordered by the state that there are no exceptions to the mask mandate even for private schools. That Ramona Unified School district eventually gave in.

Hadn't heard about it because it's a tiny district, but from what I looked up, they rescinded the opt-out until they can craft a better plan to implement it and legally vet the decision. Not seeing anything that said the state forced anyone's hand. How could they? After June 15th, these things have been left up to individual districts to decide.



The state isn't interested in shutting down schools right now, which would require a lot of legal wrangling to do in the best of circumstances. It's a different game today than it was last year.


What worries me about a potential renewed state order is it will throw districts who put intensive planning into this year, out of whack with possible CDPH guidelines. The downside of putting the decision making back at the local level is there will be a mishmash of protocols though. The fallout from that might be a repeat of defectors from one district to another where there are a lot of schools. Unfortunately, a lot of this stuff hangs on the recall results since none of what's going on is (or has been forever) about science. Pure politics at this point. I'm glad we kept the mask order in SDUSD. It just makes it simpler.

[joosoon]

Originally Posted by DabOnEm

So we all know by now that the current Pfizer-BioNTech vaccine was NOT fully approved, but it's EUA was extended.

Isn't the EUA only applicable to the use in the 12-15 year-old category?
That's what it says straight from the source at FDA. Or is there more to it?

[DabOnEm]

Originally Posted by goodheathen

Please don't spread misinformation here. It is fully approved for almost everyone already able to get it.
https://www.usatoday.com/story/news/...ne/5594543001/

You call this USA Today "fact-check" article proof? Why not use the actual FDA document instead, which of course the USA Today article wouldn't link you to. This is what it says there:

Here on the second page of the vaccine approval it says this:
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses.

Why does it say this?
The products are legally distinct with certain differences that do not impact safety or effectiveness.

Read it for yourself here: https://www.cvdvaccine-us.com/images...l_ToPfizer.pdf

[goodheathen]

You omitted the previous, important paragraph.
"On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older."

You also sneakily cut the last part of the second paragraph.
"On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA."


I don't have patience for this.

[DabOnEm]

Originally Posted by goodheathen

You omitted the previous, important paragraph.
"On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older."

I wanted you to point this out. So this Comirnaty vaccine the FDA is talking about, is it available now? Can you request this specific vaccine?

You also sneakily cut the last part of the second paragraph.
"On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA."


I don't have patience for this.

And then you post proof they are just extending the EUA for the curremt pfizer vaccine that people have access to. Nice.

[goodheathen]

It's the same thing.

Medications often have a scientific name or number throughout the research and development process and are given a brand name upon FDA approval.

https://www.nebraskamed.com/COVID/yo...e-or-different

Moderator cut: rude