FDA Vaccine Panel Endorses Pfizer-BioNTech COVID-19 Vaccine

Full FDA approval is likely, and vaccinations could begin next week.

After a day of public deliberation and debate, the members of the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on the question: Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?

The vote was 17 Yes, 4 No, and 1 Abstention.

Considering that the United Kingdom, Canada, and even Saudi Arabia have already approved the vaccine, it seems likely that the FDA's regulators will accept the independent panel's judgement and issue an Emergency Use Authorization for the vaccine within days, if not hours. The rollout of the vaccine could begin next week.

The approval of the Pfizer/BioNTech COVID-19 vaccine bodes well for Moderna's similar vaccine which the same panel will consider next week.

 

Comments

[speedylee]

I'll graciously be last in line to get it. I'm that selfless.

[Chipper Morning Wood--------------------------------------------------------------------------]

Thanks! More for the rest of us.

[sockpuppet catcher]

Fuck off sarcasmic

[speedylee]

Praise Me!

[Spiritus Mundi]

Always let the pawns go first.

[Á àß äẞç ãþÇđ âÞ¢Đæ ǎB€Ðëf ảhf]

Change your handle to slowlee and I'll believe you.

[Brandybuck]

So STILL no approval? Just a vote to send off to approvers? What the fuck?

[DenverJ]

It's almost like it's not really that much of an emergency... or perhaps they are reluctant to lose their power.

[Sometimes Bad Is Bad]

I’m happy we are at the mercy of bureaucrats. Expect to get lots more under a Harris Biteme admin.

Anyway you first.

[Unicorn Abattoir]

Considering that the United Kingdom, Canada, and even Saudi Arabia have already approved the vaccine

I know I get all of my medical information from a mid-east country still largely stuck in the 18th century.

[sarcasmic]

Yeah, those Canucks. They're mostly friendly, but still live in the dark ages. Bless their hearts.

[Minadin]

Only 6 months out of the year.

[Jewce]

Where's the White Gripe to complain that sarc is whining about Canada?

[Diane Reynolds (Paul.)]

Can we please call this what Gavin Newsom correctly called it? The Trump Vaccine?

[Diane Reynolds (Paul.)]

I mean, if it's President Elect Biden, it's The Trump Vaccine. Fair is fair.

[sarcasmic]

So Pfizer had nothing to do with it?

[CDSchrader]

What a stange thing for you to get salty about.

[sarcasmic]

Says the guy getting salty over questioning it being named after Trump.

[CDSchrader]

Oh damn you're so salty you're lying!

[sarcasmic]

Ew, gross! Keep your tongue to yourself you perv!

[CDSchrader]

And now he's pretending to be an idiot hoping we don't notice how salty he is!

[DilIinger]

careful he's very mad

[sarcasmic]

Stop trying to lick me you perverted fuck!

[CDSchrader]

Sarc thinks acting stupid will distract from how salty he is.

[sarcasmic]

You guys are worse than that fat chick I met on Tinder last week. Shit.

[CDSchrader]

And now you're salty and bitching at us about that too!

[SgtBone]

Anyone surprised that this pathetic loser uses tinder?

[Spiritus Mundi]

I'm sure he catfishes.

[damiskec]

What else can he do he's actually mad and we can all see it.

[sarcasmic]

Oh how cute. Yet another peaked-in-high-school who acts no different than when he was seventeen. I truly pity everyone in your social circle.

[ManaDog]

Wow you managed to get even saltier

[damiskec]

Aren't you the guy who is either

1) An actual drunk who lit his life on fire then sought out sympathy on the internet

or

2) someone who lied about being 1 for sympathy on the internet.

You've claimed both.

Do you even have a social circle, what with you constantly seeking approval from people on the internet?

[sarcasmic]

Is this a lesson in loaded questions?

[damiskec]

Either you lied or you're a drunk.

Pretty easy question if you're actually sober.

Of course you already answered. You admitted you are a drunk, but you don't want people to talk about it so you lied, hoping they would stop.

[Diane Reynolds (Paul.)]

No. They merely followed the orders of the Trump Administration.

Trump was like the Steve Jobs of the COVID vaccine.

From behind his desk he said to his staff, "I wanna see a vaccine before the end of 2020... NOW GET ON IT!"

[sarcasmic]

You saying Pfizer had no incentive to come up with a vaccine other than orders from the president?

[Diane Reynolds (Paul.)]

No. It was the Trump... Vaccine...

Why do you hate Gavin Newsom? The man's a genius.

[sarcasmic]

What president wouldn't have thrown a bunch of money at the problem? Trump definitely gets credit for streamlining the process. Not sure others would have.

[SgtBone]

Damn, sarcasmic. I don't even know what to say here. Kudos for a bit of honesty, I suppose.

[Diane Reynolds (Paul.)]

Sarcasmic, I like you, really I do. But you're missing the sarcasm here.

[damiskec]

Nothing new there

[sarcasmic]

I will give Trump credit for getting the process streamlined so it didn't take the usual ten years. But he didn't make it.

[CDSchrader]

What a strange thing for you to continue to be irrationally salty about.

[ManaDog]

"But he didn’t make it."

The idiot thinks people are calling it the Trump vaccine because he made it...

[DenverJ]

Well, Hoover personally built that dam...

[Echospinner]

And Gerald Ford built that aircraft carrier.

I think we should name that 400 mile section of wall TrumpWall and put one of those big logos on it like the hotels.

And paint it gold.

Hey the Trump boys Don jr. and Eric worked for hours with their chemistry sets in the basement on those vaccines. I think they deserve at least a little credit. I mean mRNA-1273 is so boring.

[Don't look at me!]

It will be called the Trump vaccine when works poorly or has bad side effects.

[Echospinner]

Or when they find out it turns people orange after 6 months.

[DenverJ]

Of course he didn't make it, which is why I get annoyed when people blame him for the deaths- since when is the President responsible for stopping global pandemics?

[Echospinner]

He isn’t he is only responsible for providing honest effective leadership.

[markm23]

If that is your criterion, every President since Eisenhower has failed. (And I'm not sure about Ike - the news media of that era routinely covered up scandals for both parties, and Ike was just the last President to retire before I was old enough to begin noticing oddities for myself.)

[Moderation4ever]

This a good thing and we should acknowledge it. I wonder if we take things like this for granted. I remember reading my grandmother journal and noting in it the day that she and her children got the polio vaccine. It was that important that it got a mention.

[Sometimes Bad Is Bad]

I will still wait on this COVID vaccine until I know more. It feels rushed. Especially for a virus that kills less than 0.3% of those that contract it.

Also note that it took two decades until the polio vaccine was approved.

[Syd Henderson]

And causes severe damage to something like ten times that many.

[De Oppresso Liber]

I wish FDA would just do this all the time. Why not?

[Dashay]

"couple times a month"

How many days this month is it already?

[Sarah Palin's Buttplug 2]

You mean Trump was lying when he said hydroxychloroquine cured Trump-Lung?

[Martin Lawrence]

Still no.

[damiskec]

Yeah that was an embarassing fuckup for old PedoPlug, his stupid ass kept crowing about it not working for weeks evan adter that waa priven wrong because he was too stupid to read that it did work.

[Echospinner]

You are joking right?

https://jamanetwork.com/journals/jama/fullarticle/2772922

Here I’ll read it for you:

Question Does treatment with hydroxychloroquine improve clinical outcomes of adults hospitalized with coronavirus disease 2019 (COVID-19)?

Findings In this randomized clinical trial that included 479 hospitalized adults with respiratory symptoms from COVID-19, the distribution of the day 14 clinical status score (measured using a 7-category ordinal scale) was not significantly different for patients randomized to receive hydroxychloroquine compared with placebo (adjusted odds ratio, 1.02).

Meaning These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.

It is only one of many such trials. Nobody uses that stuff on COVID patients anymore. Maybe some quacks on outpatients.

[markm23]

The problem with this and many other studies is that it did not follow the recommended usage. The claim was that hydrocloroquinone administered with zinc at the beginning of an infection, would lessen the severity of the infection. This study left out the zinc and administered hydrocloroquinone beginning ten days after a COVID-19 infection was suspected. In other words, they found that the treatment was no good if you didn't follow the instructions!

That doesn't mean it is any good ever, but such designed-to-fail studies are a waste of time.

[sockpuppet catcher]

Fuck off sarcasmic

[ElvisIsReal]

Luckily I'm so far back in line that by the time my turn comes up everybody will be protected.

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[Nardz]

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[Don't look at me!]

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[Commenter_XY]

Mr. Bailey....It would be nice if you actually wrote a science article explaining how the vaccines work, and what the results actually were, vis a vis hospitalization.

When the Moderna vaccine is approved, I am running, not walking to get it. There are benefits present with Moderna's vaccine we did not see with others. Example: Nobody from the Moderna vaccine was hospitalized from Covid-19...those who did contract it had a much milder form (none were hospitalized).

[Echospinner]

I am hoping to be able to get that one as well when it becomes available. It is the one I have read most about.

Someone had a nice post up here recently explaining how the mRNA vaccines work. Don’t know if I can find it.

My short version is that an mRNA sequence is made which codes for part of the viral spike protein. It is encased in a lipoprotein capsule which will allow it into the cell membrane.

Once in the muscle cell mRNA binds to the ribosome which manufactures the encoded protein. This triggers an immune response which will result in antibodies.

The mRNA does not stick around. It is quickly degraded by the cell and it cannot replicate. The muscle cell stops making the protein after a few days or so and goes on as before.

[Don't look at me!]

And it will be a real hit with the anti GMO people.

[Echospinner]

And the anti vaxers. I already hear people saying “nobody is going to mess with my RNA”.

I am concerned that not enough people will take the vaccine. I see the paranoia already.

Once it is available where the government could really be helpful is a strong public education program. Ads, getting people on TV. Get Oprah and other popular celebrities on board. Maybe the winger crowd would respond to a clip of Trump rolling up his sleeve or is that too much to ask.

[Roberta]

The capsule has a tropism for muscle cells? And somehow the translation product presents at cell surfaces? Does it get glycosylated?

Why couldn't they just manufacture that protein in vitro and put it in a liposome? Does its antigenicity depend on its having been presented at a cell surface?

[Echospinner]

Good questions. I don’t know enough to answer them. I had read that one of the problems they had early on in this technology is when they tried just injecting the RNA directly it was getting eaten up by immune cells and not getting into the muscle so they came up with this capsule.

[Echospinner]

I have assumed it went to muscle cells because that is where you inject it. So it stays local at the injection site. I don’t think it takes a lot of them to start the immune reaction going and they start making clones.

[Ecoli]

Yep, that is an accurate synopsis of how it works. This new technology vaccine is a marvel of simplicity and ingenuity.

[rbike]

My wife has signed up to do the administrative work in vaccinating employees at the hospital a week from Saturday (Dec 19). I think they have 1,000 to 1,500 vaccinations for the hospital employees (5,000+). Bonus pay for doing this.

[Juice]

Moderna's similar vaccine

* superior

[fda]

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