Current Events > Pfizer To Seek FDA OK For COVID-19 Vaccine 'Within Days'

(+) Yeah! (+)

https://www.npr.org/sections/health-shots/2020/11/18/936060122/pfizer-to-seek-fda-ok-for-covid-19-vaccine-within-days

Pfizer is ready to ask the Food and Drug Administration to authorize emergency use of the company's COVID-19 vaccine, after an updated analysis of the clinical trial data found the vaccine to be 95% effective.

The results from the final efficacy analysis of the vaccine study were released Wednesday. An interim analysis released Nov. 9 had indicated the vaccine was more than 90% effective.

In the Phase 3 study involving more than 43,000 volunteers, half received the experimental vaccine and half got a placebo. Participants received two shots, spaced 21 days apart.

In a news release describing the trial, Pfizer and its partner BioNTech reported there were 170 cases of COVID-19 among the participants: 162 cases in the people who got the placebo compared with eight seen in volunteers who got the vaccine. Ten cases of severe COVID-19 were seen in the trial: nine of them occurred in the placebo group and one was in the vaccinated group.

The companies said the vaccine's efficacy held up across gender, race, ethnicity and various ages. In people older than 65, a group at elevated risk from COVID-19, the efficacy was 94%.

To assess vaccine safety, the FDA told companies that it wanted two-month follow-up data on at least half of the people in Phase 3 trials before considering applications to authorize emergency use of a vaccine during the pandemic. Pfizer said it had met the FDA milestone.

The most common significant side effect seen in the study was fatigue, at a frequency of 3.8% after a second dose of the vaccine. No serious safety concerns were observed, the company said.

"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," Pfizer Chairman and CEO Albert Bourla said in the release.

The companies' release said they plan to file for an emergency use authorization "within days" with the FDA.

Agency officials have said an outside panel of experts would meet publicly to evaluate any COVID-19 vaccine and advise the agency on whether to grant an EUA. The agency's review process is expected to take weeks.

The companies expect to be able to make up to 50 million vaccine doses, enough for 25 million people, by the end of 2020. Next year's production would be up to 1.3 billion doses, or enough for 650 million people.

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Well... I'll wait and see what happens

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My wife apparently signed up for and was accepted into vaccine trials. Goes on Dec 4th.
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JlM posted...

My wife apparently signed up for and was accepted into vaccine trials. Goes on Dec 4th.

They're still doing trials? I wonder how someone can sign to that sort of stuff

Though I would probably be a bad candidate. Too healthy and I don't go out too much

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So what type of vaccine is it? Is it the type that prevents you from catching corona? Or it the type where you can still catch corona but you less likely to have serious case or die of it?

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Is it a suppository?

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Lebronwon posted...

So what type of vaccine is it? Is it the type that prevents you from catching corona? Or it the type where you can still catch corona but you less likely to have serious case or die of it?

The article has it looking like the former, but it could be both

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I wonder what the distribution is going to be like.

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Personally, I do not trust a Trump-appointed Commissioner of the FDA.
~Just saying.
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Maybe someone can answer this for me. They say only like 8 people who took the real vaccine got COVID.

So- are they actually exposing all of these people to COVID after taking the vaccine, and only 8 people got it?

Or are they giving people the vaccine, and then encouraging them to go live their lives, and then they report back to see if they get COVID in their lives?

Because if it's the latter.... That doesn't seem very scientific

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AlCalavicci posted...

Maybe someone can answer this for me. They say only like 8 people who took the real vaccine got COVID.

So- are they actually exposing all of these people to COVID after taking the vaccine, and only 8 people got it?

Or are they giving people the vaccine, and then encouraging them to go live their lives, and then they report back to see if they get COVID in their lives?

Because if it's the latter.... That doesn't seem very scientific

They're most likely intentionally exposing the control group to corona and exposing the placebo group to a guy who is pretending to have corona.

Likely only people extremely unlikely to die from corona were accepted.

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AlCalavicci posted...

Maybe someone can answer this for me. They say only like 8 people who took the real vaccine got COVID.

So- are they actually exposing all of these people to COVID after taking the vaccine, and only 8 people got it?

Or are they giving people the vaccine, and then encouraging them to go live their lives, and then they report back to see if they get COVID in their lives?

Because if it's the latter.... That doesn't seem very scientific

Im admittedly guessing on this, but if you have the antibodies, youre more or less immune until the antibodies wear off (and even then, youre better equipped to fight it if you catch it in the future due to your T-cells).

So my guess is that the procedure is to give someone the vaccination, see if someone gets sick, and then test for antibodies. Everyone should have had the antibodies afterwards, since the body itself makes those. The percents of success is (Im assuming) the number of people who went through the trial with zero illness effects.


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SiO4 posted...

Personally, I do not trust a Trump-appointed Commissioner of the FDA.
~Just saying.

This
I want to make sure there are no long term side effects, and I don't trust a vaccine that has been rushed this quickly.
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devilminion posted...

This
I want to make sure there are no long term side effects, and I don't trust a vaccine that has been rushed this quickly.

Nope. Literally the last people I trust in this matter.
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what are the logistics in getting almost 400 million people vaxxed?

obviously medical and the elderly/vulnerable get it first

Good thing Trump has nothing to do with this or any vaccine effort.

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Poop2 posted...

what are the logistics in getting almost 400 million people vaxxed?

obviously medical and the elderly/vulnerable get it first

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AlCalavicci posted...

Maybe someone can answer this for me. They say only like 8 people who took the real vaccine got COVID.

So- are they actually exposing all of these people to COVID after taking the vaccine, and only 8 people got it?

Or are they giving people the vaccine, and then encouraging them to go live their lives, and then they report back to see if they get COVID in their lives?

Because if it's the latter.... That doesn't seem very scientific

How isn't it scientific? Like you have two groups and a decent enough sample size to see if the vaccine works. With how in 170 cases, 162 of them got a placebo and 8 got the vaccine... It's clear to see that the vaccine works.

Besides it would be hella unethical to try and purposely give people the actual virus even if you give them the vaccine.


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FursonaNonGrata posted...

dassit

Tryin2GetDaPipe posted...

How isn't it scientific? Like you have two groups and a decent enough sample size to see if the vaccine works. With how in 170 cases, 162 of them got a placebo and 8 got the vaccine... It's clear to see that the vaccine works.

Besides it would be hella unethical to try and purposely give people the actual virus even if you give them the vaccine.

because if you send thousands of people to live their lives to see if they catch Covid, thats too many variations of peoples individual exposures to the virus to really be able to tell if the vaccine did anything or not. What if thousands of people just worked from home and barely went out of their house ? Then youre saying the vaccine is super effective when in reality many people may have just not actually been exposed.


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Tryin2GetDaPipe posted...

Besides it would be hella unethical to try and purposely give people the actual virus even if you give them the vaccine.

It has to be done at some point otherwise you have no way of knowing if the antibodies you've created help against coronavirus.

Usually these early trials are done on terminally ill volunteers.

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