COVID-19 Vaccine Gets Full Federal Approval

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COVID-19 Vaccine Gets Full Federal Approval
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By Dr. Henning Ansorg, M.D., FACP, Health Officer County of Santa Barbara, Department of Public Health

If you've been waiting for full federal approval for a COVID-19 vaccine, the wait is over!

The Pfizer-BioNTech COVID-19 vaccine received full approval on August 23, 2021, from the U.S. Food and Drug Administration (FDA) for persons 16+ years of age. The vaccine, known as the Pfizer-BioNTech COVID-19 vaccine, will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for administration of a third dose in certain immunocompromised individuals.

According to Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research: "Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

FDA-approved vaccines undergo the agency's standard process for reviewing the quality, safety and effectiveness of medical products.

Santa Barbara County, please get vaccinated today! Visit https://publichealthsbc.org/vaccine/ to find a clinic near you.

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KevinSB Aug 27, 2021 11:12 AM
COVID-19 Vaccine Gets Full Federal Approval

I have 2 problems with the state of this mandate dialogue. Preface: I’m over 50 and feel
Privileged to have had the mRNA vaccines available to quickly and consider it a no brainer to be vaccinated over 40 at minimum.
1. Not acknowledging those who’ve recovered with antibodies (can be confirmed with T-detect test)
2. Mandates for those 20 and younger. Here is an article by Johns Hopkins Professor Marty Makary, MD, MPH a subject matter expert who questions CDC “flimsy evidence” for recommendation 2 dose vaccinations for children. This subject matter expert cites the CDC’s 353 number (purported childhood deaths from Covid which haven’t been examined). He conducted research showing no deaths of young people without comorbidities. It’s an important discussion because if the benefit is slim, we need to consider the policy towards children.

https://www.wsj.com/articles/fda-ivermectin-covid-19-coronavirus-masks-anti-science-11627482393?st=ffoc1cf8rmi19g9&reflink=article_copyURL_share

Basicinfo805 Aug 26, 2021 04:31 PM
COVID-19 Vaccine Gets Full Federal Approval

Hey, some people won’t get this shot no matter what. They’re afraid, anxious, suspicious, whatever. Unfortunately it’s a society and we’re all in it together. I hope the vaccine naysayers realize what their actions have led to (people dying, kids losing out on all aspects of their growing up normally, businesses struggling and failing, people losing their livelihoods). Must probably don’t.

On the other hand, I firmly believe in Darwin’s “survival of the fittest” theory.

Let’s hope someway, somehow - in the long run (evolutionarily) our society is improved by this pandemic. Perhaps those who do not think science matters and the greater good DO matter will “be diminished”? because otherwise, they are hurting us all.

a-1630007719 Aug 26, 2021 12:55 PM
COVID-19 Vaccine Gets Full Federal Approval

Good news. An antibody has been found that appears to protect against all members of the SARS coronavirus family that cause respiratory illness in humans:

https://scitechdaily.com/inescapable-covid-19-antibody-discovery-neutralizes-all-known-sars-cov-2-strains/

edney Aug 25, 2021 11:54 PM
COVID-19 Vaccine Gets Full Federal Approval

That list is quite a loose cannon.
The court is going to fine you $5000, take away your job, and your food stamps, the social security you paid into, and jobless benefits? You can't go into the grocery store or to the pharmacy to pick up a prescription or to get the vaccine?

How would you begin to prove the following in court?
"If you cause infection as a result of not being immunized, you will be financially responsible for all of the damages incurred by infected individuals, medical treatment, and hospital fees."
Which government entity is going to mandate vaccination and enforce and collect fines, fees as your dream team?

Who knew progressives were so into authoritarian, and totalitarian regressive solutions over this minor statistically remaining threat of death by COVID. (State of CA claims 99.99% of people over 65, the age group most likely to die are at least one dose vaccinated).
See here: https://www.mayoclinic.org/coronavirus-covid-19/vaccine-tracker

Definitions:
Totalitarian: relating to a system of government that is centralized and dictatorial and requires complete subservience to the state.

Authoritarian: favoring or enforcing strict obedience to authority, especially that of the government, at the expense of personal freedom.

a-1629952694 Aug 25, 2021 09:38 PM
COVID-19 Vaccine Gets Full Federal Approval

FREEDUMB does not include the right to kill others with your stupid behavior. This is a public health issue, and there are plenty of precedents for requiring vaccination.

a-1629935626 Aug 25, 2021 04:53 PM
COVID-19 Vaccine Gets Full Federal Approval

Observe that the same group of butt snorkelers is denying efficacy of masks and vaccines, fantasizing highly effective "treatments" for COVID, and opposing green energy and efforts to deny climate change. Right wing social media lies are their stock currency.

sacjon Aug 26, 2021 10:01 AM
COVID-19 Vaccine Gets Full Federal Approval

VOICE - it's odd to hear you proclaim a blanket statement about all children under 12, when your sole rebuttal against most of my claims (on any given topic) is that I'm making a blanket statement. Weird, huh?

letmego Aug 26, 2021 09:50 AM
COVID-19 Vaccine Gets Full Federal Approval

"For any extended amount of time, like an entire school day, children under 12 simply can’t wear a mask appropriately which negates the benefits a mask provides. " Um, what? My 8 year can, and does. So do the vast majority of students.

Also, not wearing it appropriately "negates the benefits", or not wearing it all day "negates the benefits" ? Which is it? Or both? Because, wearing a mask appropriately actually reduces the spread of COVID. Sure, wearing a mask appropriately for the full 6 hour school day is better than for 4 hours, but that doesn't mean that only wearing it for 4 hours "negates the purpose".

Also, children are allowed to be unmasked while outdoors, meaning it is much easier to mask appropriately during the remaining hours. You need to give our kids credit.

Voice of Reason Aug 25, 2021 05:59 PM
COVID-19 Vaccine Gets Full Federal Approval

For any extended amount of time, like an entire school day, children under 12 simply can’t wear a mask appropriately which negates the benefits a mask provides. Then you need to look at the drawbacks of masking kids in school and asking, where the net benefit to children is, is a legitimate question.

a-1629938645 Aug 25, 2021 05:44 PM
COVID-19 Vaccine Gets Full Federal Approval

Anyone who says masks aren't helpful is flat out lying:

https://www.factcheck.org/2021/08/scicheck-misinformation-about-face-masks/

Voice of Reason Aug 25, 2021 05:09 PM
COVID-19 Vaccine Gets Full Federal Approval

1), no one here is denying the efficacy of vaccines 2) there are no studies that show masking children have a net benefit 3) I literally posted a link and quote from Dr. Fauci from just yesterday touting the very effective monoclonal antibody treatment 4) no one is opposing green energy, we've debated against moving in that direction to quickly until our current issues are shored up (Newsom just approved 5 emergency diesel generators to minimize rolling blackouts). 5) no one was deny climate change, just denying that it is an imminent crisis and if we don't act drastically and immediately we're all going to die. But of course, it's those darn right wing social media liars! It simply couldn't be the ones responding to valid points with names and ad hominem attacks!

sbdude Aug 25, 2021 12:12 PM
COVID-19 Vaccine Gets Full Federal Approval

Most people who did not get vaccinated because the vaccines were not fully approved will find another excuse not to get vaccinated. Some will get the jab, but most just used the lack of approval as an excuse.

jak Aug 25, 2021 10:36 AM
COVID-19 Vaccine Gets Full Federal Approval

A tremendous point in fact. There are a lot of “alternative facts” out there on vaccines and there risks and benefits but ignoring the pure malarkey from both sides, any rational analysis of the real data tells us that with exceedingly rare exceptions being vaccinated is going to not only improve your odds of a happy life but also the odds for many of your fellow travelers on spaceship earth.

ChemicalSuperFreak Aug 24, 2021 02:11 PM
COVID-19 Vaccine Gets Full Federal Approval

Great news for those whose only objection to the Pfizer vaccine was that it was not fully approved. For those who stubbornly believe that vaccines will solve the problem, the CDC just released a study of vaccine efficiency. The mRNA vaccines are only 66% effective against the delta variant, compared to around 91% effective against the original virus used in their brief, initial studies.

https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w

edney Aug 26, 2021 06:03 PM
COVID-19 Vaccine Gets Full Federal Approval

When you look at "all those unvaccinated people" remember 15% of the country is 12 and under.
So it is impossible to vax to greater than 85% over the total US at this time.
18-24 year olds have the worst vax rate 58% and 25-39 are at 62%
This is where most of the work needs to be done, Fines won't work because they don't have the money.
https://www.mayoclinic.org/coronavirus-covid-19/vaccine-tracker

The car insurance example has problems. If you are making payments on a car, you are required to buy uninsured motorist insurance. The insurance that you buy, if you are smart and I think you are, includes medical expenses regardless to whether the other has insurance or not. CA is a mandated "no fault" insurance state as well. A car crash is much easier to figure out for blame than COVID, but we still have to have "no fault" and uninsured motorist just in case. In other words, we are already required to insure the uninsured, the people who are derelict in their civic duties.

I think we will find that it is far easier and far more lucrative for government to add a fee or tax onto the private health insurance plans, or if you are flouting Obamacare, add to the fine/tax you pay if you do not have an approved healthcare plan. This fine/fee/tax will act as a hedge against the unvaxxed. Think of it as you being compelled to buy a "no fault" uninsured COVID carrier plan to cover all the people who are running around infecting each other.
The IRS and Private Insurance carriers are in the business of collecting mandated taxes and fees already, it will just be a bigger number going to the US Treasury.

I also think we should look at the bright side. In 8 months time we rolled out a vaccine and have almost reach herd immunity levels of 70%. If we can approve it for children under 12, we can reach75% even with only 1/3 of children being vaccinated. This is all something only doable in the imaginations of people 20 years ago. Even 10 years ago we'd have had to ride it out for years, unable to close down our economy or pay out huge subsidies because we were fighting out of a recession

dukemunson Aug 25, 2021 05:53 PM
COVID-19 Vaccine Gets Full Federal Approval

Sac - I have. But Loose is taking it much further than that, with jail being the celebrated penalty for not vaccinating. That’s a wild position, that doesn’t take into consideration well… seemingly anything! Covid is here to stay… and that’s whether we all get vaccinated or not. It’s reality. Let’s not go down a nutty dystopian rabbit hole based on irrational fears. We already did that when we nonsensically shut down schools last year. Should we imprison people that don’t get the flu shot or are late getting their booster shot? When the next variant evades the vaccine do we put everyone in prison who doesn’t immediately get that shot? I’m pointing out loose’s thoughts as opposed to yours but it’s a slippery slope you are headed down… and it’s a bit ridiculous to compare the death rate of smallpox and Covid… they are worlds apart.

Get vaccinated and live your life! Honestly it’s kind of crazy how far my fellow vaccinated Edhatters are willing to punish others for a choice they are making. Bene wanted the same punishments for improperly masking vaccinated people!

sacjon Aug 25, 2021 04:54 PM
COVID-19 Vaccine Gets Full Federal Approval

You're right, I can't blame you for this. If my whole identity was founded on the erroneous and delusional belief that I possessed superior reasoning skills and was consistently backed into a corner or just flat out proven wrong by multiple different people time and time again, I too would ignore direct questions and deflect like a skilled gymnast in a laser tag tent. Sorry ol' buddy. Sometimes I forget how it must feel. Have some supper and try again tomorrow.

sacjon Aug 25, 2021 04:24 PM
COVID-19 Vaccine Gets Full Federal Approval

VOICE - exactly, just as you don't use it to suggest you answered a question that you clearly and demonstrably failed to answer, but rather dodged, as usual. Objection overruled!

Voice of Reason Aug 25, 2021 03:36 PM
COVID-19 Vaccine Gets Full Federal Approval

Sac, are you aware it was GENERAL George Washington who ORDERED (a standing army is not a democracy with the typical freedoms granted to civilians) his TROOPS to be inoculated from Small Pox, a diseases that killed 30% of the people who contracted it (vs. what .3% or less for Covid now that we have treatments and voluntary vaccines), in a WAR that saw more US soldiers die from disease than British troops?

sacjon Aug 25, 2021 03:18 PM
COVID-19 Vaccine Gets Full Federal Approval

VOICE - you're right about the vaccine, it is very effective, which is EXACTLY why it should be mandatory. Do you think people should just be able to go ahead and live their lives like normal while the rest of us get vaxxed and take other precautions? Do we do nothing more to encourage the vaccine? Just roll over for their "freedoms?"

sacjon Aug 25, 2021 03:12 PM
COVID-19 Vaccine Gets Full Federal Approval

DUKE - Have you never heard of compulsory vaccinations? Small pox? Measles? Just curious how you feel about George Washington (you know, founding father and all) ordering vax for small pox? How about vax for schools? We're not saying force kids from schools, just saying you can't enroll if you're not vaxxed, just like we used to for decades.

Voice of Reason Aug 25, 2021 02:59 PM
COVID-19 Vaccine Gets Full Federal Approval

So we now have vaccines that are very effective at preventing hospitalization and death, AND treatments that are also very effective at preventing hospitalization and death (up to 85% per Fauci, vaccinated or not) AND recent data is showing the vaccines aren't so great at preventing transmission, yet jailing and ostracizing people that don't want to take the vaccine is apparently a reasonable course of action? You guys spent the past 5 years up in arms about an authoritarian dictator in the white house, whose actions didn't support the rhetoric, yet here you are demanding people take a vaccine or have their livelihoods destroyed, benefits snatched away and imprisoned!

Voice of Reason Aug 25, 2021 02:50 PM
COVID-19 Vaccine Gets Full Federal Approval

We also have very effective treatments for covid now: “Bottom line is this is a very effective intervention for COVID-19. It is underutilized, and we recommend strongly that we utilize this to its fullest,” Fauci said. [https://nypost.com/2021/08/24/fauci-early-use-of-monoclonal-antibodies-can-reduce-hospitalization-death/] DeSantis has been rolling this out in Florida for a while now but he's a FreeDUMB loving CONservative so nothing he does is right.... Why no one is questioning why Fauci didn't say this earlier, and potentially saved tens of thousand of lives is beyond me. I'll give you a hint, the EUA for the vaccine couldn't have been issued if there was a "very effective" treatment and it is absolutely disgusting he waited until after Pfizer's full approval (no EUA needed) to come out and say this. He literally killed people by withholding support for something many have known to work well for some time now.

Sandy792 Aug 25, 2021 02:36 PM
COVID-19 Vaccine Gets Full Federal Approval

Hi LooseCannon, not to sure where you have been over the last month or so but are you aware that if you are vaxxed you can still spread the virus to others. In fact a preprint paper by the prestigious Oxford University Clinical Research Group, published Aug. 10 in The Lancet, found vaccinated individuals carry 251 times the load of COVID-19 viruses in their nostrils compared to the unvaccinated. Furthermore this is not a sterilizing vaccine meaning it cannot stop the spread so whether you like it or not all you vaccinated people will be contributing to all of the dangerous mutant varieties that will be coming out. If you don’t like living in a free country where people can chose what medical products they can put into their bodies without recourse then maybe you should buy yourself a one way ticket to Venezuela or China.

dukemunson Aug 25, 2021 02:35 PM
COVID-19 Vaccine Gets Full Federal Approval

Bene - So vaccinated people need to be penalized too for being too close to you? What about if they wear the wrong type of mask or sneeze in public...monetary fine or something worse? How far do you want to take that...???

dukemunson Aug 25, 2021 02:32 PM
COVID-19 Vaccine Gets Full Federal Approval

Sac - Covid will be endemic...so wildly punitive punishments such as losing your job (any/all jobs???) and forcing kids from school is pretty harsh. Not as harsh as Looses suggestion of jail (which I'm guessing if we asked Loose they would answer that in jail they would obviously be forcibly vaccinated) but still pretty harsh. Are we forcing booster shots at 6 months then too? Flu shots too? It's a (wildly) slippery slope...one where forced and jail are a single degree from your position.

And again, COVID will be endemic. We know this. It's an accepted fact. I'm vaccinated and encourage everyone I encounter to get vaccinated...but we really should be a little careful with how far we take this "forceful" vaccination push.

sacjon Aug 25, 2021 01:17 PM
COVID-19 Vaccine Gets Full Federal Approval

DUKE - I don't see LOOSE saying we should force the shot into their arms, just some very strict (too strict in my opinion) consequences for refusing the vax. People who are holding us back and causing others to die needlessly SHOULD be punished in some way - lose your job, no school for the kids, pay a fine, etc. They are making a choice that puts our society at risk. But no, I do not agree with FORCED shots. Harshly encouraged vaccination yes, but not forcing a needle in the arm.

Bene Aug 25, 2021 12:34 PM
COVID-19 Vaccine Gets Full Federal Approval

I think all these penalties should also apply to the fully vaccinated who refuse to wear masks and think just because they are vaccinated they can slobber all over other people with impunity. I am vaccinated but wear my mask and keep my distance from strangers. Not only is the vaccine not 100 percent, even if we who are vaccinated don't have bad symptoms we could have enough viral load to spread it to others who are or are not vaccinated.

dukemunson Aug 25, 2021 12:18 PM
COVID-19 Vaccine Gets Full Federal Approval

Loose - As per all science and logic, COVID will become endemic. What you are advocating for is authoritarian madness. Covid is here to stay...silly over the top fantasies of punishments for people who don't get the vaccine is nutty (and not "ahead of the curve", unless you view China as the model country).

Voice of Reason Aug 25, 2021 11:45 AM
COVID-19 Vaccine Gets Full Federal Approval

Loose, you need to stop watching tv and reading social media, your comment reeks of for-profit media propaganda, misinformation and scapegoating, and your totally blind to it.

sacjon Aug 25, 2021 11:01 AM
COVID-19 Vaccine Gets Full Federal Approval

JAK - you guys all realize, don't you, that mandatory vaccines doesn't mean the government will come to your house, hold you down and inject you, right? All this means is that if you don't get vaxxed, you will be denied entry into certain places, have to pay a fine or both. No one is going to FORCE vaccinations. People who continue to choose to ignore the experts will just be held accountable (gasp!) for their actions. Bootstraps and all, personal responsibility for one's own actions, or inactions, will be the rule. Don't want to be vaxxed? Fine, find a different job, workout at home, order take out instead of dine-in, watch Netflix instead of going to the Metro 5, homeschool your kids, etc etc. Choices have consequences. I would never support forced vax, but fully support consequences for those who choose to listen to conspiracy theories on YouTube over medical experts.

LooseCannon Aug 25, 2021 10:42 AM
COVID-19 Vaccine Gets Full Federal Approval

DUKEMUNSON,

The only dystopia that concerns me right now is endless pandemic, and bodies piling up on top of bodies because a significant part of our population refuse to get vaccinated, believe in conspiracy theories, unfounded rubbish, won't listen to credible scientists, and hold their individual freedoms to be more important than the greater welfare of the community.

I am ahead of the curve. I was on here talking about the necessity for vaccine mandates months ago, and now it's happening, but not in know-nothing red states like Texas or Florida, or the white supremacist enclaves in Idaho. No, the vaccine mandates are becoming popular in New York and California, among other liberal bastions. So who's the fascist now?

We have held their hands and commiserated with the vaccine hesitant for months, and it isn't working. The era of the carrot has to give way to the era of the stick.

jak Aug 25, 2021 10:31 AM
COVID-19 Vaccine Gets Full Federal Approval

LOOSE, I am no antivaxxer. In fact you might call me an anti-antivaxxer. That said I am going to have to side with VOICE on most of his points in this thread. The kind of mandates and sanctions you advocate for might work well in a draconian dictatorship (limited available evidence would suggest that it has in parts of China though it’s long term effectiveness at mitigation of Covid19 spread is harder to substantiate) but it is not suited to any semblance of a democracy.

Voice of Reason Aug 25, 2021 07:05 AM
COVID-19 Vaccine Gets Full Federal Approval

Loose, you’ve lost it. Forcing someone to inject something into there body is no where near the same as requiring insurance. I can’t believe I even have to right that. To your question at the end, YES! Absolutely! You can and should be forcibly quarantined with an active Covid infection. How we completely went off the rails in responding to covid is the forced quarantine of everyone, even those not batteling an infection.

LooseCannon Aug 25, 2021 02:09 AM
COVID-19 Vaccine Gets Full Federal Approval

VOR: If you drive a car without insurance, you will likely be fined. Re-offend and the penalties will become more severe. Kill someone while driving around uninsured or without a license and you will face jail time.

We should implement something similar with respect to the unvaccinated, ratcheting up the penalties if the recalcitrants refuse to get immunized, culminating in house arrest with ankle bracelets, and loss of privileges and benefits.

People claiming religious exemptions should be forced to undergo regular testing at their own expense. Their insurance premiums should be raised dramatically.

No one has a sovereign right to infect other people with a deadly virus. If a person walks around with an active case of TB, he will be forcibly quarantined. Why should COVID be any different?

Voice of Reason Aug 24, 2021 10:47 PM
COVID-19 Vaccine Gets Full Federal Approval

@9:48 prohibiting all of those absolutely irresponsible things you listed is not comparable to forcing an action upon someone, in this case, forcing someone to inject a pharmaceutical product they don’t want. I can’t believe so many here think I’m the one with the extreme views! It was my choice when I was vaccinated.

a-1629866919 Aug 24, 2021 09:48 PM
COVID-19 Vaccine Gets Full Federal Approval

FREEDUMB! People should be allowed to drink and drive, and not get vaccinated without a medical reason, and detonate bombs in their back yards, and dump garbage wherever they want! Public health and safety laws are infringements on your personal liberty to be as stupid as you can be!

Voice of Reason Aug 24, 2021 08:50 PM
COVID-19 Vaccine Gets Full Federal Approval

Loose, your calling for the imprisonment of people that don’t want the vaccines (for many different reasons each personal to themselves). You think people should loosed their jobs, benefits, social security and jail! If you have been vaxxed covid is not a life threatening issue for you, but you push for this on everyone not vaxxed? At the same time, your recommending 12 year olds and immunocompromised to wear masks, as of that will protect them, which is backed up by zero science whatsoever. Mask don’t protect you, they protect others in case your sick even if you don’t know it. Even Fauci has said this, even with all the new covid data we’ve learned, and is common medical knowledge. In the same thread you’re calling for people who refuse the vaccine to lose their retirement and be put in jail, you demonstrate a complete lack of knowledge on covid transmission and protection. And people here thumbs up it! I know I’m not alone here in thinking this is absolutely nuts!

ChemicalSuperFreak Aug 24, 2021 06:56 PM
COVID-19 Vaccine Gets Full Federal Approval

Hi SACJON. It's my belief that a booster of the same vaccine is a bad idea, and than a new vaccine that accounts for the amino acid substitutions in the spike protein binding domain is required, particularly as this virus continues to evolve into new variants. For those with poor responses to their initial vaccination(s), a booster may help. If that's suspected, I'd think it's wise to perform a titer on people before prescribing another dose. Overtraining the immune system with old vaccines might come at a huge price if the person already has an adequate titer of antibodies. I'm referring to antigenic imprinting here, which could leave a person's immune system worse off when it comes to the next variant surge. As far as "yeah no one ever said the vax was 100%", that's not exactly true, because many vaccinated individuals are walking around with that exact belief in their minds. I've seem comments from health officials, politicians, and people here on Edhat overselling the vaccines, much to society's determent as evidence by the surge of breakthrough cases. It's going to take much more vigilance than just rolling your sleeves up for a shot.

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