COVID-19 Vaccine Gets Full Federal Approval

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 to find a clinic near you.


Written by Anonymous

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  1. 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.

  2. CSF – yeah no one ever said the vax was 100%. If we have to get boosters, ok then we do. I get a flu shot every year. Thing is, this virus is going no where and we have to do everything in our power to slow it. Vax and mask. People are refusing to do one or the other, many times both. This needs to stop if we want to get back to something resembling “normal” any time soon.

  3. WORTHY TO NOTE: You failed to mention the amount of infections (and deaths) are way down. If not for this particular VACCINE, my friend, we would have been wiped out by now, if not from sickness, from a collapsed economy. Thank our past president for his efforts in getting it out in record time. The naysayers said we wouldn’t have a vaccine until May or June of this current year!… TAKEN FOR link ChemFreak provided ==> Although these interim findings suggest a moderate reduction in the effectiveness of COVID-19 vaccines in preventing infection, the sustained two thirds reduction in infection risk underscores the continued importance and benefits of COVID-19 vaccination.

  4. The virus protects against serious consequences in the event of infection if you are vaccinated. You won’t have to worry about hospitalization, serious illness, and death, if vaccinated. You may get mild cold symptoms. Big freaking deal.
    Let’s have a broad vaccine mandate for everyone in order to keep your job or enter a business or public venue.
    12 years old and younger/immunocompromised, wear your masks. Be vigilant.
    We should explore the possibility of criminalizing people who refuse to get vaccinated. But for the moment, they should fear for their jobs, and be prevented from entering any public indoor space.

  5. This could be used as a model for people refusing to be vaccinated:

    Common Penalties for Driving Without Insurance:
    Fines of up to $5,000;
    Suspended driver’s license;
    Suspended vehicle registration;
    License and registration reinstatement fees;
    SR-22 requirement;
    Jail time;
    Mandatory community service;
    Vehicle impoundment.
    If you cause an accident while driving without insurance, you will be financially responsible for all of the damages. Allowing your car insurance coverage to lapse also classifies you as a high-risk driver, which will make coverage more expensive in the future.

    Penalties for Not Being Vaccinated:
    Fines of up to $5,000;
    Suspension of work and public benefits, including unemployment benefits, Social Security, and food stamps;
    Suspension of entry into indoor public environments;
    Reinstatement fees;
    Proof of COVID vaccine requirement;
    Jail time;
    Mandatory community service;
    Suspension of travel privileges.
    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.

  6. 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.

  7. 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!

  8. 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!

  9. 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?

  10. 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.

  11. 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.

    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.

  13. 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.

  14. 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.

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