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* FDA press release…
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and 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 the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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 Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
posted by Rich Miller
Monday, Aug 23, 21 @ 9:22 am
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Next anti-vaxxer excuse coming in 3… 2… 1… I predict it will be “they rushed it.”
Comment by Ron Burgundy Monday, Aug 23, 21 @ 9:30 am
Great news. Bring on more vaccine mandates and boosters, so we can have the best shot (no pun intended) at beating the pandemic.
Comment by Grandson of Man Monday, Aug 23, 21 @ 9:31 am
Yesterday=”Experimental, not FDA approved”
Today: Don’t bother the GOP and other antiivaxers. They’re busy moving goal posts.
Comment by Don't Bloc Me In Monday, Aug 23, 21 @ 9:34 am
But, but, but… I don’t wanna take the mean old vaccine. S/
Comment by Bruce( no not him) Monday, Aug 23, 21 @ 9:36 am
Bring on the mandates (banned punctuation)
Comment by wildcat12 Monday, Aug 23, 21 @ 9:38 am
Tired: The vaccine is not FDA-approved.
Wired: I don’t trust anything that the FDA approved so quickly.
Comment by SAP Monday, Aug 23, 21 @ 9:41 am
Let’s start with the mandates.
Let’s start being smart and deciding that getting back to normal in any pandemic has been vaccines.
Comment by Oswego Willy Monday, Aug 23, 21 @ 9:43 am
C’mon Moderna……….
Comment by Sayitaintso Monday, Aug 23, 21 @ 9:47 am
==Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.==
Do any of you have middle school, high school or college age sons or grandsons?
Comment by Responsa Monday, Aug 23, 21 @ 9:51 am
“They’re busy moving goal posts.”
They will have plenty of free time to move goal posts without jobs, if they refuse their employer-mandated vaccinations or frequent testing (if that’s an allowable alternative). We’ll see how the personal responsibility folks handle this.
Comment by Grandson of Man Monday, Aug 23, 21 @ 9:53 am
Anti-vaxers, welcome to a whole new world.
Comment by Flyin' Elvis'-Utah Chapter Monday, Aug 23, 21 @ 9:55 am
-Do any of you have middle school, high school or college age sons or grandsons?-
Yes. And they were vaccinated and wanted to be. No question about it. I think they got Moderna, however.
Comment by Ron Burgundy Monday, Aug 23, 21 @ 9:59 am
=== Do any of you have middle school, high school or college age sons or grandsons?===
If one does or doesn’t, you anti-vaxx thinking will continue to hurt the country and help keep hospitals, ICUs, and first responders tired…. Because… another “thing”
Comment by Oswego Willy Monday, Aug 23, 21 @ 10:01 am
Mine son is 18, he wanted a shot ASAP. Pfizer 2 shots is what he received in March. Played soccer and ran track.
Comment by BTO2 Monday, Aug 23, 21 @ 10:07 am
=== Do any of you have middle school, high school or college age sons or grandsons?===
Yes and I had him vaccinated as soon as humanly possible because I care most about his well being and COVID is a much much much much bigger risk. And he is fine thank you for your sincere concern.
Comment by illinoyed Monday, Aug 23, 21 @ 10:09 am
===Do any of you have middle school, high school or college age sons or grandsons?===
Yes, and I got him the shot the day after he turned 12. Cake and ice cream followed by a Covid shot. He declared it the best birthday ever.
Comment by Suburban Mom Monday, Aug 23, 21 @ 10:13 am
Yesterday’s GOP: We need to get rid of government red tape holding everything up.
Today’s GOP: The review process cannot be rushed.
Comment by Asteroid of Caution Monday, Aug 23, 21 @ 10:13 am
Responsa, with the “won’t someone think of the children” routine.
Bub, mandates are coming, as quickly from the private sector as public. Kick and scream till your heart’s content.
Comment by Flyin' Elvis'-Utah Chapter Monday, Aug 23, 21 @ 10:15 am
=Do any of you have middle school, high school or college age sons or grandsons?=
Yep, 8th grader and fully vaxxed. Waiting on 12 and under now.
If your honestly paying attention, the risks of long COVID are far greater than myocarditis and pericarditis.
Even though this vax is fully approved, I still can’t wait for those I know that are opposed to still choose to used non-FDA approved drugs to “treat” COVID. Looking at the ivermectin crowd.
Comment by Cool Papa Bell Monday, Aug 23, 21 @ 10:16 am
The anti-vaxxers want nothing more than to gin up ridiculousness that seems “thoughtful” but in actuality the anti-vaxxers want nothing more than to have people question health and science while at the same time being absolute phonies to… health and science.
This is the time. You wanna know and see those who will *never* be persuaded… listen who *still* aren’t “satisfied”.
Enter mandates.
Comment by Oswego Willy Monday, Aug 23, 21 @ 10:17 am
Kind wish the COVID vax would turn people purple or green or polka dotted for two weeks.
It would show the grift going on with a certain group of people trying to sow distrust all the while protecting their health and their families health. And proving they don’t give a rip about anyone else.
Comment by Cool Papa Bell Monday, Aug 23, 21 @ 10:23 am
==Next anti-vaxxer excuse coming in 3… 2… 1… I predict it will be “they rushed it.”==
They did not waste any time. This is how Fox News led the breaking news, couched in the plausible deniability of “some people are saying” and “we’re just asking questions.”
https://twitter.com/LisPower1/status/1429808635086057473?s=19
Comment by Roadrager Monday, Aug 23, 21 @ 10:25 am
My high school daughter and I both got our Pfizer shots as soon as they were available. Anna plays soccer and was kicking for football this past Spring. We got our first shots during the morning before a football game and the only side effects were we both had sore arms on the long drive back from Rantoul after the game. We will both get boosters as soon as they are available.
I am happy that the private Catholic school Anna transferred to for her senior year is very pro-mask and pro-vaccination. It is a nice change from her prior high school and I am looking forward to sports photography as the very HS sports seasons take off.
Comment by former southerner Monday, Aug 23, 21 @ 10:26 am
“The anti-vaxxers want nothing more than to gin up ridiculousness that seems “thoughtful” but in actuality, the anti-vaxxers want nothing more than to have people question health and science while”
It seems like you have a preconceived idea of who these “Anti-vaxxers” are or what their ideology may be. There are many folks that have a hesitancy to get Vaccinated, and as highlighted by WTTW they are not just Eastern bloc types.
https://news.wttw.com/2021/08/22/will-vaccine-mandates-shut-out-unvaccinated-black-chicagoans
Comment by Donnie Elgin Monday, Aug 23, 21 @ 10:28 am
@Former southerner
Have a season, very hopeful that strong masking and a decent vaccination rate in Illinois can keep the fall sports intact.
Comment by Cool Papa Bell Monday, Aug 23, 21 @ 10:32 am
And the older the child gets vaccinated, the more likely the MMR vax will cause febrile seizures. The DTaP can cause high fever and seizures.
The medical community knows about side effects and any doctor who cares about their patients will be watching out for them.
Comment by Cheryl44 Monday, Aug 23, 21 @ 10:32 am
Tell the GOP the vaccines were not rushed. They’ve been in progress since the patents were applied for in 2002 and 2003.
Comment by Uncle A Monday, Aug 23, 21 @ 10:34 am
I refuse to call it Comirnaty. Terrible name.
Comment by Excitable Boy Monday, Aug 23, 21 @ 10:35 am
==Do any of you have middle school, high school or college age sons or grandsons?==
Yep. I have two. And I had both of them get the vaccine.
Comment by Demoralized Monday, Aug 23, 21 @ 10:36 am
===It seems like you have a preconceived idea of who these “Anti-vaxxers” are ===
There is a certain type of person who is always looking for loopholes when it comes to race.
FACT: 48 percent of the population here is unvaccinated.
FACT: Illinois Black population is 14.6 percent.
Comment by Rich Miller Monday, Aug 23, 21 @ 10:47 am
- Donnie Elgin -
(Sigh)
From your own cite.
=== Karen Freeman-Wilson, president and CEO of the Chicago Urban League, says that while accessibility still remains an issue for some Black Chicagoans, she believes that misinformation is at the heart of many people’s hesitancy.
“There was so much misinformation thrown at the public initially it is hard to cut through with the accurate information,” she said. “And then the fact that it’s a changing virus also, I think, attributes to the hesitancy.”
But Freeman-Wilson says that while mandates might create barriers for those reluctant to get vaccinated, the health and safety of the community must come first.===
It’s the misinformation that is seemingly driving the lower numbers.
Charles Barkley in Birmingham having a vaccination drive is predicated on the misinformation not the “anti-vaxx silly”
You’d understand that if you actually read your cite.
Geez, Louise.
Comment by Oswego Willy Monday, Aug 23, 21 @ 10:53 am
@Cool Papa Bell
Thanks and hoping for a fairly normal year for sports. Hopefully by girls’ soccer season in the spring, everything will be close to normal. Football could be touch and go with last minute schedule changes but I am looking forward to giving the cameras and lenses a nice Friday night workout.
Comment by former southerner Monday, Aug 23, 21 @ 11:02 am
- they are not just Eastern bloc types. -
What’s that even supposed to mean? If black people made up the majority of anti vaxxers you think those of us to the left on the spectrum would suddenly say “oh, we’ll that’s ok then.”
As pointed out by others that’s not actually the case, but still what an odd worldview you must have.
Comment by Excitable Boy Monday, Aug 23, 21 @ 11:08 am
As Ted Leverenz would say during lulls on the House floor, “Now?”
Comment by Lt Guv Monday, Aug 23, 21 @ 11:08 am
===Do any of you have middle school, high school or college age sons or grandsons?===
Yes, and he’s vaccinated.
See, your choice isn’t between the risk posed by the vaccine and no risk at all. Your choice is between the risk posed by the vaccine and the risk posed by COVID. The risk posed by COVID is empirically greater, that’s why we choose the vaccine. If you’re going to tie yourself in knots over risks, then factor ALL Of them into account, using real science, then make your decision.
Comment by LakeCo Monday, Aug 23, 21 @ 11:08 am
I’ve truly been amazed at the level of animosity and personal attacks leveled at me this morning for nothing more than copying verbatim the new warning from the FDA Pfizer approval announcement concerning some young men. Geez. Best of health to you all and your families.
Comment by Responsa Monday, Aug 23, 21 @ 11:08 am
==There are many folks that have a hesitancy to get Vaccinated==
That’s fine, just don’t take a hospital bed for Covid symptoms while you (or those close to you help) overcome your hesitation.
Comment by Jocko Monday, Aug 23, 21 @ 11:08 am
=Do any of you have middle school, high school or college age sons or grandsons?=
Yes, my son is in high school and got the pfizer vaccine. He had the same reaction he has had to vaccines since infancy. Short term fever. Same as me.
=It seems like you have a preconceived idea of who these “Anti-vaxxers” are=
For good reason.
Comment by JS Mill Monday, Aug 23, 21 @ 11:09 am
I cant wait for the irony of these anti-vaxxers who what to keep the economy opened up to help businesses, shut out from the very businesses because said businesses require vaxx proof.
Comment by Nagidam Monday, Aug 23, 21 @ 11:10 am
=== than copying verbatim the new warning from the FDA Pfizer approval announcement concerning some young men.===
Yeah. ‘Bout that.
Those pharma commercials with 15 seconds of “warnings” for things like… high blood pressure, insulin… it’s known that that betterment of life… means these drugs are needed for health.
If you think… if you *think*… “Whadda bout the children” is a good take during a global pandemic.. you’re the same type that are keeping these vaccines from fighting and saving lives.
Comment by Oswego Willy Monday, Aug 23, 21 @ 11:13 am
-nothing more than copying verbatim the new warning from the FDA Pfizer approval announcement concerning some young men.-
Don’t forget asking a question to commenters that seems to imply they were being reckless with their young male family members’ health. Can’t imagine why anyone would react to that.
Comment by Ron Burgundy Monday, Aug 23, 21 @ 11:18 am
=== Never gonna happen, south of I80 anyway===
Prolly start with schools.
Jobs are not a guarantee, and lots of state jobs downstate.
Don’t look forward the courts to stop mandates. Ain’t gonna happen.
Also, your ridiculous “diversity” swipe is like complaining that “alternative facts” are real things
I know, I know… “… ‘Merica”
Comment by Oswego Willy Monday, Aug 23, 21 @ 11:21 am
===Don’t forget asking a question to commenters that seems to imply they were being reckless with their young male family members’ health.===
Sometimes asking a question gets an undesirable answer.
Comment by Oswego Willy Monday, Aug 23, 21 @ 11:22 am
=== Never gonna happen, south of I80 anyway===
Sure because all the universities and Fortune 100 companies are all north I-80. Save me on the geography shaming. State Farm, Caterpillar, John Deere, U of I, ISU, Country Financial, GROWMARK, Rivan … all “downstate”.
Comment by Cool Papa Bell Monday, Aug 23, 21 @ 11:36 am
Hope Moderna gets full approval soon then open all to the under 12 crowd.
At the same time please stroll through the comments attached to this ivermectin article from Rolling Stone.
https://www.rollingstone.com/politics/politics-news/fda-horse-dewormer-covid-fox-news-1215168/
Yeah, big pharma only after the big vax money, ‘I did my research’, ivermectin is well studied, doctors are fools, and India cured covid with ivermectin. Unbelievable ‘I know the right info’ stuff.
Comment by zatoichi Monday, Aug 23, 21 @ 11:40 am
I don’t think this is going to have a meaningful impact on the people who have decided to be “vaccine hesitant.” Those are the folks that are driving our current public health emergency and it is unfortunate that the GOP opened Pandora’s box on the pandemic in order to score cheap political points with people they didn’t need any more points with in the first place.
Comment by Candy Dogood Monday, Aug 23, 21 @ 11:49 am
All the arguments by the anti-vaxxers/anti maskers shouting “liberty” is really just a euphemism for selfishness.
Comment by Tommydanger Monday, Aug 23, 21 @ 11:51 am
So what are your excuses for not getting shots now? And by the way, the number of people given all the U.S. Covid vaccines under the EUAs was far, far larger than any standard trials for new drugs or vaccines. More people are surviving infections with mild cases, not being hospitalized or dying from it. If we can’t stop Covid outright cold, we can make sure more people are going to survive without any long-term effects. So roll up your sleeves, Americans, and get the vaccines before it’s too late for you or someone else.
Comment by thisjustinagain Monday, Aug 23, 21 @ 11:57 am
Responsa-come down from your cross…it’s been done.
You asked a question, and got responses you didn’t like.
Don’t pout now.
Comment by Flying Elvis'-Utah Chapter Monday, Aug 23, 21 @ 12:14 pm