FDA approves new Covid vaccines for Pfizer, Moderna

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While characterizing them as different from the boosters people have received to ward off Covid, the Food and Drug Administration approved a new Covid shot on Monday, one that will be pushed to the public along with their seasonal flu vaccines.

The FDA is attempting to normalize the Covid shots as the same as other vaccines that people get throughout their lives, starting in infancy.

The FDA says the new vaccines are formulated to more closely target currently circulating variants and to provide better protection against serious consequences of Covid-19, including hospitalization and death.

“Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5,” the FDA said in its statement.

The shots will be given to people 5 years of age and older regardless of previous vaccination with a Covid-19 formula, if it has been two months since their last dose of any Covid-19 shot.

Also:

  • Individuals 6 months through 4 years of age who have previously been vaccinated against Covid-19 are eligible to receive one or two doses of an updated mRNA Covid-19 vaccine (timing and number of doses to administer depends on the previous Covid-19 vaccine received). 
  • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech Covid-19 Vaccine or two doses of the updated authorized Moderna Covid-19 Vaccine.
  • The FDAsays it is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment says it demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
  • Individuals who receive an updated mRNA Covid-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA Covid-19 vaccines as described in the respective prescribing information or fact sheets, the agency says.
  • The updated vaccines are expected to provide good protection against Covid-19 from the currently circulating variants, the FDA says. “Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of Covid-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.”
  • The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Sept. 12, to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals. 
  • Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.

“Vaccination remains critical to public health and continued protection against serious consequences of Covid-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech Covid-19 vaccines are no longer authorized for use in the United States.

62 COMMENTS

  1. Never had it, never will. If I had a kid, they would never get it either. This idiocy is like a pandora’s box of income to the drug companies that will never be closed. The amount of “vaccines” being advertised for myriad different ailments is almost constant on any television channel. Untested, unreliable, and ineffective describe all the Covid vaccines.

    • All, there will be more Covid conversation/discussion on October 13/14 with Dr Peter McCullough as the keynote speaker. Register: ‘www.alaskacovidalliance.com.

  2. Both stocks, PFE and MNRA, are at 3-year lows. With the current chaotic circus in full-swing, these two stocks might very well appreciate handsomely within the near future, potentially maximizing your investment.

  3. It will be interesting to see how many people get the new jab. I’m in Santa Monica, where people couldn’t get enough, and are now dropping like flies. Several healthy friends are dead, cardiac failure. All got the jabs.

    Safe and effective!

  4. Uh, Let me guess…Big Pharma is still immune from any and all liability from any repercussians or injury from the “new” safe and effective thoroughly tested FDA approved covid “vaccine” which by definition prevents anyone who is vaccinated from getting covid.
    AND those who refuse to vaccinate will be responsible for spreading the virus as well as “causing “the death of those who suffer the consequences of the covid virus.

  5. If anyone is stupid enough to do this after what we all know, just put your head in the sand and get out of the way. No person with a brain is going to buy the Federal Death Administrations bs nor the CDC. They are both corrupt!

  6. Well, folks, I’m writing this from isolation, due to the fact that I’m recovering from my first-ever case of Covid.

    Having successfully avoided infection for the past 4 years, I can now report that my case is nothing more than a moderate head cold – about a 4 on a scale of 10, if 10 is the worst cold I’ve ever had.

    Why have I been so lucky? One word: vaccines. I’ve taken the full set that are appropriate for my age group, and will continue to do so. I’ll also encourage others to do the same.

    I’m happy to report that in spite of having 6 injections to date, I’ve not had a single clot, heart issue, or other adverse effect, nor have I detected any microchips in my body.

    These vaccines are safe, effective, and they work just as advertised. So at long last, drop your anti-vax nonsense and conspiracies, open your hearts, and accept the good fortune that having these vaccines available to you is.

    And finally, Madame Editor, thank you for putting out a Covid vaccine story that is factual, straight down the middle, and devoid of an anti-vax tone. No doubt the forthcoming comments will handle that part.

    • Wow my story is almost the same as yours…havent had covid at all for the past four years.
      Why have I been so lucky? Didnt take any vaccines. Neighbors to the west were both very sick with covid for a week the day after they contracted it from the vaccine. Neighbor to the east was sick for a month with severe heart issues never experienced before within days after vaccine. His Dr said it was directly related to Myocarditus. (He thought he was going to die) Dr Malone suffered the same heart condition and tried to warn the public of the risk but was censored.
      These vaccines are not as safe and effective and work just as advertised because EVERYBODY is not the same.
      Everyone has a different reaction to the virus as well as the vaccine.
      If the vaccine was totally safe for everybody there would not be a release of liability clause protecting big pharmas profits from their heavyweight investors (Pelosi Venture Capitalist Investment Group)
      Swine Flu vaccine was not safe for everyone as it was discontinued weeks after introduced due to severe paralysis leading to death was encountered.
      I simply wont insist everyone do as I do or think what I think based on my experience.
      Nor will I comply with any government mandates.
      I encourage everyone to do their own homework and research and do what they think is best for themselves and not for someone elses retirement portfolio.
      We are not sheep. We are individuals. God blessed America.

        • Ok Dr Dawg. Have you a prognosis for all the sheep or just the ones who dont care to follow your hollow theory.
          Go ahead and smoke more of whatever you are having. I m not interested in your sales pitch on phony vaccines.

        • Interesting observation WTD, which raises the following question: In the intervening years since the administration declared Covid over, have you NEVER had a cold, sniffles or cough? Frankly I seriously doubt that. So how do you really know if this was your first brush with Covid? Unless of course you take a test every single morning to make sure …
          (I bet DrDan can refer you to a great psychiatrist to deal with your hypochondria issues)
          Is it not possible that you have had mild forms and developed some immunity??? Just wondering….
          Anyway in the end the only thing we all want from our government is a bit of honesty. If the CDC had come out and said:
          We have this new form of an injection. We think it may work to lessen the impact of Covid. Because we rushed it to you, we have very little data on side effects for any age group and NO data on long term impacts. However we think it will benefit certain age groups with moderate to severe health issue.
          This could have started an honest debate not only between patient and doctor, but also amongst physicians to compare notes and advise the CDC. As a parallel avenue other medications could have been explored.
          Instead it was “our way mandated” and anything that hints of questioning was declared misinformation.
          You go ahead and do as you see fit, but the reluctance of the powers that be to come clean and be honest, gives me pause.

    • Believe what you want to believe. I haven’t had any of the jabs and also had the covid early in the outbreak. And like you, WT, it was a mild like cold. How do you know that you don’t have any heart issues yet? Are you having all kinds of tests done on a regular basis to make sure you’re not developing heart problems? Or just looking in the mirror? But I do wish you well with all of the future jabs you’re gonna get. I’ll not be joining you.

    • WTD I am glad you are well and have no ill effects from either the shots or the disease.

      Anecdotal experiences are important, but forgive me if I do not base my actions on your advice to get shots that have no actual track record of REAL effectiveness and human trials.
      Since 98% of individuals experience Covid the way you did (a head cold) and not only survive but get better without intervention (or previous injections), attributing your mild disease process to this shot seems unsubstantiated at best. This seems especially pertinent considering the Covid shots target a very specific spike protein of a very specific variant. It seems highly unlikely that they are effective at all against the latest mutation of the virus. It’s like saying “I drank orange juice every day and my cold got better in 7 days”. Correlation is unrelated to causation.
      In the intervening years, it has become more and more apparent to most that age, genetics and co-comorbidities ARE the overriding factors for reasonable determination of disease outcome regardless of vaccination status.

    • You got the shot, got Covid, and say the vaccine works? Was it supposed to give you Covid?

      I’m laughing so hard I was afraid I might wet myself.

      I realize you come here to troll, but really dude-back away from the bong.
      You’ve long moved from amusing to whatever you are now.

        • I have a vaccinated friend who died from a heart attack while suffering from the disease, and others including myself whose heart health got worse after the clot shots. And they have the nerve to claim “safe”? By previous FDA regulations “the agency’s rigorous scientific standards” are none of that. They have no basis for claiming safety or adequate testing or efficaciousness.

          • Actually they do if you actually care to read a peer-reviewed study rather than relying on your own anecdotal evidence.

            ‘https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(23)00071-6/fulltext

      • That’s like saying someone who got the flu shot, then got the flu, must have gotten the flu from the shot, which is utterly ridiculous, and impossible. Nobody gets Covid from the vaccine and the shots we have now are not supposed to keep you from getting Covid, just reduce the risk of severe illness and/or death.

    • I, too, am glad that your are well and your case was mild.

      Following your same line of logic, I had a very mild case of Covid about a year ago for the first and only time. A day of fever and sniffles. 2 on a scale of 10 with 10 being the worst cold I’ve ever had. I’ve never had any of the shots. Since my case was only a 2, was yours twice as bad? And was it because you took all the shots?

      Let’s level for a minute: there is no way for anyone to know where or not they benefited from the “vaccinations” or by not taking the shots. Adequate testing usually takes many years — decades in some cases — and randomized double-blind scientific tests have never been completed on a full sample of the population with any shot designed against Covid. Considering Covid risk factors are low for people in my age/gender/health/race demographic and people in the same age/gender/health/race demographic are dying at rates many times higher than normal in the last two years and after taking the shots, I’m not taking these vaccines and I’ll resist anyone who wants to force this or any medicine (especially the experimental kind) on anyone else.

      Again, glad your are physically healthy following your bout with Covid. Now I hope you find mental healing from nonsense unscientific totalitarian leftist propaganda.

    • Lol! The echo chamber! I thought it had collapsed, but the dog just showed that it is alive and well. Haha Enjoy your jabs for as long as you live dog.

      • Just remember, Ginny, a dog lives 7 years for every human year.
        And I’m guessing that a mRNA-injected, (so-called) ‘vaccinated’ dog lives significantly more years per human year than that.

    • My story is almost the same as yours. I had a very mild cold a little over a year ago. I get them occasionally. On a lark I used one of those home test kits that were being handed out for free at the library the day before. Much to my surprise, I tested positive. Not trusting the results I went in for a clinical diagnosis and again tested positive. On the 1-10 scale, it felt like a 1. Since then my vaxxed and boosted wife has been diagnosed twice with covid and had it much worse than me. I took no special precautions either time and did not get it again, probably due to now having natural immunity. And speaking of precautions, since this all began I have never worn a face diaper except when absolutely mandated, such as on an airplane. Once everything opened back up in May 2020 I’ve been out and about just as in the past. Not only did I refuse the covid vaccine, I refuse all others. Nothing gets injected in me, period. Now my wife regrets ever getting the vaccine, as she has been much sicker than in the past. I’ve heard the same from others I know. I’ve never heard anyone I know say they wish they had gotten the vaccine.

  7. It’s nice that it will be free for uninsured. Insurance is quoted at $785.00/mo for me with no meds or existing conditions, so it’s hard to afford. Getting this will hopefully lessen the chance of having to take a week or two off work. Living paycheck to paycheck I can barely afford to take a day off, let alone that long. Once you become homeless here people assume you choose to be and a lot of doors close in society, so paying rent is top priority over food right now. Hopefully either the rent stops going up or the pay starts going up. Lots of us are a missed paycheck away from the brink.

  8. I am not anti vaccine but am selective based on need and effectiveness. Given I had a very rough case of Covid, after two vaccines and before eligible for the third, I am a little skeptical of effectiveness. I ended up with heart issues from Covid. Covid is indeed dangerous to contract foe some people and if an effective vaccine can be developed that is truly effective then great. I might get it, simply because I am a tad wary of what might happen if I get Covid again. I have no comorbidity, am a runner and have been for 40 plus years, work out daily and am fit and not overweight. No health issues but still ended up with heart inflammation, arrhythmia, and now have a heart murmur I never had. Thankfully recovered and nothing life threatening. Covid certainly is not just a cold but I am not going to live my life in fear, nor in a mask. Vaccines should be a personal decision only.

  9. NEVER GET THESE SHOTS!!! In my opinion, the only thing they will do to you, is to make you sicker and probably more deadly. Stay away from them!!! Your body will take care of you, IF you stay away from these shots!!! All these people want to do is to make more money off of you, while they gamble with your health.

      • Greg, yours is a specious argument.
        You basically imply that with Covid nobody would die IF they get that shot. That fact simply isn’t true. People died AFTER they received a shot, FROM/WITH Covid. It isn’t one size fits all. You do you and quit laying on the fake guilt trip.

        • You’re not supposed to disclose this. In many, many places people who died WITH Covid were recorded as dying FROM Covid.

          Why? More federal funding.

          I’m old. I have many of the issues which come of old age. Arthritis among them. When I die, barring accident, I will die with these issues. Not because of them.

          • Greg, not sure what you mean by that, since unlike you I do not advocate for people to follow my words, but instead repeatedly have stated that it is a personal decision for each individual. You lay the deaths of people at my feet and I vehemently reject that notion, as each of us makes their own choices and has to live by the consequences of such. Sometimes you can do everything right and in the great lottery of life still draw the proverbial genetic short straw.

    • My wife has been much sicker since being vaxxed and boosted. And she’s had covid twice since. I never took the needle and had one very mild case of covid. She’s sorry she ever took the needle and I’m darned glad I never did.

  10. Time media, politicians, pharmaceutical, etc. to admit that the AMA, FDA, CDC, W.H.O, etc. are gaslighting the World. Obumer legalized propaganda. CIA, FBI, NSA, FEMA are not our friends. We are in live war theatre.

    In the end, facts and truth will prevail. Fool me once shame on me, fool me twice shame on them. Don’t be fooled by the lies. If any vaccine was safe and effect, why do the vaccine manufacturers demand immunity? If vaccines are safe and effective, why do you have to have boosters? It is all about the money and control.

  11. Follow the money because we now know it’s not about good sound science but about the money. My self and friends all will not get the jab.

  12. Why can’t it simply be called a “shot” as in flu “shot” considering every year a new serum is developed for the “new” flu strain. Seems that exactly the road traveled with the C19 vaccine, ops I meant “shot”.

    • After the government spent all that time and money to redefine the definition of a vaccine so the covid “vaccine” could meet the definition of a vaccine?

  13. But what about the money?
    Anthony Fauci got very rich in a very short period of time since covid started until Dr. Rand Paul started asking him some very direct questions that he couldnt answer whatsoever because “He couldnt remember”.
    “It happened so long ago I simply dont know any of answers to the questions you are asking me”?
    I wonder if a little “waterboarding” like they used on the terrorists at guantanimo would help his memory along?
    That wouldnt be near as cruel as what He and his “team” exposed those beagles to after they removed their bark capabilities so they wouldnt have to listen to them in their misery.
    He is a pathetic little man who belongs at Gitmo for the rest of his years.
    Who in the heck is supposed to get rich as a so called expert during a worldwide pandemic? Only a crooked little thief.

  14. My grandmother always gave me Hot Toddy’s when I was sick. So I’ll just stick with that. During the plandemic I drank a lot of Bourbon (probably too much)and never did get sick. Choose wisely for you can never go back. Just like the Mark of the Devil.

  15. Simple question. If I get the newest shot and my neighbor catches the same variety on the same day , who has the longest immunity into the future and how long? You never told us before and not now because natural immunity is best. And unless I am in high risk group Covid shots are foolish.The industry is full of liars chasing $.

  16. At the end of the day, it boils down to this.

    -there are some people who bought the “vaccine” bit hook, line, and sinker. They are by faith and ego unwilling to admit the actual science doesn’t bear it out.

    Covid was a really bag bug that scared a whole bunch of people. Politicians, Trump included, did what they do best. Overreact and find a way to use the overreaction to their benefit.

  17. Something I’m truly tired of is the virtue signaling from both sides.

    Get the shot, don’t get the shot, and shut up about it.

  18. Had an uncle who carried a briefcase filled with all the drugs (medication) that his very expensive doctor told him would ensure his longevity. Took his pills like religion. But that was his choice. I offered no advice, as he was very intelligent. Don’t know if it extended his time on earth but he sure wanted to believe it would. Everyone would like to believe that there is a magic pill for anything. Look at the aisles of crap for the common cold. All designed to give you confidence of fixing it with pill. If you think the magic shot will save you, by all means take it for your own piece of mind. And if you think a mask will save you, wear one with confidence. But please leave the rest of us out of it. Everyone deserves to have their own choice and my choice doesn’t effect anyone but myself, no matter how hard you try to twist it. If you truly believe all this stuff works, then you are covered and I will die. Of course, it’s a safe bet that we all will. I will choose to die a free man without the government lording over my health decisions. It goes against everything that this country was founded on. That is the real issue here.

  19. Each time I look in the mirror, I do not see a guinea pig.
    That is reason enough for me to NOT subject myself to genetic treatment that is by definition STILL experimental, much less proven to be FAR more dangerous than any traditional vaccine (which, again, by definition it is not ).

  20. We have freedom of conscience. Plenty of credible information from other countries specifically itemized contents. This use of such tissues is prohibitive regardless of passage of time. “No weapon formed against you shall prosper”.

  21. The latest missive from the CDC is that “previously vaccinated individuals are more susceptible to infection from the latest Covid variant, than unvaccinated individuals.” You are a special kind of stupid if you take the new jab!

    • They were advertising it before it was even created. Maybe the new variant got delayed. Production issues in China. Forced labor can be problematic.

  22. Did the FDA approve the latest Pfizer vaccine under emergency use authorization? That is what I heard. The White House said that the plandemic ended in the spring – like May? If this is a the case, then the FDA used an unauthorized reason to approve the jabs – they would be considered unauthorized (in an honest world) because there is no emergency.

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