Pfizer COVID-19 vaccine receives full approval from FDA

The United States gave full approval to Pfizer’s COVID-19 vaccine on Monday, a milestone that might help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet.

The vaccine made by Pfizer and its partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. More than 200 million Pfizer doses already have been administered in the U.S.—and hundreds of millions more worldwide—since emergency use began in December.

“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. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said in a statement he hoped the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”

U.S. vaccinations bottomed out in July. As delta fills hospital beds, shots are on the rise again — with a million a day given Thursday, Friday and Saturday. Just over half of the U.S. population is fully vaccinated with one of the country’s three options, from Pfizer, Moderna or Johnson & Johnson.

The FDA’s action also may spur more vaccine mandates by companies, universities and local governments. This month New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they’ve been vaccinated or else submit to regular testing and other requirements.

Anxious Americans increasingly are on board: Close to 6 in 10 favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events, according to a recent poll by The Associated Press-NORC Center for Public Affairs Research.

“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”

The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months—the time period when serious side effects typically arise.

That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot still has emergency authorization for 12- to 15-year-olds.

Even after hundreds of millions of shots, serious side effects—such as chest pain and heart inflammation in teens and young adults—remain exceedingly rare, the FDA said.

As for effectiveness, six-month tracking of Pfizer’s original study showed the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

Those data came before the extra-contagious delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.

As for all the talk about booster doses, the FDA’s licensure doesn’t cover those. The agency will decide that separately.

The FDA already is allowing emergency use of a third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients who don’t respond as strongly to the usual two shots. For everyone else who got those vaccinations, the Biden administration is planning ahead for booster starting in the fall—if the FDA and CDC agree.

Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying youngsters, with data expected in the fall.

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34 thoughts on “Pfizer COVID-19 vaccine receives full approval from FDA

    1. Ironically, Trump himself urged people at his Alabama rally to get vaccinated and they booed him for it.

    2. “According to two of the sources who have spoken to Trump about this, he has occasionally referenced polling and other indicators—such as what he’s seen on TV—that show how the vaccines are unpopular with many of his supporters. This has left the impression with some of those close to Trump that he doesn’t want to push too hard on the subject, so as to not “piss off his base,” one of the two people said.”

      Leadership is really hard when you have to tell people what they need to hear, not what they want to hear.

    3. It’s good to see Doc Brown and Marty McFly’s Flux Capicitor was able to perform the 5 and 10 year trials for side effects and long term efficacious.
      The FDA’s press release states that trials monitored recipients for 4 and 6 months. Not sure about you I have had cold last that long.
      The FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty (Pfizer trade name). 

    1. Get with what program? Your program? Since when did it become your job, or others, to expect anyone else to follow your own personal and confidential medical decisions?

    2. If there were anthrax or typhoid in the drinking water, would it be responsible to tell people that no health department or school, could tell people to boil the water before it was consumed? If this sounds pretty stupid it’s because it is.

      Wear a mask and get a vaccine. Don’t kill me or my family by infecting me, or worse yet blocking my access to health care because you choose to not get vaccinated are clogging the hospitals with COVID patients.

  1. Most scientists, virologists, epidemiologists, not affiliated with the government or anything to financially or politically gain from the weaponized C19 bioweapon show medical and scientific data that says otherwise and always censored by the government and their Big Tech accomplices.

    “Misinformation” as Big Tech calls it means we better listen up as to protect ourselves.

    All we hear and see from the affiliated is words and political propaganda with no supporting science and data.

    Why aren’t the affiliated using science and data supporting their claims?

    With all of Fauci’s lies and flip flopping and perjurying himself before Congress, the CDC’s constant discrepancies in statistics, and a government in place that has proven criminal and dishonest with everything else, who would trust anything with them? Especially one’s body and health.

    Why is Bill Gates a non elected entity or medical expert known for being in the vaccine business with disastrous results in his 3rd world countries experiments being allowed to lead or make public policy in this debacle. Do the research on him and you will find his Globalist affiliations with the idealogies of mass depopulation they’ve been conspiring for years to cast upon us.

    Now with the “vaccines” that aren’t really vaccines, we’re seeing injuries and deaths mounting into the thousands from taking the vaccines. Who wants to take the gamble on their life to be vaccinated for something that has over a 97% survival rate?

    Treatment would be the better option like is done with the flu and other epidemics of various strains.

    Why is this being managed differently or backwards to any other epidemics where you quarantine the sick and not the healthy?

    Why has the FDA forsaken their age old standards of 25 incidents of injury or death of a drug they pull it off the market???

    This corrupt government compromised with Socialist Marxist Communist Globalist Democrats and RINO GOP Establishment enemies of our Constitutional Republic are no one to trust just by the proven origins of how the CCP Virus came about bought and paid for by Fauci to the Wuhan Lab should tell anyone it’s a bioweapon and for that anything dealing with it is a political agenda and not a medical agenda in our best interests.

    Now more reports are coming out that the vaccinated are testing positive more than the unvaccinated as for the “vaccines” are causing them to shed off the virus thus making them several times contagious than most. They are now dubbed the “Superspreaders” Also the vaccinated are proving more vulnerable to physical sicknesses from the virus.

    With the proven complications of these experimental drugs as they mutate and morph in the body putting many in the hospitals injured or dying from just what they were injected with and nothing else, the question from the non government real science community are by what they are seeing; Will the vaccinated be alive in 2 to 3 years???

    1. The above is a compelling case for suing Fox News and Facebook out of existence for their role in perpetuating the pandemic by allowing nonsense to spread like wildfire.

      And it’s also why the Republican Party must choose either to purge the cranks and nuts from their party … and recommit themselves to American democracy. Or, they continue down their current path and become the reason that democracy around the world wanes. It’s their choice.

    2. Darrell W.,
      I was reading through your comments and was worried that you hadn’t used your catchphrase, but there it was – “Socialist Marxist Communist Globalist Democrats”. I was starting to get concerned that you had gone soft on us.

    3. @Darrell: — Now with the “vaccines” that aren’t really vaccines, we’re seeing injuries and deaths mounting into the thousands from taking the vaccines. —
      Source, Darrell, source? Neither fiat nor ukase will get you any points here.

    4. Joe, I agree. Let’s “purge the cranks and nuts”. As a member of the Progressive! Party, pleases show us the way. Will you start with Biden and Pelosi, or go to the bottom, purge AOC and Omar, and work your way up? Show us the blueprint.

    5. Chuck, that you think there’s any equivalence there tells me you are part of the problem, not the solution.

      MTG, Gaetz, Boebert, Gohmert …. this is the future of the Republican Party. It’s destructive to the American experiment.

  2. If you’re so cowardly or gullible that you’re afraid of this shot, proven safe-and-effective, and that hundreds of millions have taken with no issues whatever… You may wish to go ahead and move off the grid and live in a cave where you’ll have control of your life. Things aren’t going to get better for you in the coming years.

    1. Protonix, Prempro, Chantix, Depo-Testosterone, Effexor, Eliquis, Lipitor, Trovan…all FDA approved, etc.

      I don’t think it’s unreasonable for healthy and young (under 65) people to wait for long term data.

      With most likely over 80% who have either been infected with COVID or vaccinated by now, and a survivorship rate of 97%+, it seems some people just don’t want to be test subjects as herd immunity clearly won’t occur.

      But, where appropriate, insert the “my body, my choice” phrase…

    2. Make sure you also see how many people in the hospitals and ICU’s and on ventilators are unvaccinated as you wait for that long-term data to come in.

      If there’s anything to be angry at the CDC about, it’s the idea that people should wait 8 months for boosters. The data out of Israel seems pretty clear boosters are needed 4-6 months out … we are going to lose a lot of HCP’s for several weeks and we will just have to let the J C B’s of the world die in tents due to understaffed hospitals. Their body, their choice…

    3. Joe B.

      Like I’ve stated before, please start mandating smoking cessation, elimination of fast food, drugs, alcohol, along with the every 4 month booster shot demand, etc.

      I bet many of the hospitalizations will continue to be the 78% who are noted to be obese/overweight, and my suspicion is mostly vaccinated patients to boot.

      We noticed that back in April/May of 2020 locally that anyone under the age of 65 in the ICU were obese or had other major comorbidities.

      Just playing the odds for those “die in tents” patients, eh?

    4. So based on what you’re saying, most people in Indiana should get the vaccines since Indiana “continues to struggle with some of the highest rates of obesity, smoking, physical inactivity, annual immunizations and public health funding in the nation.”

      Which do you want it to be?

      Enjoy your upcoming mandated vaccination at work or finding a new field to work in. Your body, your choice, right?

    5. “It is becoming clear that this is a very dangerous, way more dangerous virus than the original one,” Dr. Ricardo Franco, MD, an Infectious Disease Society of American (IDSA) member and assistant professor of medicine at the University of Alabama at Birmingham (UAB) said, in a briefing held Tuesday. “

      “Franco, who noted that about 97% of hospitalized patients at UAB are unvaccinated, said the delta variant pushes the threshold needed for herd immunity higher due to increased transmissibility. “

      “He also noted that despite the virus acting more dangerously than previous strains, the majority of cases, hospitalizations and deaths involve unvaccinated people in areas of both high and low vaccination rates, meaning the vaccine is working.“

      “Data shows that a vaccinated person is eight times less likely to get infected by delta compared to an unvaccinated person,” he said. “[A vaccinated person] is 25 times less likely to be hospitalized, and if hospitalized, 25 times less likely to die from COVID-19.”

    6. Pretty sad the Cleveland Clinic has to walk back data because they don’t like the perception of the the outcome.


      Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.

      Even needed a press release.

      Keep moving the goal posts…because science. All while the VAERS data keeps climbing.

    7. Yeah, science. Right across the top of said article it says the following:

      “This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.”

      You also refuse to acknowledge VAERS ain’t telling you what you think it is.

      The odds that you’re actually smarter than infectious disease experts who’ve studied this stuff their entire lives … are much lower than the odds that you’ve fallen prey to the nonsense spouted by right-wing media. You can’t trust the experts, everyone’s out to get you, and you’ll be smarter than everyone else … if you just read what we tell you to read and misinterpret it the way we tell you to. Look, you’re self taught!

      Infectious disease ain’t changing the oil on your car. You’re not going to self-teach your way to a position of knowledge. It flat won’t happen. Give it up.

    1. The people suing Facebook because they read some garbage about taking anti-parasite medicine and believed that … instead of actual medical advice?

      Especially when they find out Facebook knew the information was nonsense and they let them see it anyway to make money off it.

  3. It’s good to see Doc Brown and Marty McFly’s Flux Capicitor was able to perform the 5 and 10 year trials for side effects and long term efficacious.
    The FDA’s press release states that trials monitored recipients for 4 and 6 months. Not sure about you I have had cold last that long.
    The FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty (Pfizer trade name). 

    1. Steve – the shot had also been given to many more people than the usual drug studies. Which doesn’t fix the space time continuum issue you mention, but is advantageous in different ways.

      At the end of the day, if the choices are getting people vaccinated, or just dying our way through it like J C B is advocating with hospitals everywhere on diversion, I’ll try my luck with the shot, thanks.


      Hey J C B … attack? It’s called debate. If you don’t like it, don’t post misinformation. Guess I draw some inspiration from the below:

      Abdul-Hakim Shabazz: When people start talking crazy, call them out

      Fox News tells people to get the shot and they still won’t listen. Maybe they’ve realized dead viewers are useless to them.

    2. What is very apparent over the last 16 months is either accept one narrative or an arbitrary set of “facts” or be labeled something by Joe , et. al. No matter how many times the logic is twisted or the goal posts move.

      Mask on, mask off. Vaccine works, no mask. Wait, vaccine but still mask. Now booster shot. Now European doctor (because an expert they say) promotes COVID-22 and super-variant.

      Significant lack of data and transparency, but everyone should just trust the politicians and CDC. Well, Tony Fauci and the rest of the team have lost all credibility. No one wants to talk about accountability for this pandemic and virus, just smoke and mirrors and political stunts.

      People say “trust science”, or “the epidemiologists are the professionals,” etc. Well they are getting a failing grade so far…and by a long shot. Even 60 minutes ran a story last week exposing the CDC is a joke. CBS program if you notice…

      If someone debates this, they are labeled as Fox News watchers or Trumpers or whatever woke buzzword there is at the moment.

      Sorry Joe, et. al., I don’t fall into those categories, and many people don’t either…but they do look critically at things like healthcare and personal health.

      And the plan of comply or you’ll die isn’t so black and white. Can I say colors anymore?

    3. Tell me, does your hospital still use leeches and bleeding to treat patients? I mean, that was state of the art years ago. Why’d we move on from that?

      You work in healthcare, you claim. You of all people should know that science and medicine doesn’t offer certainty. They, like all of us, learn as they go. Hell, the actual medical professionals have learned tons how to treat COVID patients over the last 16 months to get better outcomes than they did at the start of the pandemic. Do you go scream at them at how they’re clowns for not getting it right in February/March 2020?

      I’m still waiting on the news stories about how COVID isn’t that bad from the ER docs and ICU staffers. The big expose that shows this is all a scam. With all the hospitals in America, and all the starving journalists out there who’d be set for life with such a big story… really odd they can’t seem to find one.

      Instead, I’m supposed to trust people who think that, no, the scientists have it all wrong. I’m just as smart as they are, they just can’t handle the debate! Take animal dewormers to treat/prevent a human respiratory illness, they tell us.