Pfizer plans to seek authorization for booster shot, FDA & CDC say no booster needed

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Pfizer Biontech announced yesterday that it would seek emergency use authorization for a booster shot to be administered six months after their second dose, when antibodies wane. The company wrote in a statement that initial data from a study they’re conducting shows that a booster shot, given six months after the second one, is well tolerated, effective at preventing specific variants and shows “neutralization titers… 5 to 10 times higher than after two primary doses.” That’s amazing news and is promising for those of us who are vaccinated and are worried about the variants. Only the CDC and FDA, in what was surely a response to Pfizer’s release, have stated that boosters aren’t currently necessary. Here’s more on this from CNN:

Drugmaker Pfizer said Thursday it is seeing waning immunity from its coronavirus vaccine and says it is picking up its efforts to develop a booster dose that will protect people from variants.

Pfizer said it would soon publish data about a third dose of vaccine and submit it to the US Food and Drug Administration, European Medicines Agency and other regulators. The company specified it would seek FDA emergency use authorization for a booster dose in August.

But in an unusual move, two top federal agencies said Americans don’t need boosters yet and said it was not up to companies alone to decide when they might be needed.

Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet. “Americans who have been fully vaccinated do not need a booster shot at this time,” they said.

In a statement to CNN on Friday, the World Health Organization said, “We don’t know whether booster vaccines will be needed to maintain protection against COVID-19 until additional data is collected,” adding, “limited data available on how long the protection from current doses lasts and whether an additional booster dose would be beneficial and for whom.”

Pfizer and its partner BioNTech said evidence was building that people’s immunity starts to wane after they have been vaccinated. The Pfizer vaccine requires two doses to provide full immunity.

“As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high,” Pfizer said in a statement emailed to CNN.

“Additionally, during this period the Delta variant is becoming the dominant variant in Israel as well as many other countries. These findings are consistent with an ongoing analysis from the Companies’ Phase 3 study,” it added.

“While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection.” It gave no further details.

[From CNN]

I’m truly sick of the clowns at the CDC and am following the advice and guidelines of the WHO. If the CDC and FDA wanted to issue a statement it could have been a more measured one, similar to the one from the WHO, saying that they’re still evaluating whether boosters are needed. Instead they dismissed Pfizer’s statement with this terse one. They seem to be catering to the lowest common denominator in the US and are focusing on cajoling people into getting vaccinated instead of following the science. If the efficacy of the shots wanes at six months people should be getting booster shots. We don’t know the long term effects of coronavirus and even mild case have resulted in long haul symptoms.

There are people who are not going to be convinced to get vaccinated no matter what and a lot of them are getting sick and dying. Unfortunately those covid deniers are also enabling the virus to mutate in a way that makes the shots less effective. If Pfizer says we should get another shot at six months I hope the FDA makes it possible for us to get one.

Below and on the front page is a photo of Sandra Lindsay, “a Queens nurse who was the first American to receive the Pfizer vaccine in December.” She was the grand marshal at NYC’s tickertape parade on Wednesday for COVID-19 workers.

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44 Responses to “Pfizer plans to seek authorization for booster shot, FDA & CDC say no booster needed”

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  1. Piratewench says:

    Ugh I’m exhausted. I have the Pfizer shot. I’ll take the booster when it’s available! It’s not that big of a deal. And I trust the company over the CDC at this point, which is a damn sad reflection on the CDC!

    • Lizzie says:

      Me too. If I can go to local pharmacy like CVS or Walgreens I’ll be there exactly at 6 months. Not a big deal and it doesn’t mean the vaccines don’t work. Clearly they do work as the recent covid deaths in the MO hotspot of Springfield have all been unvaccinated people.

  2. goofpuff says:

    Trump broke the CDC. It used to have such clout and now I think it’s a joke. CDC must have lost so many good people fleeing from the Trump clown show (happened at many federal agencies Trump messed with).

    Also we take shots for flu every year to handle its variants. This makes sense for Covid.

    • North of Boston says:

      Yeah, I hope at some point the Biden administration sets up a “return to work” program for qualified workers who want to return to federal agencies, where they
      can come back, work in needed positions and have any breaks in service waived so they regain seniority, pay grade status, service time/earnings towards pensions based on where they were at when Trump or his minions fired them or made continued employment untenable

      “sorry lady, don’t care if you’re the most respected, most credentialed expert in a field that’s critical to the nation’s future well-being, don’t care if you’ve worked in DC for years, and that your home, your spouse’s career and kids’ schools are here in DC, your Urban Planning Analyst job is now based in Lost Springs Wyoming… starting Monday; also your pay is being COLA’d to be 50% of what you previously earned”

      • goofpuff says:

        If they’re civil servants, they either retired or went to the private sector. And the private sector you make so much money more doing the same thing, it would be hard to convince them to come back especially with 2024 looming over them.

        US Civil Servants do not make as much as everyone thinks. It’s the benefits that call people in along with the attitude of service because you really have to believe in what you’re doing to be ok with being paid 40% less than your commercial counterparts.

      • BeanieBean says:

        I’m a fed & I can say if you quit quit, but come back, you’d still retain your time in grade, your # of years of service, leave status & so on. Any unused sick leave would still be there for you. If you were earning eight hours of annual leave a pay period, that would remain the same. If you left as a GS-12, you could return as a GS-12, because you’re qualified. And your pension is based on the time you actually worked, so time spent away during the trump years, unfortunately, would not count, but all those previous years would.

  3. Lauren says:

    If the company says that a booster shot might be needed I’m getting that booster shot and to hell with it. Covid will not be going away any time soon. Not while people behave like selfish aholes. I would prefer to help my immune system keep its defenses against it updated rather than risk getting seriously ill just because a third shot might no be needed.

    • SS says:

      What if we aren’t allowed to get the booster shot? Like someone has to write a prescription and they won’t based on the CDC recommendations?

  4. Oh_Hey says:

    What is the point of catering to those that don’t believe in the vaccine or in the seriousness of Covid? They aren’t coming back, even when folks have been “nice” and “understanding” in trying to convince them.

    Let them go. Give me my booster. Make vaxx passports/immuno compromised passports mandated to do anything and let us folks with sense live.

    • (TheOG) Jan90067 says:

      I am SO onboard for vax passports, with ones for those with med. expemptions, to be in a centralized data bank so we can show the digital code on our phones and just get on with life in a SAFE way.

      Seems that LONG GONE are the days where you cared about your community/your fellow man/woman. Where the need of the many outweigh the want of a few (thank you, Star Trek/Mr. Spock! lol). You don’t want to get vaxxed…fine… your right to not do so. But you do NOT have a right to get anyone sick. You do NOT have a right to go to a crowded concert, sports venue, movie theater. Those are “perks” of being part of a society. They are PRIVATE companies that (I WISH) would set the terms of entry.

      I wouldn’t care if non-vaxxed want to hold their own events. Let them get each other sick. Play stupid games win stupid prizes. Just don’t breathe near me!

      • Larisa says:

        Unfortunately, private businesses are probably more likely to cater to the unvaccinated crowd, because they are the ones that keep the business going. They were the ones who never left when the rest of us hunkered down, they were the first ones to come back as soon as they could, they are the ones who are not deterred by crowded indoor spaces…

      • fluffy_bunny says:

        We been frequenting our favorite restaurants every weekend via curbside (even a steakhouse that sells their steak raw so you can cook at home) the whole pandemic and tipping so all they are really losing out on are beverages. The only restaurant we dropped was a breakfast place across town where the food would have been cold by the time we got home. Everyone is considered fully vaccinated today and we live in a high rate of vaccination area so we may be ready to ease into going back out to places.

  5. Case says:

    The CDC and FDA better not make it difficult for us to get boosters. If the companies say we need them based on SCIENCE (and we’re fortunate to have a lot of data from Israel about vaccines), then I want the booster. I’ll pay for it. I’ll donate money so other people who can’t afford it can get it. Whatever. I’m so over the CDC’s BS and I can’t believe they’re still so problematic under the Biden administration.

    The fact that they’re likely saying no to this because they think more people will get the vaccine if it’s a one-and-done situation is wildly ill-advised.

    • Darla says:

      Ohhhh, I hadn’t thought of that. I thought maybe it was financial, like they don’t want to pay for more free shots. This makes more sense. Yeah, those people are a lost cause, and I’ll do the same as you.

    • North of Boston says:

      Whether or not it’s the driver, the financial side is going to become an issue if the CDC sticks with the “no boosters needed” stance if they ARE in fact needed, according to the current best science available.

      Because good luck getting health insurance companies to cover the cost of those vaccine boosters, or worse, getting payments from Medicare and Medicaid (which cover healthcare costs for many people on fixed incomes with no ability to fund extra expenses*) if the CDC insists boosters aren’t required or even recommended.

      *heck some of them, those with diabetes, wind up rationing their insulin … taking less than is needed… because of costs – insulin which is needed to control their condition keep them alive and/or prevent costly, disabling complications of uncontrolled diabetes – blindness, kidney failure, strokes, amputations, heart failure

    • fluffy_bunny says:

      I saw the receipt for my first dose and it said I saved $2.53 by having insurance so the vaccines are relatively low cost. I’d be fine if I had to pay for them like I used to have to pay for the flu shot. I think the most I ever paid was $25.

      • Rose says:

        Oh just wait until the manufacturer decided to hike the prices. That’s what happened with every medication under the sun.

  6. Fifee says:

    I’ll take the booster when It becomes available in France. My only concern is that I had a bad reaction to my second dose ( temp of just under 40C 4 nights running, in pain for over two weeks, took nearly a month to feel ‘normal’ again, had a test because I thought there was no way in hell this ‘illness’ was from the jag but I was negative) and im worried that I will react to the booster. Still I would rather that than ending up in hospital.

  7. astrid says:

    Thanks for showcasing Sandra Lindsay!

  8. Becks1 says:

    If the company says I need a booster, I’ll take the booster.

  9. (TheOG) Jan90067 says:

    As we’ve seen, the CDC AND the FDA have been, and are BEING used as political tools. They always were, but we weren’t made as aware of it until TFG “broke” it, as Goofpuff says. Initial reports out of Israel, who has most of its pop. fully vaxxed, says that the initial shot’s efficacy is waning against these stronger variants (Delta AND Delta PLUS). So yeah…GIVE ME THE BOOSTER. In tests so far, it’s said to up your protection against these quite high.

    Covid is NEVER going away. Like the flu, it will continue to mutate. And like the flu, we will need yearly shots with what is *hopefully* the best guess as to what will combat the strain(s) that will be floating around the coming flu/covid season. It’s just going to be part of life now. Hopefully, like the flu, we’ll be able to keep it “manageable” and not as deadly as it is now.

    SCIENCE is what we need to follow, NOT these political hacks.

  10. Lindy says:

    I wish the Trump administration hadn’t succeeded at totally gutting the CDC add undermining trust in it. It’s stressful to be in a place where we can’t fully buy something that the CDC is saying. Infuriatingly, it’s not like I really trust something announced by Pfizer when it clearly serves their bottom line.

    I got the Moderna in March, and then got a breakthrough Covid infection in June (confirmed by PCR test). Luckily my only symptoms were a fever for 3 days, what felt like a terrible sinus infection, and complete loss of taste and smell. I was pretty shocked and freaked out; my husband’s also fully vaxxed and my oldest turned 12 in June and got his first dose (second dose in a week).

    I’ll probably get a booster shot (maybe J&J just to have a different form of protection than the mRNA I have from Moderna).

    I mask indoors, still (willing to admit it’s partly anxiety on my part), WFH, and still do curbside grocery pickup. I’m not sure where I got it, but the rest of my household all had negative Covid tests (and we all had negative strep tests as well just to rule that out). I had to do my first in-person work event (mandated by my boss) since March 2020 so I have to think I picked it up in one of the event venues or restaurants.

    I think it wouldn’t be a surprise if we do all the up needing booster shots. I live in a blue city in a red state, so some while our city vaccination rate tops 60%, once you go ten minutes outside the city that drops to below 40.

  11. Kkat says:

    I had active covid for 4 months, where I was fully symptomatic.
    It took another 3 months for the exhaustion, headache and breathing to get back to mostly normal.
    I think I’ve had some relapses before I got vaxxed that would last a week or two, exhaustion and headache.

    I got my second Pfizer shot may 3rd, I had an immune response to the first that lasted about 5 days. The second the civid exhaustion hit me so bad I couldn’t get out of bed for 2 weeks. Going to the bathroom would make me shake and I’d have to lay there for an hour after too weak to move.

    So you can definitely get a pretty strong reaction

    But what is still worse is getting covid, and I only had a moderate case (and long haul)

    I will be getting the booster and if it doesn’t get approved I will consider getting another Pfizer shot to boost my antibodies when the time comes
    I’m thinking the booster will be approved, because the delta variant is no joke
    And if we get delta plus spreading…. That won’t be good…

    • Robin says:

      I’m really sorry to hear what you’ve been through. I got covid at the very beginning. I have only had it diagnosed in retrospect so can’t be 100 per cent sure. I coughed every day and night for three and a half months. It was hell. But not as bad as you sound. Had both pfizers. It’s no joke, this illness, and I was shattered. It took me weeks to be able to breathe open fresh air without coughing.

  12. Maxime duCamp says:

    My fear is that without a booster, for a lot of us (at least in the US), who were fully vaxxed by late spring/early summer, the waning immunity will hit right around Thanksgiving making the 2021 holiday season another minefield. Most of us who took COVID-19 seriously faced a lonely holiday season and I’ll do it again if I have too but my sister will be none too pleased if she doesn’t get to see me at Christmas this year. So yes, by all means, bring on the booster shot, ideally before folks start traveling to see family for the fall/winter holidays.

  13. LaraW” says:

    Guys, I don’t think the statement from the CDC and FDA are as unreasonable as CNN is making out. The CDC FDA statement in full:

    Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.

    – A few points: they are saying it’s not needed AT THIS TIME. They aren’t saying it’s not necessary AT ALL.

    Also, they make a good point that they are going to evaluate it based on, “laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.” In other words, they aren’t going to rush to approve the booster simply on Pfizer’s word. They’re in the middle of reviewing and evaluating the data.

    And, from what I can see, Pfizer was the one who made the announcement, and Pfizer was the one who’s made claims about the efficacy of this third shot. Most of the medical community agrees that boosters will be necessary. However, now that the initial rush for a vaccine has slowed down, the CDC, FDA, and NIH can take time to evaluate Pfizer’s claim that this specific 6-month booster is absolutely necessary. And while this six month booster coincides somewhat with the rise of the delta variant, it also coincides with the 5 month anniversary of the vaccine roll-out, where the US government footed the bill for millions of vaccines to be provided at no cost. I don’t think it’s unreasonable for the government to say they’re going to do a thorough review of the literature, now that almost 70% of people in the US have gotten the first shot.

    • DiegoInSF says:

      I agree with you, I am fully vaxxed by Pfizer but wouldn’t this be super beneficial financially for them? One study and now we need booster shots, sounds like the CDC wants to wait for more info. Wasn’t there ANOTHER study recently that said Pfizer and Moderna provide lasting protection? I just can’t keep up.

      • Cava24 says:

        They do have a financial incentive to push for a third round but the approvals take awhile so if they really want to be ready by the time the data about the necessity of the booster is in, it makes sense to start now.

    • april says:

      I think it’s good they are playing it safe and analyzing everything before they decide if you need a booster. I, like most of you, would get the booster in a heartbeat but we have the radical right that will bash the booster and try to destroy the reputation of vaccines if anything goes wrong.

  14. Katherine says:

    I don’t care what the official recommendation is as long as it’s allowed to get the third shot or however many is best. Even if they don’t think it’s needed, I think people should be allowed to make this choice for themselves. I’ve heard people who got the one shot vaccine can’t get an mRNA one which is absolutely wrong – if someone wants to get a booster shot, they should be allowed to, given there isn’t dose shortage.

  15. Kkat says:

    Everyone in my house is vaxxed, my husband my two sons 16 and 25
    My sister and my brother in law and my 15 year old niece live here, all fully vaxxed with Pfizer.

    I have two more sisters, one is a malignant narcissist maga pos that I have grey rock. Her family isn’t vaxxed because Murcia

    My other sister won’t get the vaccination because “its too new”
    My mom and dad are Facebook fox news maga morons
    My dads heart Dr told him the if he gets covid he will 100% die
    My mom told me she read (a meme!!!!) On Facebook that the vaccination is killing lots of people so she doesn’t want to risk it….
    I’ve given up trying to reason with her or my sister.

    So it will be horrible but in my head I’m preparing myself for my stupid family members to die.

    I’m in long beach California

  16. Haylie says:

    I’d trust Phizer over the CDC. The CDC claimed masks were unnecessary, then Delta and Lamda variants emerged and are sending unvaccinated people to the hospital, but they won’t admit they were wrong about mask mandates because of the political blowback.

  17. Sunday says:

    Once again the CDC (with an assist from the FDA this time) are doubling down on the absolute worst communication strategies. This is “YOU DON’T NEED A MASK TO PROTECT YOU” levels of idiocy, because we all know full well that we are going to need a booster shot at some point (just like the flu shot). So WHEN we reach that time, the magats have their bs talking point ready to go, because ‘tHe CdC sAiD wE dIdNt NeEd BoOsTeR sHoTs.’ It’s absolutely maddening.

    They don’t want to recommend a booster because they know that fully vaccinated people would immediately flood every vax site, taking up appointments and shots that they’d rather give to unvaccinated people (not to mention budgeting for ordering additional vax supply). It’s the same as the UK stretching the time in between doses so more people get their first shot. The problem is, the unvaxxed in this scenario are NEVER going to listen to Fauci, the CDC, or anything this administration says. It’s insane that these officials don’t recognize that.

    The CDC statement is also *very* carefully worded – notice how it never says anywhere that the current vaccine protocol prevents infection. It doesn’t. And while I’m thrilled that having 2 shots from Pfizer means I likely (knock wood) won’t die or be hospitalized, I also don’t want to risk getting Covid and dealing with the potential long-term impacts or side effects that science doesn’t fully understand yet.

  18. YAS says:

    I think what the CDC is saying is that right now they don’t think people need boosters, but they will review data as it becomes available. We should act with *some* skepticism towards Pfizer’s claims because they are after all a for-profit enterprise and have a profit incentive. If scientists review the data and agree with the claims about a third booster being required and when, I’m sure the CDC and FDA will respond accordingly. The question is how long will it take them to review the data because if 6 months is indeed when immunity starts to wane, a lot of healthcare workers got vaccinated in January and Feb and March and would need boosters available much sooner because 1) their time horizon is earlier than a majority of the population and 2) by the nature of their jobs, they are more likely to come in contact with the virus in their day to day life.

    I do agree that the CDC is playing a dangerous game re: masking though. We’re nowhere near where we need to be vaccination-wise to permit people to go maskless. Letting a virus run amok among a partially vaccinated population is a recipe for disaster.

  19. Jayna says:

    Pfizer was my vaccine, and I will be getting the booster shot. And it’s not just Trumpsters who aren’t getting vaccinated. I need to protect myself from the variants in Florida.

  20. Jayna says:

    @Linday, regarding your post up higher about doing a non-mRNA vaccine as your booster (Johnson), this vaccine looks right up your alley and those that don’t want a mRNA vaccine. Hopefully, Novavax will be out later this year. I’m sticking with Pfizer, though, for my booster. I don’t even know, though, if I could do Novavax as a booster. This is also a very interesting article on Novavax. I have a liberal friend who refuses to do a mRNA vaccine. She is still wearing masks, etc. Then the Johnson vaccine was a no-go because of its bad press. But this one when it comes out she will do.

    “The latest Novavax data confirm that it’s possible to achieve the same efficacy against COVID-19 with a more familiar technology that more people may be inclined to trust. (The mRNA vaccines delivered efficacy rates of 95 and 94 percent against the original coronavirus strain in Phase 3 trials, as compared with 96 percent for Novavax in its first trial, and now 90 percent against a mixture of variants.”

  21. Moxylady says:

    But I want it!!!!