FDA approves boosters for immune compromised people, CDC needs to sign off

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Last month, Pfizer announced that they planned to seek emergency FDA approval for a booster shot of their vaccine, given six months after the last series of their shots. Their studies showed that the third shot was well tolerated and that it provided “neutralization titers… 5 to 10 times higher than after two primary doses.” Many of us welcomed this news because people are getting breakthrough covid cases from the more powerful variants. However the CDC and FDA issued a terse statement responding to Pfizer’s press release in July, stating that “Americans who have been fully vaccinated do not need a booster shot at this time.” The FDA is now recommending that immunocompromised people, including organ transplant recipients and those with cancer and HIV, get booster shots from booth Pfizer and Moderna. We’re still waiting to hear what the CDC says about this because they have the final word.

The Food and Drug Administration authorized Covid-19 vaccine booster shots for people with weakened immune systems, a highly anticipated move intended to shield some of the most vulnerable Americans from the highly contagious delta variant.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The agency said organ transplant recipients and people who are similarly immunocompromised can receive a third dose of the Pfizer-BioNTech or Moderna vaccines. The FDA also emphasized that other fully vaccinated people are “adequately protected” and currently do not need an extra dose.

The FDA OK is not the final go-ahead. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Friday to consider shots for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third shots could begin immediately.

White House chief medical advisor Dr. Anthony Fauci said last week that federal health officials were speeding regulatory efforts to clear third doses for such people, including cancer and HIV patients or those who have had organ transplants. He said new data suggested they don’t produce an adequate immune response after receiving two doses of a Covid vaccine.

“Immunocompromised individuals are vulnerable,” Fauci said Thursday. “It is extremely important for us to move to get those individuals their boosters, and we are now working on that, and we will make that be implemented as quickly as possible. … It is a very high priority.”

Such people represent only about 2.7% of the U.S. adult population but make up about 44% of hospitalized Covid breakthrough cases, which is when a fully vaccinated individual becomes infected, according to recent data from a Centers for Disease Control and Prevention advisory group.

[From CNBC]

I would like to see booster shots made available to older people and the general public on a tiered system similar to how the vaccines were originally rolled out. However we have such a surplus in the US that it’s easy for anyone to go to a drug store or community event and get a third vaccination. There’s no central system to check and many people have already gotten boosters. It’s estimated that over 1.1 million Americans have already had a third unauthorized shot. Of course this is unfair to other countries who don’t have access yet. The WHO has called for a moratorium on boosters until the end of September so more countries can get vaccinated, but that’s the situation we’re in.

I’m happy that people who most vulnerable will hopefully be getting booster shots. I truly hope the CDC does the right thing and quickly approves this. I’m still upset that they lifted mask recommendations. That was ridiculous, premature and had deadly consequences. They were catering to the antivaxxers and trying to persuade people to get vaccinated. That didn’t work, but the fact that so many more people are dying and getting seriously ill did. As cases spike and intensive care units are filling up through the US, more than 500,000 people a day are getting vaccinated in the US. I just hope that vaccines are approved for children under 12 soon and that the rest of us can get boosters without sneaking around.

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10 Responses to “FDA approves boosters for immune compromised people, CDC needs to sign off”

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  1. Charlie says:

    As of now the guidelines will require a letter with standardized language from your physician, so doctors are being quietly informed.

    • Mac says:

      I heard a report this morning that the data coming out of Israel shows the vaccines are 50% effective against the delta variant. That’s a lot lower than the 95% effective against the original virus. We’ll be getting many more shots before this over.

  2. Oh_Hey says:

    I don’t get all this hemming and hawing around the anti mask and vaxx crowd. It’s abundantly clear that we never should have stopped masking (I didn’t) and based on all the breakthrough cases (including by fully vaxxed bestie and her husband) we should seriously be getting on boosters.

    We take flu boosters every year because the corona that give you the flu mutates. How is this any different? The responsible thing to do is to stop catering to the fools, give boosters, and start shipping doses to countries that want and need it.

    • Case says:

      Agreed completely. I don’t understand why the CDC is catering so much to the crazies. They’re not going to change their mind for anything at this point, so it’s the CDC’s duty to help protect those of us who are doing our part.

      I want a booster. I’ll gladly wait in line behind people who need it more than me, but I want it regardless!

      That said, it’s shocking to me that that many people have gotten an unauthorized third shot? I don’t think that’s a good idea, or how boosters work?

      • Charlie says:

        The CDC is concerned with lack of long-term studies. The COVID-19 vaccine made by Pfizer and BioNTech appears to put young men at elevated risk of developing a heart muscle inflammation called myocarditis, researchers in Israel say. Talk to your doctor and then…

        Consider that we are not taking vaccines from those who need and wanted them, but rather those who have rejected it. If you are 6 months out and want a booster know that those under Trump did so little that there is no single database in the States. You may be in the files at one chain drugstore, but won’t be in others.

        If you need it, I hope this info helps. And thank you for reminding people that “there is a catastrophic amount of vaccine misinformation among younger people”. We have to be louder than the liars.

      • Oh_Hey says:

        so the unauthorized booster seems ill-advised. I’ll get happily get a sanctioned one but only after they get the dosing recommendations and stuff solid. My push is that they (the CDC or FDA) get on figuring that out ASAP not that we take up DYI health care

  3. LadyMTL says:

    While I agree with allowing boosters for those who are immune compromised and / or have health issues that would make it necessary, I don’t think it’s right to be offering it to the general population while so many other countries are struggling to get their hands on vaccines.

    If we really want this pandemic to calm down and go away (fingers crossed) people all over the world need to get vaccinated, not just here in North America. I understand the urge that some would have to get a booster – thanks, variants – but let’s let the rest of the world have their first and second doses as well.

  4. CL says:

    My mom has had two organ transplants (yay for genetics!), and participated in a John’s Hopkins study earlier this year to see if transplant recipients built antibodies like everyone else did. It was discovered that they didn’t, so she got a doctor’s note and got a third shot.

    On a completely different note, my son starts college next week. His college is not mandating covid vaccinations or masking, and there will be a LOT of unvaccinated students. There are already parents threatening to sue the university if there are mandates made. When I went to said university in the 90’s, there was a measles or chicken pox outbreak. At the time, the school told unvaccinated students and employees that the had to get the vaccine to stay at the school/get paid. Everyone got the vaccine without complaint. It’s mind boggling how far backwards we’ve gone.

  5. Kdiggity says:

    I’ve been trying to find an answer for this everywhere, but to no avail. My partner has kidney failure and has been on dialysis for over a year. He’s a cancer survivor from 20 years ago, too, and got the J&J from the dialysis center. These boosters are from Moderna ans Pfeizer, so even if they are approved, can someone who got J&J also take them? I’m surprised and frustrated that none of these medical or news articles bring this up, as if everyone just got the 2 shot vaccines.

    • Remy says:

      I think he can. In San Francisco they are giving supplemental shots (they’re calling it supplemental instead of booster) of the mRNA vaccines to people who got JJ.