Is the FDA-approved Covid vaccine the one they're giving people?
November 7, 2021 1:09 PM   Subscribe

I know, yes. Yes, it is. But, like a lot of people, we have a family friend who has been watching too much Fox News, and is holding off getting vaccinated because, among other things, she claims the government pulled some kind of bait and switch, and the vaccines the FDA approved are not the ones being administered to patients.

This makes no sense to me, but it apparently does to her. I recall seeing something mentioning this as an anti-vax talking point and debunking it, but I can't seem to dig it up.

Can someone point to something that specifically talks about this? I've found sources debunking other common claims (it makes you contagious, there are microchips in it, etc.) but not this one.

Extra credit: she also says 8,000 deaths have been caused by the vaccine. Is there an actual, verified (non-zero) number of deaths attributed to the vaccines?
posted by Naberius to Science & Nature (11 answers total) 1 user marked this as a favorite
 
Best answer: I'm not sure why you're looking for sources if your family friend is not offering you any, but...

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html

Reports of death after COVID-19 vaccination are rare. More than 423 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through November 1, 2021. During this time, VAERS received 9,367 reports of death (0.0022%) among people who received a COVID-19 vaccine. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths pdf icon[1.4 MB, 33 pages].
posted by miasma at 1:15 PM on November 7, 2021


I came in to mention vaers too. Clicking through to the PDF, there have 5 plausibly attributable deaths (out of close to 200 million vaccinated people).

Frankly though if someone is so deep into conspiracy land that they believe the govt is secretly giving out unapproved vaccine instead of the approved safe and effective vaccine, they aren't going to believe any govt source like the cdc or vaers.

You could ask your friend what source they might trust. Their response will be instructive.
posted by basalganglia at 1:22 PM on November 7, 2021 [4 favorites]


Best answer: the vaccines the FDA approved are not the ones being administered to patients

This is, as any sane person would expect of anything broadcast from the Murdoch Death Star, complete bullshit. Comirnaty is the Pfizer COVID-19 vax, not some alternative "version" of it.

she also says 8,000 deaths have been caused by the vaccine

This is a standard anti-vaxxer talking point, and it's always based on selectively misinterpreting stats about deaths following vaccination as being about deaths definitely caused by vaccination. Usually by the same folks who dispute the official COVID death stats as deaths "with" COVID; these people love to have it both ways.
posted by flabdablet at 1:35 PM on November 7, 2021 [14 favorites]


What I've heard is that is a very incorrect interpretation of the approval letters means that the vaccines with the brand names of the vaccines are approved, Spikevax (Moderna) and Comirnaty (Pfizer), but the ones under the Emergency Approval have never used those names and have different labeling, therefore their contents are different.

The fact that all the new official documentation had to suddenly change to use the new Spikevax/Comirnaty brand names provides some evidence for this wrong conclusion.
posted by meowzilla at 1:36 PM on November 7, 2021


provides some evidence for this wrong conclusion

if you stick your fingers in your ears and shout "la la la I can't hear you", sure.

The emergency approval for Pfizer's vaccine happened before they named it "Comirnaty"; the subsequent full approval happened after. This is difficult to understand only to folks who are already fully committed to making it difficult.
posted by flabdablet at 1:43 PM on November 7, 2021 [6 favorites]


If this is someone you care about, instead of debunking stuff that has no source in the first place, cult experts suggest responding to the fear that drives the urge to believe that there is some mass undertaking to kill perfectly good consumers/cheap labor, if you think it is actually fear and not narcissism or a need to feel "special" by holding insider knowledge, or outright glee at the idea of mass deaths.

Your family friend is teetering on the edge of the qanon abyss, and there is probably a short window of time here to catch them before they fall, but I don't think facts are the lifeline most save-able people are going to cling to. I think you're more likely to get traction with an approach more like hey, I get these are really scary times, is that why you're so worried someone's trying to hurt you despite boring data that suggests otherwise? How can I help you feel better?
posted by Lyn Never at 1:55 PM on November 7, 2021 [7 favorites]


Best answer: This is not a good objection, but there is a language difference that allows people acting in bad faith to inject doubt and uncertainty.

The Pfizer-BioNTech mRNA had EUA or emergency-use authorization but had been given full approval in August 2021. Both the EUA and approved vaccines have the same formulation. The Moderna mRNA and Janssen ("J&J") adenovirus vaccines still have EUAs. Further, there was FDA authorization recently given to administer different vaccine types as booster shots.

The EUAs are authorizations: not the same as approval, legally speaking. The EUA sets up a streamlined approval process and makes drugs accessible based on best available evidence for a specific purpose. These vaccines go through the same three-phase clinical trials as any other drug before being granted an EUA. This authorization can be revoked at any time, based on new evidence.

By way of comparison, the Regeneron monoclonal antibody therapy touted as a (very expensive) alternative to vaccination still does not have "full" approval, only the EUA. Ivermectin and other quack medications have no approval or authorization at all for prevention or treatment of this disease.

When antivaxxers talk about vaccine approval status and leave out these facts about the alternatives they propose, it underlines again that their objections on this basis were and are not made in good faith.

I doubt you are going to convince the brainwashed with these facts, but I do wish you luck. At the very least, you might trigger doubts in anyone listening to her, by bringing up the Regeneron EUA.
posted by They sucked his brains out! at 2:20 PM on November 7, 2021 [2 favorites]


Best answer: I spent a very cranky afternoon looking into this for my cousin. She asked specifically about this footnote on the FDA fact sheet for Comirnaty, and how a drug could be both approved and not approved and have different names:
"The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."

So, here's what I sent her. Godspeed.

Regulatory authorization/approval includes the product itself (what is in the vials) as well as how and where it's made, who will receive it and why, and what information will accompany the product. Changes after authorization/approval require further regulatory review. (See page 3 of the approval letter from August 2021 for the legal language.) Note, this is why there are so many "Letter granting EUA amendment" documents on the FDA Comirnaty & Pfizer page, to include further groups of eligible patients, and boosters/third doses. The footnotes on pages 2 and 3 of this EUA reissue letter from October 2021 are a readable summary of the authorizations/approvals.

FactCheck.org has an informative article on this exact claim. Among other things, it handily explains the footnote ("Vaccine Under EUA & Full Approval Use Same Formula" section):
Pfizer’s representative told us the “legally distinct” reference relates to differences in manufacturing — for example, the licensed product may be made at different sites or use materials from different approved suppliers.

Note, Comirnaty and the EUA Pfizer vaccine are not biosimilars. They are the same thing. A biosimilar is a new biologic that is different from an approved biologic in minute ways that do not impact its function in the body. (Adding this because I saw more than one article trying to say these vaccines must be different because there are no biosimilars for either.)
posted by esoterrica at 2:58 PM on November 7, 2021 [6 favorites]


Mention too that just because full approval has come through for the Pfizer vaccine, that doesn't mean the Moderna and J&J vaccines are no longer being administered because, of course, their status is totally independent. I can imagine the fact J&J is going to remain the vaccine of choice for targeting hard-to-reach populations somehow feeding into this conspiracy.
posted by hoyland at 3:45 PM on November 7, 2021


There have been studies of death from all causes after vaccination. Naturally, there are many fewer deaths from Covid-19 as expected, but also there are fewer deaths from all other causes, i.e. heart attack, etc. This seems unexpected, but it's also true for the traditional flu vaccine.
posted by SemiSalt at 6:00 PM on November 7, 2021 [1 favorite]


The thing that helped me really grok adverse events was the reported affects for both the placebo and non-placebo groups for the children's vaccine: including multiple fractures and a swallowed penny.
posted by freethefeet at 2:50 AM on November 8, 2021


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