On the one hand, I keep getting hammered with messages about how very safe the vaccines are. But then when I read the fine print, it turns out that they’ve been approved for emergency use only.
I feel like I’m missing part of the story. Why haven’t the vaccines been approved for NON-emergency use? If the only problem is that a total approval requires more testing, and there simply hasn’t been enough time to do that testing, doesn’t that indicate that the vaccine might not be quite as safe as the hype claims? I could go on and on, but I hope my question is clear.
(FWIW, I got my second dose well over 2 months ago. And I was aware that the approval was for emergency use only, so I am not complaining that anyone fooled me. But back then, when demand was high and the vaccines were rationed, no one sugar-coated the “emergency use” caveat. My problem is that now, when “they” are getting desperate for more people to get vaccinated, it feels like there’s a cover-up going on.)
Because the vaccines are new (relative to other medical treatments). Full approval involves a six-month efficacy study as part of Phase 3 out of 3, so that is the holdup.
That being said the Pfizer vaccine is well on its way for FDA approval.
~Max
ETA: Here’s an article I found,
ETA2: “When applying for an EUA, companies are required to submit two months of safety data, compared to six months for a BLA.” EUA=emergency use authorization, BLA=biologic license application (normal)
Well, they have been administered to hundreds of millions of people by now with no apparent side effects. We’re past the 6 month point and they are applying for full authorization, which should come shortly.
The CDC has a website dedicated to convincing you that vaccines are safe and effective.
Here is their direct answer to your question,
Long-term side effects are unlikely
Serious side effects that could cause a long-term health problem are extremely unlikely following any vaccination, including COVID-19 vaccination. Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose. For this reason, the FDA required each of the authorized COVID-19 vaccines to be studied for at least two months (eight weeks) after the final dose. Millions of people have received COVID-19 vaccines, and no long-term side effects have been detected.
CDC continues to closely monitor the safety of COVID-19 vaccines. If scientists find a connection between a safety issue and a vaccine, FDA and the vaccine manufacturer will work toward an appropriate solution to address the specific safety concern (for example, a problem with a specific lot, a manufacturing issue, or the vaccine itself)."
If you are skeptical of the veracity of any specific claim made above, I’m sure we can help you find the straight dope.
The emergency use authorization looks for the same safety data as a full approval, just over a shorter time period. They were looking for side effects, adverse reactions, etc., in the two months after administration in the EUA, whereas the full application looks at, minimally, six months. However, it is quite rare to have a side effect to a vaccine four or six months after the shot; I don’t know that there has ever been a vaccine where the side effects waited more than a month or six weeks to manifest, and certainly it is not common. (That is of course quite different from medications that you take on a continuing basis, but substantially the same approval rules apply to one/two-shot vaccines and every-day-for-the-rest-of-your-life pills.)
Pfizer has already submitted their application for full approval, and Moderna announced their intention to do so this month. It’s fairly likely that one or both will receive full FDA approval yet this calendar year; however, full approval is more than just safety data (they’ll be negotiating the exact language that goes on the label, and what kinds of advertising the companies can do, and that sort of thing), so it takes time.
Yes. But they’ve been given to an enormous number of people, and we now have quite a lot of data at 6+ months, and there have been no red flags. I’ll be astonished if full approval isn’t granted within a few months.
The clotting issues were with the AstraZeneca and J&J vaccines, not the mRNA ones (Moderna and Pfizer.) I haven’t heard of any negative effects from the mRNA vaccines.
But the reality is that we have not yet reached that point, and I am bothered by the governors et al who are insisting that everyone should get vaccinated because it is already known to be safe.
Technically, even after the FDA approves a vaccine that does not logically imply the vaccine is safe.
All inductive conclusions are subject to criticisms of faulty generalization. If you wait for X weeks of safety data, you cannot know for sure that the vaccine is safe over X+1 weeks. You have to call it a day at some point. According to governors and the CDC and their sources, it’s safe.
While we cannot ever say that anything is absolutely save, we can say with confidence that getting vaccinated is much safer than not getting vaccinated and risking to get the disease itself.
You’re focusing on the emergency piece and not the approved piece.
Approval required testing for efficacy and safety- but the required length of testing and numbers tested is lower than for full approval. There are specific procedures and protocols that govern this- it’s not just a whim.
This happens in tests already- if a life saving drug in trial is showing amazing results, they move placebo or untreated groups onto the drug early, to not deny them efficacious treatment, while the testing protocols finalize.
The right-wing blogosphere and twitter feeds are filled with references to “unapproved vaccine” and “experimental vaccine” and the like, trying to create doubt on the safety of the vaccines in use in the US. It appears to me that these right-wing twitters specifically do not want the pandemic to end. I guess they don’t want Biden to be seen as ending a pandemic that Trump was unable to do anything about.
Ironic, isn’t it, that these are the same folks that initially tried to float the idea that the pandemic was a hoax, that Covid was just a cold (and not even a bad one at that). That quickly morphed to the notion that masks and distancing were completely ineffective at slowing the spread of this (non-existent) disease, so such restraints were an ungodly affront to their freedoms. Now, when there is a safe, non-onerous , and clearly demonstrable prevention available, it is rejected because it was rushed through approval (by former-president Trump).
As has been mentioned by others, the EUA is simply a way for the FDA to grant rapid approval of new medicines and treatments when a great need has been demonstrated (the Emergency part of EUA). This pandemic certainly qualifies as an emergency. Given the vast number of people who have been vaccinated, and the careful, watchful eyes that have been looking for unexpected reactions to the vaccine (by both proponents and opponents) and I am pretty sure it has been proven that the individual risks encountered by getting the vaccine are far less than those one faces by not getting the vaccine. In addition, the more individuals that get the vaccine, the more the risk to the general population is reduced.
It’s been abundantly reported that the vaccines were approved under EUAs. It isn’t necessary to emphasize that in every story about encouraging vaccination, especially as there has been such extensive experience with them with only very rare potentially serious reactions in some cases.
I’ve also seen reporting on prospects for full FDA approval, so it hardly seems like a “coverup” is going on.
Okay, let’s look at it this way: Given that the vaccines do have emergency approval, but do not have general approval, what are the lingering questions that prevent the agencies from giving the general approval right now?
If it is simply a matter of protocols and rules that require a certain amount of testing, and that threshold has not yet been reached, then maybe the protocols and rules need to be changed, to reflect the view that this amount is sufficient for general approval?
Why? We were/are in an emergency and emergency approval was beneficial. When we’re not in an emergency situation there’s no need to modify the current protocol.