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Recently, a tweet was made by a Canadian politician, containing a video of a Canadian Member of Parliament, Anthony Housefather, who made some fairly outrageous claims regarding the production of Covid-19 vaccines. Among those claims are the following (quotations of the words of Housefather in the video):

  • "Companies were being told to rush [COVID] vaccine [development (in the video the word "production" is used, but in context it is clear he meant "development")]"
  • "[Companies were told to] do testing in an unprecedented way"
  • "[Companies were told to do testing] in a way they don't normally do it"
  • "[Vaccine production companies] didn't do the type of testing that normally takes these drugs years to come to market"

In the context of the rest of the video, the above quotes definitively mean that Housefather believes that there was a lack of adequate testing of Covid vaccines; the word "unprecedented" and "don't normally do it" are not meant to be positive descriptors in this case.

Some background: During the pandemic, we (at least in Canada) were told that the vaccines were developed according to proper standards and the only part that was "rushed" was the approvals process; rather than taking years to take their turn in a never-ending pharmaceutical pipeline, these vaccines were put "to the top of the inbox", as it were, to get them out the door faster. However, we were told, the testing and scientific development that went into them was still the same process that goes into all vaccines and medical treatments, and furthermore any questions thereof regarding any unconventional items in the approvals process was anti-vaxx propaganda. It is therefore noteworthy that a member of the ruling party in Canada is saying these things, when during the pandemic they were quashing these sorts of statements.[citation neeeded]

Question: What evidence exists, if any, to suggest that the scientific development, including testing, of Covid-19 vaccines, was in any way "rushed" or done in any form of unconventional or "unprecedented" way? Concerns regarding the governmental approvals/regulatory processes for such are out of scope of the question, I am asking only about the scientific (development, clinical trials, etc) part of the development.

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  • I find the quoted claims less surprising than your unquoted counter-claims in the "some background" para. But anyhow "testing in an unprecedented way" is just typical inflammatory, but ultimately meaningless politicians' speech. Then you say "the only part that was "rushed" was the approvals process". But what do you think that approval process normally involved, just filing the paperwork in triplicate, and just that was skipped for Covid?
    – Fizz
    Feb 24 at 23:46
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  • @Fizz Your point is well made. However, the person being quoted is a member of the party who /supported/ the vaccine, including instituting vaccine mandates and so on. I would expect such "inflammatory" rhetoric from the opposition, not from the main party. Hence why the statements are noteworthy. As to your second comment, yes, that is precisely what I think that approvals process normally involves. Do you have something to clarify in that respect? Please write it into an answer.
    – Ertai87
    Feb 24 at 23:53
  • A world wide pandemic was declared and the world should wait years for something to help control it? Also just because someone is a member of a party that supports something doesn't mean that all members feel the same way.
    – Joe W
    Feb 24 at 23:54
  • @JoeW Nobody is saying anyone "should" or "shouldn't" anything. I'm simply asking if this was the case, not making judgments about it. Even if the development was fast tracked, as you note, there may be other considerations which make it "worth doing" (for some value judgment thereof); that doesn't change the fact that it was done. I simply want to know if it was done.
    – Ertai87
    Feb 24 at 23:56

2 Answers 2

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Disclaimer: I know nothing about Canada's approval process or what Canadian politicians said/promised was going to happen. As for the US, the question is alas ticky to answer or next to meaningless. If we're talking about the Emergency Use Authorization, which was granted prior to the mass vaccination of adults, that had some precedent, but

  • said precedent was only a post-9/11 thing (so not a long history to use for comparison), and mostly had been given for vaccines that few expected to be used on a wide scale in the US: against anthrax, Ebola, etc.

  • the standard for Covid-19 EUA vaccine approvals was set higher than for those prior EUAs, precisely because the Covid vaccines were expected to be mass used.

So, yeah, it was "unprecedented" in that/those regards, at least in the US. This was announced at the time as

“If we are going to do an EUA, it’s going to be like an EUA-plus,” Marks said. The bar for a typical EUA is relatively low — a company must show that a product may be effective — compared to that for full approval, which involves demonstrating substantial effectiveness in clinical trials. For Covid-19 vaccines, any EUA is “going to be closer” to full approval, Marks said.

It later came up in legal challenges, e.g.

Judge Leichty further examined the objection that the vaccines being mandated were only available under Emergency Use Authorization, and found this to be no impediment to the mandates on the basis that the Food and Drug Administration had employed an "EUA-plus" degree of examination, providing far more stringent requirements for issuance of the EUA than were required by law.

I'll note that your final request:

Concerns regarding the governmental approvals/regulatory processes for such are out of scope of the question, I am asking only about the scientific (development, clinical trials, etc) part of the development.

is rather at odds with the actual claim(s) you've quoted, which are about what companies were told to do/expect: "[Companies were told to] do testing in an unprecedented way". No company does testing for the sake of testing. They do it to get approvals, so you can't really split one issue from the other.

Now, if you're looking with a candle for some "unprecedented" aspects in more detail, perhaps this qualifies:

due to time constraints and the urgency to find a vaccine for COVID-19, Moderna and Pfizer did receive approval to run animal testing and early trials on humans at the same time, as opposed to fully completing animal trials before moving on to human trials. This, however, does not mean animal trials were skipped.

That bit was described by some academic researchers at the time as "very unusual", but understandable given the time frame constraints. One of the issues seems to have been that developing animal (in particular mouse) models for Covid-19 didn't look very promising then, so there was a chance the vaccine(s) may have worked in humans despite failing in mice.

So, if I'm to draw some conclusion from this: politician makes vague claim that interpreted in certain ways is true, but not incredibly meaningful for the general public.

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  • Regarding the testing vs approvals part of the question, I see what you mean. My point there was that, there exists a point at which the scientist does their testing regimen, whatever that is, then aggregates the results and sends it to a bureaucrat for analysis and approval. The former is the scientific part (in scope of the question), the latter is the administrative part (out of scope). I hope that brings clarity to what I intended to ask there.
    – Ertai87
    Feb 27 at 4:42
  • In context, when the vaccines went to market, Pfizer et al got special liability coverage from the government that they would not be held legally liable for any after-effects of the vaccine (at least such is the case in Canada, I believe it is also the case in the US but not sure). It is in the context of discussing this liability protection that the comments by Housefather in the question were made. Can you posit a reason as to why the testing regime in your answer might lead to the company getting liability protection in mass-market distribution? The reason I ask is because I can't.
    – Ertai87
    Feb 27 at 4:50
  • @Ertai87 For comparison: ~700k were inoculated with RRV-TV vaccine in 11 months until its license was recalled. Adverse effects arose in 1/10k patients and were discounted as statistically insignificant during clinical study phase - and this vaccine was not rushed. Some estimated 6kk+ patients in a month for the Phizer vaccine. Liability could be staggering, even if only one in 50k patients actually encountered problems after a year. Feb 27 at 6:32
  • @Ertai87 so the producers were likely not concerned with the "scientific" part of development, as you called it, but with the rushed distribution - there is always a chance for something to slip through the clinical studies, the potential liability scales with the number of inoculated, and the speed of distribution was indeed unprecendented. Feb 27 at 6:45
  • @Ertai87: ask separately about liability.
    – Fizz
    Feb 27 at 8:37
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The selected terms "rushed" and "unprecedented" are vague and effectively meaningless. Just about every single business venture can be described as "rushed", due to economic pressures to get to the market faster. Every single venture of any time can be described as "unprecedented".

During the period between the SARS-CoV-2 virus being discovered, and the first vaccines being put to market, there was incredible financial, political and humanitarian pressure to get effective, tested, safe, vaccines into production. It would be difficult to convey the sheer enormity of societal pressure placed on the medical industry during the early stages of the COVID-19 pandemic, if it wasn't for the fact that it was only three years ago, and I can rely on the readers of this site remembering it quite well for themselves.

In June 2020, the International Vaccine Institute (selected as a pro-vaccination source) published a blog article which quoted Dr. Sang-Hwan Seo, IVI’s Research Scientist & Lab Manager:

the speed from DNA sequencing until clinical trials was unprecedented.

This single quote shows that, in at least one way, development was both rushed and unprecedented.

What cannot be concluded from these terms that the vaccine testing was therefore of a lower quality. Using the simple project management triangle model, having a short deadline doesn't necessarily imply the scope of the testing was limited... as long as the budget could be extended. With US Government alone spending $18-23 billion (with a b) on vaccine development, the budget was not small.

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  • In context (as you commented, and indeed edited, my previous question on this topic, which has been deleted), the claim that the vaccine was "rushed" and testing was "unprecedented" led to the claim that the vaccine production companies should have reduced liability for any after-effects of the vaccine. If the "unprecedented" part of the vaccine production was how quickly the genome was sequenced, that should be a positive, not a negative, and should not lead the the companies in question asking for liability protection. Due to the context, this is not an informative answer.
    – Ertai87
    Feb 27 at 4:45
  • (also, this specifically is why I wanted to include the quotes about liability in the question, which you strenuously objected to in the comments thread of the previous question, so I removed them from this version of the question. Seems my initial inclination was correct)
    – Ertai87
    Feb 27 at 4:46
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    @Ertai87: There seems to be some confusion. I recommended you limit the question to one claim. I recommended that you do NOT select the "rushed" claim, because it was too obviously true (i.e. it would lead to an answer like this one). I suggested the one about "I want different conditions [with regard to liability of COVID vaccines]" would be the most interesting. Perhaps another question is warranted here?
    – Oddthinking
    Feb 27 at 6:31

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