This article about the Moderna coronavirus vaccine candidate has been updated and published here.
If you have been paying attention to the news, you’ve probably seen reports of the Moderna coronavirus vaccine candidate that is getting everyone all excited about a vaccine “real soon now.” I’ve even seen so-called pro-vaccine people, who ostensibly should be following science, breathlessly cheer them on.
Instead of waiting for actually published scientific results, so that we can see if the Moderna coronavirus vaccine actually shows any safety or effectiveness, people are demanding it “right now.” If this were someone pushing an anti-malarial drug as a “cure” for COVID-19, we’d be relentlessly mocking them. And we do.
People want “hope,” as opposed to possibly endless cycles of bouncing between opening up and closing down in response to the pandemic. But hope isn’t a part of the realm of scientific research – that’s best left to those who believe in the Age of Aquarius.
As anyone who reads my blog knows that the only thing that matters to me is published scientific evidence. And by published, I mean in a respected, peer-reviewed journal. Sure, I don’t need scientific evidence to support my belief that the New York Mets should be thrown out of baseball, because I hate the team – that’s just an opinion.
But when it comes to vaccines, we have built an amazing system of bringing the most effective and safest medical advances to humanity. Despite the misinformation and FUD of the anti-vaccine zealots, the safety and effectiveness of modern vaccines are settled science.
I’m not willing to sacrifice that for a vaccine that may not be effective or safe. That’s why I want to take a very critical look at the Moderna coronavirus vaccine. And I think there are more reasons to be skeptical than not.
Moderna focuses its vaccine research on mRNA, or messenger RNA, technology. mRNA are molecules in the cell that corresponds to DNA sequences and carries that information to be “read” by a ribosome to produce a protein.
Moderna’s vaccine technology relies on mRNA to kickstart the endogenous production of proteins similar enough to the viral antigens that trigger the body’s adaptive immune system to produce antibodies effective against the actual target. In other words, instead of injecting a live-attenuated vaccine, like the measles vaccine which contains weakened measles virus, the Moderna vaccines inject mRNA fragments that are selectively delivered to cells to produce the viral antigens (but not the whole virus, of course).
Moderna has several similar vaccines in clinical trials, but none have received FDA approval as of today.
Kaiser-Permanente has registered a phase 1 clinical trial for the Moderna coronavirus vaccine, which began in late March. The phase 1 trial would include 45 health adults separated into three groups receiving different doses, low, medium, and high.
Moderna has stated that they will be entering phase 2 clinical trials soon, but it has not been registered as of today. Typically, phase 2 clinical trials require FDA clearance after review of phase 1 results, but these are different times, so who knows.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
It does not mean that the Moderna coronavirus vaccine gets approval without showing that it is safe and effective. It doesn’t mean that Moderna can skip clinical trials just because. It just means that Moderna can get an expedited review along with more frequent meetings with the FDA to go over issues. In bureaucratic parlance, it just means that Moderna’s NDA goes to the top of the pile, which can reduce the time to market by a few months.
At this point, this is the length, breadth, and depth of what we know about the Moderna coronavirus vaccine. There is no published data. There is no FDA approval. There isn’t even a complete phase 1 clinical trial.
And going back to what I mentioned above, all I care about is scientific evidence that I can read from a neutral, unbiased source. We don’t have that.
So here are my issues in somewhat order of skepticism:
- Moderna press releases. Almost everything we know about the Moderna coronavirus vaccine is from claims made by Moderna itself. We don’t have any published articles where we can examine the data. On the hierarchy of scientific research, press releases rank just above Natural News as a source of scientific information, and many real vaccine researchers dismiss them outright. Furthermore, Moderna is a small biopharmaceutical company, so they have an incentive to boost their stock prices. Larger pharmaceutical companies, also working on coronavirus vaccine candidates, are very quiet, because they are more conservative about public commentary about drug development – it doesn’t mean that they aren’t doing anything, it just means that they know the consequences of missing on promises.
- Corporate executive claims. There’s an old trope that you know when a Big Pharma executive is lying – when they start speaking. However, as I mentioned above, most Big Pharma executives are careful in their claims. Boosting stock prices when you aren’t sure of the potential of your new drug can lead to serious actions by various agencies across the world. Small Pharma executives don’t seem to have that built-in.
- Operation Warp Speed. As I’ve discussed before, rushing vaccine development has a lot of consequences from missing safety signal and long-term effectiveness to causing concerns from people who are on the fence about vaccines. Of course, committed anti-vaxxer opinions about new coronavirus vaccines will not be relevant since science is irrelevant to them. Ironically, a former Moderna executive and board member is heading Operation Warp Speed for Donald Trump. Let that sink in.
- Manufacturing. I’ve written extensively about manufacturing a new vaccine – I think that it’s going to be difficult to produce hundreds of millions of doses of vaccines easily, because of the lack of excess capacity in the world. I constantly worry that the capacity that goes to make the MMR or other vaccines will be switched to the coronavirus vaccine. And building new capacity could take years, because manufacturing lines take months, if not years, to spec out and acquire, along with the limited capacity of raw materials like pharmaceutical-grade glass for syringes and vials.
- mRNA technology. I am not opposed to new biotechnology – I am firmly in favor of GMO biotech because the science says it’s safe and useful to humanity. On the other hand, using mRNA to harness the cellular manufacturing process to create the antigen is a new technology that hasn’t been thoroughly vetted for long-term complications, although I don’t expect any. Since anti-vaxxers already whine about “DNA in vaccines” based on pseudoscience, I can imagine their complaints about mRNA in these vaccines. Moderna needs to address these complaints in advance.
- Only eight patients. Moderna is basing its claims about the vaccine based on a grand total of eight patients. Yes, that’s n=8, and it does not include any placebo group or anything else, because it’s a phase 1 clinical trial. In my world of statistics, n=8 is approximately at the level of anecdotes. As we keep telling the anti-vaxxers, anecdotes ≠ data. I refuse to accept that we know anything about this Moderna coronavirus vaccine candidate based on eight patients. We have no information about the other 37 patients in the clinical trial, and none of Moderna’s results have been published in a peer-reviewed journal, which would be a minimum requirement for this level of study. If they had even just given us a pre-print of the results of the 45 patients in the study, we might get a somewhat higher level of confidence in their claims. But let me reiterate – where is the data on those other 37 patients???
- Antibodies do not equal immunity. This is still an important consideration, but given the variety of conflicting information we have about reinfection by COVID-19, we should not consider antibody production from a vaccine to be an endpoint. It must be actually preventing the disease.
- Safety and effectiveness. These issues take time. I am so worried that Donald Trump, in his vain effort to show some leadership with his plague and with an ex-Moderna executive running point, will push the FDA to approve a vaccine that doesn’t work or has some dangerous short-term adverse effect. Or both. The phase 1 studies do not provide ANY evidence of safety or effectiveness. They might provide some signals that it works or is safe, but that takes time. And let’s remember one thing – most vaccines fail in clinical trials, so they have to be reworked numerous times before they are launched to the public. That’s why many people believe it will take over 5 years before we have a vaccine.
- Moderna’s track record with vaccines. Moderna has nine mRNA vaccines (not including their coronavirus vaccine) in clinical trials. Only one is recruiting for phase 2 trials. To be fair, past performance is not an indication of future results, but companies like Pfizer or Merck, who have coronavirus vaccines in development, have a long record of successfully bringing safe and effective vaccines to the market.
- Preclinical studies. Moderna claims (again without any published papers to back it up) that their vaccine conferred immunity to mice. That’s great, except, as I’ve written before, less than 1% of studies in mice lead to clinically useful claims. Preclinical studies are scientifically useful, but one should always reject them as some
I am frustrated by companies like Moderna (but they aren’t alone) who are making grandiose claims about their new vaccines. Many people believe that there is a vaccine “just around the corner,” which makes people believe we can end our public health concerns about COVID-19.
Moderna should be less worried about their stock prices – they should provide measured, accurate, and evidence-based commentary about the Moderna coronavirus vaccine.
I believe that we need a vaccine to have herd immunity against COVID-19. And I want one as soon as possible. But I cannot stress this enough, buying into preliminary, unpublished data from a pharmaceutical company press release gives us false hopes. And that’s not what we need in today’s world.
And one last point, because I’ve seen anti-vaxxers quote mine my articles about coronavirus vaccines. If the Moderna coronavirus vaccine gives us powerful evidence in phase 3 clinical trials that it is safe and effective, I will be first in line to get it, if they can actually produce enough supply.
I only want everyone to demand the same level of safety and effectiveness that we have for every single vaccine available today – it’s settled science.
Do I want the vaccine to get to market as fast as possible? Absolutely yes, because every day that passes before we have a vaccine may mean thousands of deaths.
Do I want to cut corners? Absolutely not. That’s why I am very happy that Pfizer, a real company with a real background in producing drugs and vaccines, has started a large phase I/II clinical trial in the USA for a vaccine candidate.
We should do everything to get a new coronavirus vaccine, that’s why this one is being fast-tracked by the FDA. But that designation doesn’t mean Moderna gets to cut corners, it just means we can save months on regulatory approval.
I want Moderna to succeed. But I’m very skeptical of their claims at this point. I used to say “call me when phase III clinical trials are completed and published.” I still want that, and maybe they can deliver on that. But right now, they haven’t.
As the LA Times has written:
One hates to be the bearer of bad news, which in this case means placing Moderna’s announcement in context, but the truth is that Moderna hasn’t announced a vaccine and the path to developing one remains long and tortuous.
Whether Moderna’s early trial will result in a vaccine, or when, remains highly uncertain; most drugs that deliver promising Phase 1 clinical trial results end up failing in the final analysis. There’s no reason to expect that this one will necessarily buck the odds. Moderna’s vaccine is one of many being tested.
There are over 110 coronavirus vaccines in development, along with nine in clinical trials – even though most will probably never see the light of day, a few will meet the exacting standards of safety and effectiveness. Those of you who want hope, that’s where you should place your bets – on the whole field.
I’d love to be proven wrong about the Moderna coronavirus vaccine. But, right now, I am skeptical.
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