I have tried to answer questions across the internet about COVID-19 vaccines, but it is getting frustrating. Some of these fantasies are as amusing and annoying as any of Del Bigtree’s ignorant claims about any vaccine on the market.
Although I have written an article, which is regularly updated, about coronavirus vaccine development, apparently people want to believe that there are miraculous, magical COVID-19 vaccines just around the corner.
Here’s a list of FAQs debunking some of the most pernicious myths about COVID-19 vaccines.
COVID-19 vaccines are just around the corner
In alteration of the reality distortion field of vaccines, I’ve noticed that a lot of people truly believe that vaccines are easy to develop, and we should have one of the many COVID-19 vaccines in just a few months. Many are stating that we shouldn’t bother with safety and effectiveness studies because this is an emergency.
That’s not how it works.
- It takes time to isolate the virus and then determine how to develop a vaccine that safely causes the immune system to react to the vaccine. That could be isolating an antigen on the virus coat, determining the right adjuvant to stimulate the immune system or a dozen other requirements.
- All vaccines in the USA (and most other countries) have had several years of clinical trials to establish safety and effectiveness. Anti-vaxxers love to claim that vaccines haven’t been very well studied, using all kinds of strawman arguments with little basis in science.
- If we haven’t studied the vaccines thoroughly, then there would be a high amount of vaccine hesitancy, something we can’t risk with potential COVID-19 vaccines. To build herd immunity, we might need 90-95% of the population vaccinated.
- If we don’t have strong evidence that the vaccine is effective, it could mean that we have a false sense of security from the vaccine, but a subsequent surge of infection across the world could lead to unnecessary deaths.
Vaccines take a long time to develop. They take a long time to get through clinical trials. Sure, we can shorten some of the timelines by throwing boatloads of money into the process to speed up the recruitment of test subjects and to analyze data.
However, to adequately determine safety and effectiveness, we need to wait for several months, maybe even up to a year. To ascertain effectiveness, we need to observe the participants during times where they might be exposed to the virus. You can’t intentionally expose them to coronavirus, that would be unethical and immoral – probably illegal.
If I were to bet when COVID-19 vaccines would be available in the USA and other developed countries, it could be up to five years. The HPV vaccine was first developed in 1992, received FDA approval in 2006, and was launched to much of the world during 2007. That was 15 years from beginning to launch, and the HPV vaccine is probably the safest, most effective, vaccine on the market.
A clinical trial for a vaccine means it’s ready to go
This myth is particularly irritating. For some reason, too many people believe that once a vaccine or any drug enters clinical trials it must be safe and effective.
I think that some people, obviously not the anti-vaxxer crowd, believe that if it’s ready to be used on humans, we mostly know it must be great. Except that’s not how it works.
Most clinical trials are structured like this:
- Phase 1 – the COVID-19 vaccines are injected into “healthy volunteers.” The study is not blinded or randomized. This trial tells us almost nothing about effectiveness (unless everyone contracts SARS-CoV-2 then we’ll know it doesn’t work) and almost nothing about safety. It’s really just done to tell researchers if there are major safety or effectiveness issues. No regulatory authority will approve a vaccine based on Phase 1 results. Or at least they shouldn’t.
- Phase 2 and 3. These are generally randomized, double-blind studies – usually, it compares one group that has been vaccinated to another group that receives a placebo or an antecedent vaccine (of which, there are none for COVID-19 at this time). Phase 2 usually includes a few hundred patients, and it allows researchers to determine if there are any issues that may cause them to suspend the trial. The Phase 3 study includes a few thousand, and it is usually considered the pivotal study that will convince the FDA or other regulatory agency to approve the new vaccine. Sometimes these clinical phases are combined.
These are scientific experiments that attempt to answer two questions – is the new vaccine safe and is the new vaccine effective?
Before we perform these studies, we cannot be assured that any of the COVID-19 vaccines are safe and effective. I keep hitting this point about clinical studies – about 87% of drugs that enter clinical studies fail to get regulatory approval. Now, that might be somewhat less with vaccines, but more fail than succeed.
Vaccines are easy to manufacture
Vaccine manufacturing is incredibly difficult. There are only a handful of facilities that can manufacture millions of doses of vaccines, let alone the billions that might be necessary for COVID-19.
Here are all the considerations that most people don’t understand:
- Coronaviruses have to be produced in massive amounts to be put in the vaccine, depending on the type of vaccine being produced.
- The specific formulation of the vaccine has to be determined
- Whether the new vaccine can be manufactured in current facilities.
- Whether manufacturing the new vaccine will restrict production of currently available, and just as important, other vaccines.
- Whether there is enough current manufacturing capacity to make as many COVID-19 vaccines as we think will be necessary.
I can imagine that there are thousands of engineers across all of the companies that produce vaccines having sleepless nights trying to figure out how to do this. And no, it’s not easy, and it could take years to produce a new vaccine in amounts needed.
We should take a risk because COVID-19 is dangerous
I engaged with a random Dunning-Kruger in a comment section (not here), who was arguing that we shouldn’t bother with these studies because we need to take risks to get vaccines quickly out to the people.
That is wrong on many levels.
As I mentioned previously, if the vaccine doesn’t work, then we have created a false sense of security. We absolutely need to know that the vaccine is effective – if it doesn’t work, then we will have to continue with public health recommendations that we have now.
Also, we need to know if it is safe. In fact, we have not been able to develop vaccines for SARS and MERS which are caused by other coronaviruses closely related to SARS-CoV-2. One of the numerous SARS vaccine candidates showed a respiratory immunopathology that was considered dangerous. Eighteen years after the discovery of SARS, we still don’t have a vaccine, and we still don’t know how to produce one.
Given what we know, taking a “risk” by quickly launching COVID-19 vaccines is dangerous from both a safety and effectiveness perspective.
Moderna has a vaccine already
A small pharmaceutical company, Moderna, announced that they have begun a Phase 1 clinical trial for a SARS-CoV-2 vaccine called mRNA-1273 on 16 March 2020. The vaccine works in a novel way that actually encodes for a protein on the virus which should induce an immune response.
Apparently, the company didn’t perform (or has not published) any preclinical studies to show whether this method worked in an animal model. I suspect that there was no preclinical work given the amount of time between the creation of the mRNA-1273 vaccine and the beginning of a Phase 1 clinical trial.
The FDA has 30 days to review preclinical data during which time they can block the start of the study. It’s possible that the FDA chose to ignore this issue (which bothers me greatly) in an effort to get a vaccine to market. I have tried to find information as to why this happened, but it appears to be a black hole (so if you have information, please tell me in the comments).
Here are some issues that should put a bit of a damper on the optimism for this vaccine:
- See above about Phase 1 clinical trials. They tell us almost nothing. Also, this trial is going to take a year to complete. Just in case I’m not clear, I wrote one year.
- Moderna has 9 therapeutic vaccines in development. Not a single one of them has passed the Phase 2 stage, and none have received FDA approval. I would be much more optimistic if they actually have been able to turn their mRNA technology into actual vaccines. And many of these vaccines have been in development for years, so why should I not be skeptical about their ability to deliver a vaccine?
- If all goes right, Moderna will complete the Phase 1 trials by February 2021. They then apply for approval to begin Phase 2 and/or Phase 3 trials, which might start by summer 2021. It could take another two years, if all goes well, to get results from those trials. This timeline might be able to be compressed with lots of money, but that money isn’t going to come unless some very positive results showed up in early Phase 2/3.
Ignoring press releases, which have one purpose and that’s to get investors interested in their wild claims, we have little evidence that this vaccine will work. We have no information on how long it will take to scale-up manufacturing for their vaccine. We will not know much about the safety and effectiveness of the vaccine for years.
For those of you who want a vaccine (and I do), COVID-19 vaccines are not around the corner. It’s going to be years before we get one unless we take a lot of shortcuts and greatly reduce regulatory oversight.
And guess what happens if we do that? Yes, the anti-vaccine zealots will make all the same claims about a new coronavirus vaccine as they do with all of the other safe and effective vaccines that we now have.
If we shortcut the process and take “risks,” the anti-vaxxers will actually have a valid point. And I don’t want that world.
I don’t know when we’ll have our first vaccine for this disease, but it may not happen until after the pandemic dies out because most people are infected and millions of people are dead. That’s why public health initiatives are so critical now and in the future.
But I’d stop betting that a vaccine is just around the corner. Unless everything I know about vaccine development should be tossed into the waste bin, I’m not seeing any way that a vaccine will be here for years, unless everything goes right. And it almost never does.
- Tseng CT, Sbrana E, Iwata-Yoshikawa N, Newman PC, Garron T, Atmar RL, Peters CJ, Couch RB. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One. 2012;7(4):e35421. doi: 10.1371/journal.pone.0035421. Epub 2012 Apr 20. PubMed PMID: 22536382; PubMed Central PMCID: PMC3335060.
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