One of the enduring myths about vaccines is that they’re rushed to market, which has continued with COVID-19 vaccines. This myth doesn’t arise because the anti-vaxxers have some “gotcha” information about these vaccines, it’s because they are intent on pushing fear, uncertainty, and doubt.
If you read my articles since March about the development of this vaccine, I was very troubled about the speed of development. Most vaccines take 5-10 years to develop, mostly because we want a better handle on the expected effectiveness and to uncover any potential (and extremely rare) serious adverse events.
But were the COVID-19 vaccine rushed? Not really. Basically, two massive resources – money and brainpower – were thrown at developing a vaccine so that we could stop the inexorable march of the pandemic. The best scientists in the world collaborated with the best pharmaceutical companies with the backing of the richest countries to develop and manufacture safe and effective vaccines.
It wasn’t a magical process where scientists pulled ideas out of thin air to make these vaccines using dangerous technologies. They didn’t.
We know how to train the adaptive immune system to prevent pathogenic diseases with vaccines using all kinds of technologies. Once we were able to isolate the SARS-CoV-2 virus and determine what parts of its structure were the most immunogenic, we knew what to do, it wasn’t a huge mystery at that time.
mRNA vaccines were not rushed COVID-19 vaccines
Moderna, which has been researching and developing mRNA vaccines for a variety of diseases, already had the science to allow it to pivot quickly to developing a vaccine for COVID-19. BioNTech, which helped develop the Pfizer vaccine, had a similar experience in mRNA vaccines.
Moderna has seven mRNA vaccines for a variety of diseases under development for over 10 years. Many of these vaccines are in late phase 1 or phase 2, so Moderna itself has extensive experience with the mRNA vaccine that gave them an advantage in development.
However, the research on mRNA vaccine technology goes back to 1990, when scientists determined that they could use mRNA messages to induce mouse cells to produce. The mRNA vaccine technology has been developing extremely rapidly over the past 20 years. And there is a large body of preclinical data that has accumulated over the past several years, and multiple human clinical trials have been initiated.
It is simply one of the many myths about the mRNA vaccines that want you to believe that they were rapidly developed in a matter of a few months. This vaccine technology has been around for a long time.
Because of our ability to sequence the DNA of the SARS-CoV-2 virus, we were able to determine which sequences produced the S-protein and quickly get the mRNA sequence. This is what sped up the development of the vaccine, not cutting corners. The technology was there and the vaccine was almost “easy” to produce.
Although it will take time to understand the effectiveness of mRNA vaccines, the safety of these vaccines has not been circumvented by the speed of getting the mRNA vaccines to us.
The other vaccines that may soon become available in the USA, Europe, and other developed countries include ones from JNJ Janssen, AstraZeneca, and Novavax also use well-understood technology.
JNJ and AstraZeneca have developed viral vector vaccines that use an unrelated virus, that does not cause disease, to transport some of the SARS-CoV-2 genes into the body in order to stimulate an immune response. The hepatitis B vaccine employs this particular technology to prevent the cancer-causing virus.
Novavax actually isolated the S-protein and utilizes that as the antigen to induce an immune response, another typical vaccine technology.
These technologies for the new COVID-19 vaccines were anything but rushed. It was fast because we needed to save lives, but it wasn’t rushed.
So, we can trust these vaccines?
Yes, the process to bring these new COVID-19 vaccines seemed fast, but they weren’t rushed to cut corners in safety or effectiveness. That’s simply a myth because the anti-vaccine crowd wants us to believe that there is something wrong with these new vaccines.
There are several reasons why we can feel confident in the development process for these vaccines:
- Despite the claims of those like Del Bigtree, the FDA carefully examined the clinical trial process for all of these vaccines, and they found them to well-controlled.
- The clinical study data was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). VRBPAC is made up of experts in vaccines, public health, and statistics. There are around 30 individuals on the committee (although not all attend every meeting) including one vaccine industry expert (a clinical physician-scientist, not some executive) and one consumer representative, in this case, a respected attorney who concentrates on healthcare issues.
- Researchers had a head start with the related coronaviruses, SARS and MERS, over the past 15 years or so.
- The clinical trials are huge – over 150,000 individuals have been included in the five clinical trials for the five vaccines mentioned in this article. That is far above the 3-5 thousand included in most clinical trials.
- Regulatory agencies in the USA, Europe, Japan, Australia, and Canada have reviewed the data for these clinical trials. They have all come to the same conclusion – the safety and effectiveness profiles are far higher than the risk of the disease.
My only concern is that long-term clinical trials are necessary to determine the long-term effectiveness of these vaccines. We don’t know how long the immune response will be. We don’t know whether mutations might reduce the effectiveness of the vaccine. For example, there are early concerns that the AstraZeneca vaccine may not be effective against the South African variant of SARS-CoV-2. That could be a crucial problem with that and the other vaccines.
I do not have a similar concern about the safety profile of these vaccines. The clinical trials did not have any safety signals for serious adverse events. And despite the wild claims of the anti-vaccine crowd, long-term safety issues with vaccines are extremely rare, if not nonexistent.
Yes, in a perfect world, we should have had 10 years to study, develop, and manufacture this vaccine. But we didn’t – thousands of people are dying every single day from the virus. Even then the COVID-19 vaccines were not rushed – they were still studied and regulated like any vaccine.
As Dr. Vince Iannelli recently wrote:
Why wait to take your shot when COVID-19 vaccines are safe, with few risks, and are very effective? Why wait when most healthcare workers are at increased risk to get sick, can put others in their household at increased risk, and are fortunate enough to be at the front of the line to get vaccinated and protected?
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