One of the questions I keep seeing is why did it take so long for FDA approval of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty? The answer is complicated, but the basic issue is that the FDA is very conservative in approving drugs – I bet that will surprise everyone.
I’m going to delve into a couple of issues with the FDA and its approval of the Pfizer COVID-19 vaccine. Even though some people argue that it took too long to go from the Emergency Use Authorization (EUA) to full approval, it was, in fact, fairly rapid. Remember, clinical trials only commenced maybe 15 months ago, so this is warp speed compared to the usual vaccine timeline that may be nearly 10 years.
Many of us thought that it would take up to three years before we had COVID-19 vaccines available – I’m willing to eat humble pie on blowing that prediction, but it’s amazing what happens when governments, scientists, and pharmaceutical companies can do when they are all focused on a common goal. Not for nothing, but why can’t we do the same thing with climate change – a lot more of us are at risk of that than COVID-19, but I’ll leave that for another day.
Let’s take a brief look at why some of you are wondering why it took so long for the FDA approval of the Pfizer COVID-19 vaccine.
Let’s first review the EUA
As I have discussed before, the Pfizer EUA underwent a thorough review by FDA officials and a vaccine expert committee called the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
There is a myth pushed by the anti-vaccine crowd that the FDA summarily approves vaccines without even a cursory review. They think that the FDA trusts anything Big Pharma submits to them without thinking. That couldn’t be further from the truth.
Every drug, including the Pfizer/BioNTech COVID-19 mRNA vaccine, is always reviewed by an expert committee of scientists alongside career FDA scientists. The reviews are generally thorough and deliberate.
For vaccines, VRBPAC, which is made up of approximately 30 experts in vaccines, public health, and statistics. There is also one vaccine industry expert and a consumer representative on the panel. These are the best and brightest individuals in vaccine science.
According to the FDA, the committee is charged with:
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.
This committee makes recommendations to the FDA director as to whether a drug (including vaccines) should be approved for the EUA (and eventually a full approval, such as what recently happened with the Pfizer COVID-19 vaccine).
FDA approval process for the Pfizer COVID vaccine
From my perspective, I thought the full FDA approval for the Pfizer COVID-19 vaccine was rather fast and efficient. But given the anti-vaccine rhetoric that kept claiming that the vaccine was “experimental” because it hadn’t received full approval, many pro-vaccine advocates were dismayed by the rather slow process to get approval. The country had huge costs because it took even a few months to get full FDA approval.
The delays in vaccinating military individuals and the so-called fence-sitters, who were not necessarily opposed to the vaccine but wanted full FDA approval, along with the outright COVID-19 vaccine refuseniks probably allowed the Delta variant to spread throughout the country much more quickly. About 95% of Americans who died of COVID-19 could have been saved by the vaccine over the past few weeks.
So why did the FDA take so long?
The answer is kind of short – bureaucratic caution.
I know the typical belief out there is that the FDA is somehow in Big Pharma’s back pocket, and they do whatever Big Pharma tells them to do. Although there are certainly some problematic issues with the FDA’s relationship with Big Pharma, in general, it is very difficult for any new drug to get FDA approval. Only around 12% of drugs that enter phase 1 clinical trials ever get full approval. If the FDA is in Big Pharma’s back pocket, I think they escaped long ago.
Although we will never know for sure, we can speculate on the many reasons the FDA chose to be very deliberate in reviewing a full approval for the vaccine:
- They thought that a careful approval process may increase the confidence in the vaccine by the general public.
- They believed that they were already moving fast, since a typical final review takes over 12 months, and they did this in less than 4 months after receiving the application from Pfizer.
- Anti-vaxxers will beat up the FDA if they went too fast.
From a scientific point of view, the FDA had all the data it needed with the EUA application in December 2020. Pfizer may have provided a little more safety and effectiveness data with its clinical trials since the EUA application, but it probably wasn’t much.
I know a lot of people are saying that the FDA needs to revamp its processes to speed up development. I am not a fan of that – in fact, unless there is a drug that is needed immediately such as the COVID-19 vaccine, the FDA should be deliberate and careful. Many of us feared that if the FDA sped up the approval of the COVID-19 vaccines without the scientific review, as Trump was pushing last fall, something could have been missed destroying the confidence in the new vaccine along with all other vaccines.
Of course, anti-vaxxers say it was too fast
The anti-vax crackpot, Peter Doshi, has just published a blog post at BMJ (no, it’s not peer-reviewed, it’s nothing more than an opinion piece) stating that:
The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines.
When I have more energy, I’ll take on his nonsense at a later date, but his whining is pointed at something that has become a pseudoscientific trope with the anti-vaxxers – long-term follow-up is necessary to know if the vaccine is safe and/or effective. Of course, if the follow-up is 12 months, they will demand 24 months. And if it’s 24 months, they’ll demand 36 months.
Anti-vaxxers are the kings and queens of moving goalposts. They are the perfect examples of the argument from ignorance, a logical fallacy that states that a proposition is true from the fact that it is not proven to be false (or alternatively, that a proposition is false because it is not proven to be true).
But I will let you in a scientific secret – vaccine effects are always temporally short-term. They have one purpose, to “train” the adaptive immune system to “remember” an antigen from a targeted pathogen, in this case, SARS-CoV-2, the virus that causes COVID-19.
After it does that, the vaccine disappears from the body, and it cannot do anything that is claimed to be a long-term effect.
Peter Doshi, if he were only a real scientist with a real background in vaccine scientist, would know this. Instead, he uses his BMJ bully pulpit to pretend to the anti-vaccine crowd that he’s publishing real science rather than his opinion on the FDA approval of the Pfizer COVID-19 vaccine.
And let me remind you that the Vaccine and Related Biological Products Advisory Committee, made up of the best independent vaccine scientists in the USA reviewed the raw data along with expert statisticians and concluded that the vaccine was 95% effective and extraordinarily safe. Does Doshi arrogantly believe that his anthropology degree, and approximately zero scientific background in vaccines, have found a “gotcha” that was overlooked by VRBPAC?
I don’t think so.
Despite Peter Doshi’s claims, the FDA approval process for the Pfizer mRNA COVID-19 vaccine was not rushed. Was it fast? Yes, but it still contained the normal review of data for safety and effectiveness.
A lot of the anti-vaccine crowd loved to call the vaccine experimental because it didn’t have FDA approval. Now, they’ll move the goal post and say that the FDA approved it too quickly and wasn’t thorough.
It was thorough. Very thorough.