Armando Simón, a retired psychologist, attempted to rebut an article of mine that criticized Florida Surgeon General Joseph Ladapo for his dangerous, anti-vaccine, anti-mask views and policies. Although Simón is entitled to his opinions, he is not entitled to fabricate his own facts, which he did repeatedly. Many of them are demonstrably false:
O He said, for example, that "COVID shots are not true vaccines in that they do not contain inert pathogens as is usually the case, but involve a novel treatment using mRNA." In fact, vaccines began to move away from "inert pathogens" as the active moiety more than 35 years ago. The active component of the hepatitis B vaccine Recombivax was (and is) the virus' surface antigen; it was approved by the FDA in 1986. (I was one of the FDA reviewers.) Other "subunit" vaccines based on a protein component of the virus have followed, including the pertussis and shingles vaccines. The Novavax COVID-19 vaccines (brand names: Covovax and Nuvaxovid) are subunit vaccines.
O Simón claimed that the COVID vaccines "did not go through the usual, mandatory, series of trials because of the hyperpanic that ensued," blah, blah, blah. As for the supposedly exaggerated "hyperpanic," let me remind him that, during the year in which the vaccines were being tested, "The official 350,831 COVID-19 deaths [in the U.S.] for 2020 reflects deaths in which COVID was the underlying cause of death." Yes -- 350,831 documented deaths.
More to the point, the vaccines did go through extensive preclinical and placebo-controlled clinical trials. Each was tested in more than 30,000 human subjects (and more than 10,000 subjects given a placebo) and found to be extraordinarily safe and effective, with efficacy measured by the ability to prevent (1) a positive PCR test for the virus and (2) at least one symptom. As of May 11 of last year, when CDC posted its final update, 81.4 percent of the U.S. population – more than 275 million people -- had received at least one dose of a COVID-19 vaccine. Even when the ability of those vaccines to stop transmission waned as new variants of SARS-CoV-2 (the virus that causes COVID-19) emerged, they significantly lowered the frequency of serious illness, hospitalization, and death. They continue to do so.
O Simón quoted the notoriously incompetent Ladapo (whose name Simón repeatedly misspelled, by the way) as "stating that the new boosters have had no clinical trials prior to putting them on the market, yet they are being promoted." Neither Ladapo nor Simón seems to understand that new, updated vaccines based on a previously proven platform are not subjected to large placebo-controlled trials, partly because they're unnecessary, but more importantly, because they're often not possible.
Why is that? As I noted above, the original COVID vaccines were tested at the height of the pandemic in clinical trials of more than 30,000 subjects each. Because there were huge numbers of infections throughout the country, it was not difficult to demonstrate a statistically significant difference in infection rate, hospitalizations, and deaths between the vaccinated and placebo-controlled groups.
I read the lengthy summaries of the vaccines' clinical trials that the FDA presented to its advisory committee in December 2020, and I agreed with the regulators and their external advisors that there was overwhelming evidence of safety and efficacy. But more recently, with the number of cases lower and some urgency about making available the new rounds of vaccines — which differ only by the substitution of a new piece of messenger RNA that directs the synthesis of a spike protein to elicit an immune response to the new circulating variants — there isn't time to mount huge trials to demonstrate prevention of infection and/or serious disease.
Instead, the vaccines are tested in animal models — vaccinated and unvaccinated animals challenged with virus — to demonstrate the ability to prevent infection and on a small number of human subjects (without a virus challenge) to show that they develop antibodies and other signs of an immune response and that there are no obvious safety signals.
There is more:
O Simón accused me of being "unaware of the fact that many individuals who have submitted to being injected with the mRNA concoction along with boosters – two, three, four times – have contracted the COVID virus anyway." Well, he seems unaware of several critical facts that are familiar to every physician, virologist, and epidemiologist. First, no vaccine is a hundred percent effective – flu vaccines, for example, are typically about 40-60% effective – so that so-called "breakthrough infections" are expected in some percentage of vaccinees. Second, he fails to understand that when an extremely large fraction of the population has been vaccinated, a significant number of new infections will be breakthrough infections in vaccinees. But even in those cases, the infections are less likely to result in hospitalization or death than infections in the unvaccinated.
O Simón's supporting sources (as evidenced by the links in his article) are notoriously unreliable and unscientific. They include The Epoch Times and Children's Health Defense, Robert F. Kennedy's aggressively anti-vaccine (and mentally unhinged) organization.
O Simón accused the CDC of promoting "face masks to prevent contagion even though it is well known they have no effect in prevention. Mask mandates were simply a symbol of conformity, of obedience." That is complete rubbish debunked here and here, with reliable references to experimental and real-world data.
O Simón asserts, "The authorities were wrong in every single aspect of the 'pandemic': the number of deaths, the number of deaths predicted, the lockdowns, the masks, the faux-vaccine, the treatments, the medications, the collateral damage, the refusal to give treatment to unvaccinated, the ethics." (Emphasis in original.) Only his Funny Farm Friends would agree with that statement.
I could go on, but I think I've made the point. Simón doesn't know what he doesn't know and is part of the fringe anti-vaccine, anti-mask, COVID-minimizing echo chamber. As a psychologist, it's a pity that he doesn't recognize that he's suffering from delusions.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA's Office of Biotechnology. Find Henry on X @HenryIMiller
Note: This is Part 1 of 2. The second part will discuss the regulatory obstacles to the commercialization of genetically engineered animals.