Henry I. MillerTexas’ political leaders recently have made some inconceivably irresponsible policy decisions. One will cause real public health damage to Texans, while the other simply reflects ignorance and will waste the state’s resources on a frivolous lawsuit.
In November, Texas Gov. Greg Abbott signed legislation that imposes a sweeping ban on COVID-19 vaccine mandates for all private businesses. It provides no exceptions for doctors’ offices, clinics, or other health facilities and has been described as “the latest blow to medically vulnerable Texans who rely on others’ immunization to shield themselves from highly transmissible viruses.” Cancer patients are especially vulnerable to infectious diseases, and in 2022, Texas’ M.D. Anderson Cancer Network alone had 175,719 patients, who accounted for 1.6 million outpatient visits. It is unthinkable that Texas would infringe on the freedom of the state’s private health care providers, from M.D. Anderson down to individual physicians, to establish policies that are known to prevent their employees and patients from contracting a potentially lethal infection.
Also in November, Texas Attorney General Ken Paxton filed a lawsuit accusing pharmaceutical company Pfizer of “unlawfully” and “intentionally” misrepresenting the effectiveness of its COVID-19 vaccine and attempting to censor its critics. The suit alleges that the company “engaged in false, deceptive, and misleading acts and practices by making unsupported claims regarding the company’s COVID-19 vaccine in violation of the Texas Deceptive Trade Practices Act.”
The pivotal allegation is that “[t]he pharmaceutical company’s widespread representation that its vaccine possessed 95% efficacy against infection was highly misleading.” The suit also accuses Pfizer of conducting a “scheme of serial misrepresentations” and seeks $10 million in reparations.
Paxton and his staff seem to have spent too much time listening to pundits on Fox News and too little time performing due diligence. Contrary to much of the blather from anti-vaccine, COVID-minimizing armchair experts, the first round of COVID vaccines – which were developed and tested with the help of the federal government’s Operation Warp Speed – did prevent infection. That was clearly evident from the summary of Pfizer’s clinical trial data presented by FDA to its vaccines advisory committee in December 2020.
In the pivotal clinical trial, which included more than 44,000 subjects, the two criteria for efficacy were the prevention of (1) a positive virological test plus (2) at least one COVID-19 symptom (pages 13-14). If the vaccine met those criteria, it would be considered to be efficacious at preventing infection. The FDA’s “Efficacy Summary” (page 32) concludes:
The data submitted in this EUA [Emergency Use Authorization] request were consistent with the recommendations set forth in the FDA Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19 and met the prespecified success criteria established in the protocol. In the planned interim and final analyses, vaccine efficacy after 7 days post Dose 2 was 95%, (95% CI 90.3; 97.6) in participants without prior evidence of SARS-CoV-2 infection and >94% in the group of participants with or without prior infection. (Emphasis added.)
See you in court, Mr. Attorney General.
It may not be strictly pertinent to the lawsuit, but it is instructive to compare the high level of efficacy of the Pfizer COVID vaccine to the usual efficacy of seasonal flu vaccines, which are in the range of 40% to 60% in preventing infection.
What is pertinent to the lawsuit is that after the initial testing and distribution of the Pfizer vaccine under an Emergency Use Authorization from the FDA, the SARS-CoV-2 virus evolved in unanticipated but significant ways. It became more transmissible and more capable of immune escape – that is, less susceptible to the immunity conferred by previous infection or vaccination. That meant that the COVID vaccines were less able to prevent infection, but – and this is important – they continued to be very effective against severe infection, hospitalization, and death.
Another important point is that the significance of COVID vaccines is further bolstered by real-world data on one of COVID’s most significant burdens – long COVID, the persistence of various signs or symptoms and damage to organs for months or even years following the acute infection. A Swedish study involving more than half a million adults found a 58% lower risk of post-COVID conditions in individuals vaccinated with “available vaccines,” which included the Pfizer vaccine and four others. Notably, a dose-response relationship showed escalating protection against long COVID with subsequent vaccine doses.
It is unfortunate that Texas’ politicians harbor antagonism toward one of the most important preventive-medicine advances of this century. By lessening vaccine uptake, their policies will have deadly consequences.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished fellow at the American Council on Science and Health. He was previously the founding director of the FDA’s Office of Biotechnology.
Using these vague “policy violations,” Google is now threatening to demonetize us. It’s part of Big Tech’s effort to silence conservative voices.
You know, after reading the article one might also wonder, “Does Dr. Henry I Miller hate Texans.”
I say this because of all the side effects of injuries and even deaths attributed to the COVID vaccine. I’m sure Dr. Miller would say, “what side effects? Can the connection to the COVID vaccine be proven?
Perhaps or perhaps not. But I believe science is really all about the study of measurement. What can now and cannot (or could not) be measured.
For instance, I believe it was back in the 1970’s the sonogram was developed and it showed the fetus as a living human baby. One of the leaders of the anti-abortion crusade at that time had been an abortionist-he was also an MD. He saw the pictures and was aghast and disgusted and ashamed at all the abortions he had performed. It was at that time he became an anti-abortionist crusader.
Thus, the science at the time before the sonogram was wrong-although many of the MD’s who performed abortions were sure they were right.
Now we get to the COVID vaccine: After all the mis and dis information that, for instance, said the vaccine was effective and safe, why should the medical profession that advocates for the COVID vaccine be trusted?
The medical “experts” also told us masks would hinder the communication of COVID. I imagine on the periphery of the mask that the Virus could stick to weave interstices, but in the main the mask pores are bigger than the virus. That was never said (I had to Google it, and Google being the woke and PC operative it was, it took me many efforts before I found the right words that Google- accepted to answer).
Even if, for arguments sake, masks do protect by inhibiting release of the virus, all this means is that the virus your body is trying to expel (in your exhalation) is breathed in again-and so your self-infecting yourself.
This was never said. I read a lot, and I was just as scared and anxious as everyone else. At least I never read it anywhere. And if it was said or written, why was this fact NOT promoted the way the COVID vaccine was.
My conclusion (although I do believe in free choice and I’m sorry to see-but understand why the Governor took his position, I can’t help but feel schadenfreude, saying to myself, “it serves them right.”
“Now the outliers are NOT those who refused to take the vaccine-like me-and were pilloried for it (in the press, by the Federal Government, by medical “experts and by layman who were scared because they knew they were so badly misinformed), now all those who argue for the efficacy of the COVID vax are the witches at the Salem trials.
It’s funny and sad, how the onslaught of of dis and misinformation was never recognized as a measurement and free choice problem. Until now!
I’m a little confused. Texas is not trying to ban the vaccine. It appears they want to ban the government from forcing people to take it. Take it if you want – your body your choice. Sound like Texas is trying to get back to America being America – Let freedom ring.
The author wants you to be confused.
The law is stopping the unconstitutional MANDATES imposed on free citizens.
That is it in one sentence.
The author needs to go sell his snake oil somewhere else.
It seems you’re not aware of the case of Jacobson v. Massachusetts (https://www.oyez.org/cases/1900-1940/197us11), in which the U.S. Supreme Court found that a smallpox vaccine mandate was a “legitimate exercise of the state’s police power to protect the public health and safety of its citizens. Local boards of health determined when mandatory vaccinations were needed, thus making the requirement neither unreasonable nor arbitrarily imposed.”
Go peddle your snake oil somewhere else.
Good article. Thanks.
In the “pivotal trial” done by Pfizer, there was NO control group. As a physician, you know that is necessary and standard. Most vaccines take up to a decade to get approved.
You also write, the vaccine is “known to prevent their employees and patients from contracting a potentially lethal infection.” Based on what? Again, the CDC and FDA dropped the ball.
I was vaccinated up the yin-yang and got the worst case of Covid based on previous colds and flu (which this basically is).
Forcing someone to take an experimental vaccine that hasn’t gone through rigorous testing is malpractice. That’s what this about. If a patient is told their doctor and staff aren’t vaccinated, they can CHOOSE to go to another doctor.
There’s a reason a number of countries have suspended the vaccine in adults born in 1991 and later. Including Sweden. How many more healthy people under the age of 25 who suddenly get a heart attack from myocarditis will it take for people like Miller to wake up.
Ah, yes, another armchair expert heard from… Pfizer’s pivotal Phase 3 trial had approximately 44,000 subjects — about 14,000 of whom were unvaccinated controls. It found that the vaccine had efficacy — the ability to prevent infection of about 95%. Read the summary that FDA presented to its vaccines advisory committee in December 2020.
Ah, yes, another smarmy author heard from.
At this point, why would any reasoning being accept a summary from the FDA?
Maybe you and Fauci could come up with a few facts to convince us rubes out here.
I live in Texas and my wife is an MD Anderson patient. MD Anderson is NOT a private hospital! It is part of the University of Texas medical system. MD Anderson requires patients and staff to wear surgical masks which are passed out at the door. As for the vaccines, I have nothing against them and believe there has been a lot of BS put out by right wing pundits, but I do not believe they should be mandated. I have had all of the recommended shots. My wife is leery of them. MD Anderson does not require patients to get the shots or even recommend them. My wife was told that it’s up to her whether she gets them or not.
Incidentally, I followed the info put out by the CDC and they DID NOT state that the vaccines would prevent the virus. Rather they said it would prevent severe cases. COVID cases dropped drastically here in Texas (and around the nation) after they started making them available. I am a disabled veteran and got mine at VA facilities. The VA highly encouraged veterans to get them, starting with older veterans like me.
Propaganda is a valuable political weapon and both sides use it. COVID became politicized early on and is still politicized. Although I know people who claim they have COVID (they used the generally unreliable tests) but as of today, the Real Clear Politics chart does not show a single recent COVID death anywhere in the United States.
Gee, you must have missed this part of the article:
“In the pivotal clinical trial, which included more than 44,000 subjects, the two criteria for efficacy were the prevention of (1) a positive virological test plus (2) at least one COVID-19 symptom (pages 13-14). If the vaccine met those criteria, it would be considered to be efficacious at preventing infection. The FDA’s “Efficacy Summary” (page 32) concludes:
“‘The data submitted in this EUA [Emergency Use Authorization] request were consistent with the recommendations set forth in the FDA Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19 and met the prespecified success criteria established in the protocol. In the planned interim and final analyses, vaccine efficacy after 7 days post Dose 2 was 95%, (95% CI 90.3; 97.6) in participants without prior evidence of SARS-CoV-2 infection and >94% in the group of participants with or without prior infection.’
As to your assertion that there hasn’t been a single recent COVID death anywhere in the U.S., see the CDC data here: https://covid.cdc.gov/covid-data-tracker/#datatracker-home. Let me summarize: As of the most recent update, 3.0% of all deaths in the U.S. were from COVID; and COVID deaths in the U.S. were up 3.4% from the previous week.
The premise of the article is inaccurate. The law bans mandates, not the jab. Why does the article not address the extraordinary number of vaccine injured? Texas pols clearly do care about their constituents, both their health and their freedom to make their own healthcare decisions.
Bollocks.
There’s no ban on the “vaccine,” just on a mandate forcing the jabs. This article is biased and doesn’t reflect the facts.
Mashing up the contentions doesn’t make a sound set of arguments. Assuming Pfizer’s original vaccine performed exactly as reported against the original strain, then the lawsuit indeed has a challenge… but that challenge, basically “it wasn’t deceptive because it did work well against the original strain, but not Pfizer’s fault that original strain subsequently evolved and escaped vaccination or natural immunity”, itself becomes the crux against a mandate’s “get vaccinated to protect others” basis.
In the author’s own words “That meant that the COVID vaccines were less able to prevent infection, but – and this is important – they continued to be very effective against severe infection, hospitalization, and death.”
It has properly become an issue of personal risk versus reward, just
Iike a flu vaccine.
Promote the benefits and clearly define the high-risk groups, explicitly define the low risk groups (seriously… healthy kids, teens, young adults and elite athletes need the jab?), stop obscuring the frequency and type of adverse effects, and let people decide for themselves.
Mandates have become non-sensical.