Texas' 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.