FDA Chief Warns US Immunity Is ‘At Risk’ as More People Decline Vaccinations
Vaccine
Health workers prepare a vaccine

The rising number of US citizens declining vaccinations is threatening population immunity to certain diseases, according to two US Food and Drug Administration (FDA) leaders.

“The situation has now deteriorated to the point that population immunity against some vaccine-preventable infectious diseases is at risk, and thousands of excess deaths are likely to occur this season due to illnesses amenable to prevention or reduction in severity of illness with vaccines,” according to FDA Commissioner Dr Robert Califf and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research writing in the journal, JAMA.

They cite a recent measles outbreak in central Ohio involving 85 children, 36 of whom (42%) had to be hospitalized for complications.

High-income parents ‘prefer social media’

“It is sobering to note that vaccine hesitancy to childhood vaccines, such as the measles, mumps, and rubella vaccine, has been found to cluster in middle- to high-income areas among parents with at least a college degree who preferred social media narratives over evidence-based vaccine information delivered by clinicians,” they note.

In addition, only 35% of people older than 65 have had the updated COVID-19 vaccine (XBB.1.5 monovalent), which is about half the rate in this age group in the UK.

“Contrary to a wealth of misinformation available on social media and the internet, data from various studies indicate that since the beginning of the COVID-19 pandemic, tens of millions of lives were saved by vaccination. The benefits of these vaccines in prevention were largest in older individuals. However, studies show that people of all ages who are up to date on vaccination benefit and have a lower risk of developing long COVID,” they note.

Mortality per Million Individuals From COVID-19 in the US Depending on Vaccination Status

Uptake of the influenza vaccine amongst US citizens over 65 is also inadequate. 

“Vaccination rates against these respiratory pathogens are inadequate, and this is most distressing in older individuals in whom the benefits of vaccination in reducing hospitalization and death are eminently clear.”

Califf and Marks urge the clinical and biomedical community to “redouble efforts to provide accurate plain-language information” about the benefits and risks of vaccination. 

“We believe that the best way to counter the current large volume of vaccine misinformation is to dilute it with large amounts of truthful, accessible scientific evidence,” they argue.

Clinicians who provide care are the most trusted source of information about health decisions, while retail pharmacists perform this role for people who lack a primary care clinician or who are uninsured.

“All those working in health care, while being straightforward about the risks, need to better educate people regarding the benefits of vaccination, so that individuals can make well-informed choices based on accurate scientific evidence,” they urge.

Ironically, 2024 is the fiftieth anniversary of the World Health Organization’s Expanded Programme on Immunization (EPI), which aimed to ensure equitable access to life-saving vaccines for every child, regardless of their geographic location or socioeconomic status. 

Texas case against Pfizer 

The FDA leaders’ appeal comes shortly after Texas Attorney General Ken Paxton launched court action against Pfizer late last year for “false, deceptive, and misleading acts and practices” relating to its COVID-19 vaccine.

“The pharmaceutical company’s widespread representation that its vaccine possessed 95% efficacy against infection was highly misleading,” according to Paxton in a media release.

Paxton, who is seeking more than $10 million in fines, claims he is “pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies”.

In response, Pfizer has applied for the case to be moved to the Northern District of Texas, saying that the case has no merit. It also claims that it is immune from liability under federal and state law in terms of the Public Readiness and Emergency Preparedness (PREP) Act for Medical Countermeasures Against COVID-19 passed in 2020.

“The FDA … is in the best position to resolve questions concerning the accuracy and propriety of statements Pfizer allegedly made concerning the COVID-19 vaccine, which the FDA itself vetted, authorized, and approved,” according to Pfizer in its legal filing.

Paxton’s court action has been hailed by anti-vaxxers on social media, many of whom are supporters of Donald Trump, in a country where uptake of vaccinations have become politicised, particularly during the pandemic. Republican supporters are significantly less likely to be vaccinated against COVID-19 than Democrats and died in greater numbers during the pandemic.

Image Credits: WHO Afro region, JAMA.

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