Trust in vaccines is waning
In addition to social distancing, masking, handwashing, and generally caring about the welfare of our fellow humans, we’re all counting on an effective seasonal vaccine to eventually get us out of the COVID-19 fiasco we’re in now. But survey data shows that a huge chunk of the population is wary of a potential vaccine. This is no surprise; even routine vaccinations are met with skepticism they didn’t receive a couple decades ago, in spite of a scientific literature that overwhelmingly backs up their safety and efficacy.
As you look for data to share with employees to encourage vaccination–not just for COVID-19, but for all vaccine-preventable illnesses–pay attention to work that was just published in the Annals of Internal Medicine (paywall).
Understanding vaccine labels
Investigators from Sheba Medical Center, Rabin Medical Center, and Tel Aviv Sourasky Medical Center, all in Israel, performed a comprehensive review of “post-marketing surveillance” data over a 20-year period from January 1996 to December 2015. Specifically, they used the FDA’s Vaccine Adverse Event Reporting System (VAERS), a portal through which people can report possible medication adverse events, and then looked at the “labels” of vaccines, to see how the labels of 57 vaccines had changed over that period of time. Labels are those folded package inserts that come wrapped around any medicine bottle. Changes to labels are common after a drug hits the market. Invokana (canagliflozin), a diabetes drug that works extremely well for certain patients, for example, carries a “black box warning” on its label stating that it can increase the risk of foot amputation in certain people.
But back to our study: for each safety-related modification to a vaccine’s label, researchers noted the date of the label change, the type of safety-related label change (like addition of a boxed warning like Invokana’s, a change in reasons to avoid the vaccine, or a change in other warnings and precautions), any safety issues related to the label change, and the source of the data that led to the label change (like post-marketing surveillance, publications in medical journals, or reassessment of data from old studies).
Why vaccines labels might get changed
The investigators found that initial approval for 93% of the vaccines was supported by randomized controlled trials, the most reliable form of medical research. The studies were large, with a median 4,161 participants. So the vaccines got off to a good start. After approval, there were 58 label modifications over twenty years associated with 25 vaccines: 49 warnings and precautions, eight new contraindications to using the vaccine, and one safety-related withdrawal.
The most common source of safety data was post-marketing surveillance, which resulted in almost half of label changes. Most of that safety data was identified through the FDA’s VAERS, likely an indication of the quality of the FDA’s post-marketing surveillance of vaccines, even in the eyes of the Israeli docs doing the study. The most common safety issue resulting in a label modification was a change in the population to be vaccinated, such as adding or subtracting pregnant women or patients with abnormal immune systems. These made up about a third of label changes. Newly discovered allergies made up about a fifth of label changes, mostly due to changes in latex-containing packaging.
We should still be encouraging vaccination
In spite of overwhelming evidence of vaccine safety, the researchers write that “Rates of vaccination uptake have been decreasing in recent years, partly driven by reduced public trust and parental concerns over safety. If vaccines are perceived as unsafe, uptake in the population will decrease further, and the prevalence of infectious diseases and their associated morbidity and mortality will increase.”
It is our job as health and human resource professionals to have vaccination available, including an eventual COVID-19 vaccine, and to help our patients and employees make good decisions around vaccination. If you have had success in promoting vaccination in the past, to influenza, pneumonia, shingles, or other diseases; or if you have plans to launch a novel vaccination campaign around COVID-19 in the future, please share it with us!
As the Medical Director of the Kansas Business Group on Health I’m sometimes asked to weigh in on topics that might affect employers or employees. This was a reprint of a blog post from KBGH.