Discussing COVID-19 vaccine risks with patients

Data continues to emerge regarding the safety of COVID-19 vaccination in pregnant and younger persons. 

When my pregnant sister asked me a few months ago if she should get vaccinated against COVID-19, I didn't hesitate to advise "yes." We now have published data suggesting that vaccination does not alter pregnancy outcomes. Researchers reviewed two-and-a-half months of data from vaccine safety surveillance systems, including over 35,000 pregnant persons, and found rates of preterm birth and miscarriage comparable to established rates pre-pandemic. Given that pregnancy confers a higher risk of COVID-19 complications, it seems reasonable to continue to advise vaccination for pregnant persons while we await more definitive, long-term data. 

Concerns about post-vaccination myocarditis have also been making headlines. A case series published last week examined myocarditis incidence in members of the United States military. 23 male patients were diagnosed with myocarditis after an evaluation for acute chest pain within 12 to 96 hours after receiving a COVID-19 vaccine. Most cases occurred after the 2nd vaccine (and all of the individuals with myocarditis after their 1st vaccine dose had previously diagnosed COVID-19). The US military administered over 3 million doses of COVID-19 vaccines; their described rate of post-vaccination myocarditis is higher than the rate of myocarditis expected in the general population, but the study authors correctly point out that this risk is still quite small compared to the risks of COVID-19 disease:

[I]t is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic. Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients....Prevalence of cardiac injury may be as high as 60%.... Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination. 

Discussing risk with patients in a meaningful way can be challenging. An 2018 FPM article on communicating risk with patients during shared decision making recommends being honest with patients about potential risks, "[u]sing frequencies with the smallest numbers possible (but not “1 in X” [as patients may worry that they'll be that 1])," and avoiding descriptive language (such as "low" or "high" risk). For example, the risk from the above study of myocarditis after COVID-19 vaccination was 19 cases per 100,000 person-years, but the risk of heart problems with COVID-19 infection is as high as 6 in 10. Family physicians are in the perfect position to have these conversations, especially since a recommendation from a trusted physician has historically been the strongest predictor of receipt of any vaccine. 

Even though the US didn't quite meet President Biden's goal of vaccinating 70% of the adult population by July 4, 20 US states and the District of Columbia did meet or surpass that goal. COVID-19 vaccine hesitancy also appears to be decreasing as 2021 progresses, so it's definitely worth continuing to have these conversations with our patients. If you'd like to learn more, the AAFP regularly updates its "COVID-19 Safety and Efficacy Data Overview" website, and this AFP editorial on "Strategies for Addressing and Overcoming Vaccine Hesitancy" contains many useful tips. The blog recently featured this guest post on "Patient-centered discussion of COVID-19 infection and mRNA vaccines" as well.