Question: My 28 year old daughter is a frontline worker at a state hospital and is being offered the opportunity to get the Pfizer vaccine next week. Because she has Sjogrens syndrome, we would like to know if there are any contraindications for receiving the vaccine. Were any people with Sjogrens included in the trials? Is there any available data regarding autoimmune disorders? Getting the vaccine sounds ideal, but should it be of concern for someone with Sjogrens?
Answer: Recurring reminder– I am not a medical doctor and your daughter should consult her medical doctor. Now, here’s what I know!
Pfizer Trial: The Pfizer trial included 43,538 participants with diverse backgrounds, including 7,623 individuals with underlying conditions (comorbidities). No serious safety concerns were observed, and the vaccine was found efficacious across age, sex, racial and ethnic groups, and participants with medical comorbidities. Unfortunately, safety/efficacy data on immunocompromised individuals– like people with Sjogrens syndrome– are too limited to draw conclusions. FDA issued its review of the Pfizer vaccine on Tuesday and is meeting today to discuss the emergency use authorization. In its written review, FDA states, “There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.” Pfizer is planning to conduct ongoing studies to understand outcomes in diverse populations, including immunocompromised, pregnant, and very elderly (>85 years of age) individuals. Now the question becomes– Which is more risky for your daughter, taking the vaccine next week or waiting?
Benefits/Risks: Taking the vaccine earlier means that she benefits from the protection it affords from COVID-19 and potentially benefits others (if her experience adds to the safety/efficacy data; if the vaccine minimizes transmission risk to others). It also means that she misses out on the increase in knowledge on safety/efficacy in immunocompromised individuals that time/ongoing data collection affords. Taking the vaccine later means that she benefits from increased knowledge of vaccine safety/efficacy among immunocompromised individuals, but she continues to be at risk of infection and those who are immunocompromised may be at risk of severe illness from COVID-19 (per CDC).
Background Knowledge: Since the Pfizer vaccine is an mRNA vaccine (see Q&A of 12/5), it does not have any live, attenuated virus or bacteria; those live attenuated vaccines are the ones that have been met with complications among immunocompromised individuals. As ACIP earlier stated (2013) regarding other vaccines, “All inactivated vaccines can be administered safely to persons with altered immunocompetence.” CDC also has overarching guidelines for immunization of healthcare workers, which state, “A physician must assess the degree to which an individual health-care worker (HCW) is immunocompromised. Severe immunosuppression can be the result of congenital immunodeficiency; HIV infection; leukemia; lymphoma; generalized malignancy; or therapy with alkylating agents, antimetabolites, radiation, or large amounts of corticosteroids. All persons affected by some of these conditions are severely immunocompromised, whereas for other conditions (e.g., HIV infection), disease progression or treatment stage determine the degree of immunocompromise. A determination that an HCW is severely immunocompromised ultimately must be made by his or her physician. Immunocompromised HCWs and their physicians should consider the risk for exposure to a vaccine-preventable disease together with the risks and benefits of vaccination.”