Vaccine Guidelines in the Works to Bolster Immunity

Ingrid Hein

June 19, 2018

AMSTERDAM — All people with autoimmune inflammatory rheumatic disease should be vaccinated for influenza and bacterial pneumonia when their disease is stable and before planned immunosuppression, according to vaccination guidelines that will be released later this year.

And live attenuated vaccines should not be given to newborns, particularly when the mother has been treated with biologics during the second half of her pregnancy.

The recommendations are provisional, said Ori Elkayam, MD, from the Tel Aviv Sourasky Medical Center in Israel, who is head of the task force that developed the guidelines for vaccination in adults with autoimmune inflammatory rheumatic diseases.

"We still need to talk; there are a lot of controversies," she explained here at the European League Against Rheumatism (EULAR) Congress 2018.

Previous recommendations were developed after a review of scientific studies published before the end of 2009 (Ann Rheum Dis. 2011;70:414-422).

The literature review for these newest recommendations included studies published from 2009 to September 2017. However, there were few randomized controlled trials on vaccination in people with autoimmune inflammatory rheumatic disease.

We still need to talk; there are a lot of controversies.

"We have a lot of studies, but most are small and focused on immunogenic response or the formation of antibodies, not on clinical efficacy," said Elkayam. "They do not address how much the vaccines prevent disease in this population."

"There is a lot of room for expert opinion," she added.

In fact, the 13-member task force reviewed 280 studies on the prevalence of vaccine-preventable disease in people with autoimmune inflammatory rheumatic disease, 179 on the effectiveness and safety of vaccines, and 70 on the effect of vaccines used in combination with disease-modifying antirheumatic drugs (DMARDs).

The task force members reached consensus on six overarching principles and came up with nine provisional recommendations.

During her presentation, Elkayam highlighted some of the new information that is included in the recommendations.

Specialist Responsibility

There will be a renewed focus on the responsibility of the specialist. The task force recommends that the treating specialist do an annual assessment of vaccine status and indications for further vaccination, and keep an inventory of vaccinations that have had an adverse effect on the patient.

Shared Decision-Making

The task force recommends that the risks and benefits of vaccination be discussed with the patient to open a process of shared decision-making.

Influenza and Pneumococcal Vaccines

Pneumococcal vaccination — with a combination of pneumococcal conjugate vaccine, or PCV13 (Prevnar 13, Pfizer), and pneumococcal polysaccharide vaccine, or PPSV23 (Pneumovax, Merck) — should be strongly considered for patients with autoimmune inflammatory rheumatic disease.

Household Members

Expert opinion suggests that immunocompetent members of households in which a person with autoimmune inflammatory rheumatic disease lives receive vaccines in accordance with national guidelines (except the live oral poliomyelitis vaccine).

"There are no data that say that if you vaccinate family members, you will prevent infection, but we know that the concept of herd immunity is important," Elkayam explained.


Live attenuated vaccines (particularly the oral poliomyelitis vaccine) should be avoided during the first 6 months in infants born to mothers who underwent B-cell-depleting treatment during the second half of pregnancy.

In the third trimester, immunoglobulin G molecules, which can inhibit live vaccines, pass through the placenta during treatment, said Elkayam.

A More Flexible Approach to Certain Live Attenuated Vaccines

Live attenuated vaccines should be avoided in people with autoimmune inflammatory rheumatic disease, with the possible exception of the herpes zoster and measles, mumps, and rubella (MMR) vaccines and, in special cases, such as an outbreak, the measles vaccine.

However, nonlive vaccines can be administered to people with autoimmune inflammatory rheumatic disease who are taking corticosteroids and DMARDs. "We don't see any major safety signals in these," she said.

The recommendations stress that patients should be vaccinated when their disease is stable, and before planned immunosuppression, particularly when they will be treated with biologics.

Vaccines for herpes zoster, human papillomavirus (HPV), hepatitis A and B, yellow fever, and tick-borne encephalitis should be considered when patients are at risk, the recommendations suggest.

For people with autoimmune inflammatory rheumatic disease who travel, the recommendation is to follow the general rules for vaccination, "except for live attenuated vaccines, like yellow fever and typhoid fever," Elkayam said.


"We know these recommendations have a lot of implications," Elkayam pointed out. "And that's why they're still provisional." The task force has to sit for another round of discussions on some of the controversial issues, she explained.

HPV immunization is a matter of controversy because of its autoimmune effect. For example, it can exacerbate lupus. "The vaccine is a trigger for autoimmunity, so for patients who are predisposed to autoimmunity, we must be careful with all recommendations," Elkayam said.

Discussions about MMR vaccinations for adults with autoimmune inflammatory rheumatic disease will continue. "Usually we don't have to vaccinate adults, but when it comes up, what do you do? Some think it could be risky," she noted.

For patients with mild immunosuppression, the task force is continuing its discussion on herpes zoster vaccination administered before biologics. "Not everyone agrees," Elkayam told Medscape Medical News.

Live Attenuated Vaccine Safe, Study Shows

"Our patients with inflammatory disease have a higher rate of infection, including herpes zoster," said Thomas Dörner, MD, from Charité University Hospitals in Berlin. And JAK inhibitors, a treatment for rheumatoid arthritis that is being studied for other autoimmune inflammatory diseases, "can trigger a reactivation of herpes."

However, in a study from Hong Kong presented earlier at EULAR, the live attenuated herpes zoster vaccine was well tolerated and provoked an antibody response in 45 patients with stable systemic lupus erythematosus.

This was unexpected, said Dörner, who was not involved with the study. The finding supports the need for continued research to understand vaccinations in people with autoimmune inflammatory rheumatic disease.

"We don't have robust data and we don't know when something could be a temporal coincidence," which presents a challenge, he said.

Elkayam and Dörner have disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) Congress 2018: Abstract SP0158, presented June 16, 2018; abstract OP0117, presented June 14, 2018.

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