Cancer patients have largely been excluded from COVID-19 vaccine trials, and the American Society of Clinical Oncology is asking drug manufacturers to change that in an effort to deduce whether the safety and effectiveness extends to these often-immunocompromised patients.
The request, issued in a joint policy statement with the Friends of Cancer Research, also asked government agencies like the Food and Drug Administration to create incentives for drug companies to do so.
"The problem is that by excluding patients with cancer from the first generation of vaccine trials for COVID-19, we ended up in a challenging situation where some of the most vulnerable people had no evidence on which to base a decision about getting the vaccine," said ASCO CEO Dr. Clifford Hudis. "We end up with an information deficit, and it's a shame because paradoxically, it's a group of patients who are really most vulnerable and need to know."
The groups also ask that public health agencies and other research institutions study real world data on vaccine effectiveness for patients with cancer, especially since studies have shown they're at a heightened risk of hospitalization and death if they contract COVID-19.
There are a number of reasons people with cancer or other diseases might be excluded from trials, including that an adverse outcome may or may not be tied to the vaccine. In addition, there could be greater risk of harm if a patient is going through treatment. But Hudis said that patients should be included unless there is a specific and credible risk of harm.
Nearly 1.9 million new cancer cases will be diagnosed in the U.S. in 2021. Because there's a lack of research into how much immunity a vaccine would give a patient, ASCO recommends that even vaccinated individuals continue wearing a mask and social distance.
"Patients with certain cancers of the immune system like myeloma, or lymphoma, who really have been struggling in this era of vaccination for COVID-19 with not knowing whether they're actually gaining protection or not," Hudis said.