Kelvin Lee, MD, Chair of the Department of Immunology at Roswell Park and NYS COVID-19 Clinical Task Force member.
The rollout of the Pfizer and Moderna COVID-19 vaccines under Emergency Use Authorization from the FDA has raised questions about who should or should not receive it, including cancer patients. To address those questions, Roswell Park Comprehensive Cancer Center held a virtual town hall event with senior clinical staff to update them on both vaccines and their distribution to our staff and eventually our patients.
One of the panelists, Kelvin Lee, MD, Chair of the Department of Immunology at Roswell Park, is a member of the New York State COVID-19 Clinical Task Force. We’re sharing with you some of Dr. Lee's insights from the event in the hope that this information will be useful to you in determining how the vaccines might affect your patients who have cancer.
Question: What do we know about the overall safety of the vaccines?
Answer: The safety profile for both the Pfizer vaccine and the Moderna vaccine look very good. With the Pfizer vaccine, half — or 22,000 participants — received the vaccine during the trial, with the other half receiving a placebo. The side effects involved pain at the injection site, fatigue, headache, muscle ache and joint pain. Those comprised the vast majority of the side effects. They appear to be very minor, and they happened mostly within the first two days.
The Moderna vaccine appears to be similar. The side effects are what my vaccine friends call a little bit "hotter," in that there’s a higher frequency of side effects, but the side effects don’t tend to be worse. More people became fatigued, more people got headaches, and more people got a fever with the Moderna vaccine, but again, the severity was the same profile as the Pfizer vaccine. There were very few severe side effects, and most of them were not clearly attributable to the vaccine itself.
Q: Were the vaccines found to be safe for people with comorbidities?
A: Both studies looked at whether the vaccines were safe in people with comorbidities such as diabetes, liver disease, chronic lung disease, heart disease, obesity and hypertension. They found no detrimental effects of the vaccine in those populations.
That being said, we have only two months’ worth of follow-up on all these trials because of the emergency nature of their authorization. So we don't know the long-term side effects, or even if there are going to be any. But the FDA, the CDC and the State of New York are following those things very closely. The follow-up is part of the mandated pharmacovigilance plan that all the manufacturers have to put in place to follow all these effects. So we will know more as things develop.
Q: What about cancer patients?
A: Cancer patients weren't really included in either trial. There were four cancer patients out of 44,000 in the Pfizer study, and it looked like even in those patients, the vaccine did protect them. The level of protection wasn't as good as in people without cancer, but it did have a 75% efficacy protection rate, even with people potentially getting chemotherapy and treatments that we know can affect the immune system. There's still a lot to be learned in terms of vaccine performance and side effects in cancer patients. My colleagues at Roswell Park are in the process of devising research plans to follow that very closely to see how that goes going forward.
Q: When the vaccine becomes available to cancer patients, how will Roswell Park coordinate its administration with primary care physicians?
A: As our team at Roswell Park develops the prioritization algorithms for our patients, we will communicate with any primary care offices and any community practice oncologists — regardless of whether or not they're in our network — what we think the appropriate treatment plan is. We are all in this together, and as we learn more, we will provide that information. If we find that certain subsets of patients probably shouldn't get the vaccines because they have no efficacy or have adverse events, we will inform our colleagues in the community.
I think the only way we're going to learn how the vaccine performs and the side effects in the cancer population is with open communication.