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This is big news from Pfizer and BioNTech.
This is not a trial designed to look at the vaccine’s efficacy and safety in CLL and other cancer and immune suppressed patients from what I read in the A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS protocol.
In fact, one exclusion criteria was:
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Still this an important step forward.
Since this is not a “live” vaccine, but rather a novel “RNA” vaccine, it should be safe for chronic lymphocytic leukemia patients though that is yet to be proven., The big question remains: Will it be effective?
Knowing the importance of that question to society as a whole as it mobilizes to get back to normal while still protecting the highly vulnerable, we need to work with other charities who serve folks with similar immune concerns to us CLL patients. We need to coordinate with those who represent the 3,000,000 immunosuppressed folks in the USA who either have a different cancer or HIV or are on biologicals to suppress their inflammatory diseases or are dealing with other congenital and acquired conditions that impair immune response or on immunosuppressive medications to ensure that the vaccine is well studied in this critical population.
CLL is the poster child for impaired immunity and serious outcomes with symptomatic SARS-CoV2 infections, so we need to help lead this push.
This may be the first of many effective vaccines, but we need more than an effective vaccine before we can be safe leaving our homes again.The cornerstones of our being able to re-integrate into the community will include:
- Widespread testing for COVID-19 with quick real time turn around and reliability of both the positives and negatives. We don’t have anything like this now.
- Universal mask use for a lot longer, preferably with the high-quality equivalent to N95 that offers very high level of protection to both the wearers and their contacts. A bandana around the neck won’t cut it. We might be able to dispense with this once we have # 3, but we must not abandon masks and social distancing and handwashing too soon.
- Herd immunity through widespread uptake of an effective durable vaccine. This could be a very long time coming.
- Data showing that the vaccines works work in CLL patients. This won’t be easy to prove.
- Improved treatments that lower the dismal mortality rate for symptomatic CLL patients. Smart folks are working hard on this problem.
Finally, what does 90% effective mean? 90% fewer infections? What if all those infections in the vaccine cohort were fatal and all in the control group were mild or asymptomatic? Not likely, but we don’t know. Also, there is no subgroup analysis. What if all those vaccinated who still got COVID-19 were over 65? That would be important to know. That’s the problem with a press release. It gives the topline data and little else
Still, let’s celebrate this exciting and positive vaccine news, but let’s not let down our guard or take our foot off the gas in research too soon. We still need to play it safe for some time to come, but maybe, just maybe, this is as Winston Churchill after the battle that changes the course of WWII said, “perhaps, the end of the beginning.”
Here is the official press release: Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed
Co-Founder, Executive VP and Chief Medical Officer
CLL Society, Inc.