What FDA Pfizer Approval Means

Today, the FDA approved the Pfizer COVID vaccine.  This vaccine is the first of the three vaccines authorized under EUA to achieve this status.  In this blog, I’ll highlight what this approval means.  Obviously, this is just a first look at the information released by the FDA today.  I’ve not studied the Full Prescribing Information in detail.  There may be more changes that I have overlooked; I will update you on these as they become apparent.    

First, let’s talk about what hasn’t changed.  

• The vaccine has not changed.  There have been no modifications to the vaccine.  The vaccine that was injected before approval is the same as the vaccine given after approval.
• The warnings on the vaccine label have not changed.  The Highlights of Prescribing Information issued with the vaccine approval have the same warnings that were listed for the pre-approval vaccine.  These include acute allergic reactions (anaphylaxis), myocarditis and pericarditis, syncope (fainting), altered Immunocompetence, and limitation of effectiveness.  Furthermore, Pfizer does not assure the safety of the vaccine in pregnancy or breast-feeding mothers.  
• Vaccine experience is still limited.  Although Pfizer updated its clinical trial data to include many more patients, and has expanded the observation period over more time, there are still no long-term clinical trials to study potential adverse effects this vaccine may have three, five, or ten years down the road.  

So far, not much difference.  What has changed?

• The vaccine is now called “COMIRNATY”.  If anyone understands why they chose this name, please let me know. It’s not obvious to me.  
• Approval does not include 12-15 year-olds.  On May 10, the EUA for Pfizer vaccination was amended to include children down to 12 years of age.  This vaccine is now approved for individuals 16 years and older.  Children aged 12-15 may still receive the vaccination under a new reissued EUA.
• Removal of statement warning of unknown future risks.  The previous Fact Sheet for Healthcare Providersincluded the following statement: “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.”  This statement is not present in the Highlights of Prescribing Information issued with this approval.  However, the Fact Sheet for Recipients and Caregivers still contains the following statement: “These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.”
• The Pfizer COVID Vaccine is no longer “unapproved”.  This may not seem like much of a substantiative change, but the psychologic and motivational effect of this change will likely be significant.  Those advocating vaccine resistance relished referring to COVID Vaccines as “experimental” because, technically, they were.  Janssen and Moderna still are.  You can’t call the Pfizer COVID vaccine “experimental” anymore because, technically, it’s not.  This semantic change will embolden governments and employers to pursue vaccine mandates.

But this brings us to a few more things that haven’t changed.  I have argued that vaccine mandates are wrong strategically, wrong temporally, and wrong ethically.  There is nothing about FDA approval of vaccine that changes my opinion on this.  Ethical physicians have a duty to speak out on issues affecting patient safety, even and especially during a pandemic.  

The FDA can and has made mistakes in its approval process before.  It will again.  It may have in this instance; time will tell.  But if the FDA has bowed to political pressure to short-circuit this approval, the long-term consequences will be deadly.  Not just to the health and wellbeing of vaccine recipients, but also to the trust that is the cornerstone of America’s healthcare quality. 

According to the AMA Code of Ethics, individuals must participate in their personal healthcare decisions through the process of informed consent  which requires complete, clear, and honest disclosures of all known and potential risks and benefits.  Approved vaccines are not exempted from this moral obligation.  An article published recently in American Journal of Law & Medicine, states that “to be autonomous, decisions need to be based on full, accessible information and reached without coercion.”  No matter how well intentioned, coercion by government or employer cannot be part of informed consent process.  Not in the Land of the Free.  Not in the Home of the Brave.